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Protocol summary
Preterm labor and birth is associated with several neonatal complications including respiratory distress syndrome (RDS) and intraventricular hemorrhage (IVH). Differentiating true and false labor pain is a dilemma to obstetricians. We performed this study to elucidate the role of cervical length measurement in prediction of preterm birth in those with threatened preterm labor.
This was a randomized clinical trial being performed at Hafez Hospital of Shiraz University of Medical Sciences. We included 120 women presenting with painful uterine contractions before 34 weeks of gestation randomly assigned to undergo measurement of cervical length (n=65) and to receive tocolysis. Those with cervical length <15 mm received tocolysis. However those with cervical length ≥15 mm were managed expectantly. Delivery within 7 days of presentation was the primary outcome.
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Preterm labor and birth is associated with several neonatal complications including respiratory distress syndrome (RDS) and intraventricular hemorrhage (IVH). Differentiating true and false labor pain is a dilemma to obstetricians. We performed this study to elucidate the role of cervical length measurement in prediction of preterm birth in those with threatened preterm labor. This was a randomized clinical trial being performed at Hafez Hospital of Shiraz University of Medical Sciences. We included 120 women presenting with painful uterine contractions before 34 weeks of gestation randomly assigned to undergo measurement of cervical length (n=65) and to receive tocolysis. Those with cervical length <15 mm received tocolysis. However those with cervical length ≥15 mm were managed expectantly. Delivery within 7 days of presentation was the primary outcome.
زايمان زودرس علت عوارض نوزادي بسياري از جمله: سندرم ديسترس تنفسي (RDS) و خونريزي مغزي
(IVH) مي باشد. افتراق دردهاي زايماني زودرس واقعي و كاذب از نظر متخصصين زايمان مسئله بسيار پيچيده اي مي باشد. لذا در اين مطالعه به منظور روشن ساختن نقش اندازه گيري طول دهانه رحم به وسيله سونوگرافي در پيش بيني زايمان زودرس در بيماران زود رس انجام شده است.
اين مطالعه به صورت كارآزمايي باليني با توزيع تصادفي نمونه ها در بيمارستان آموزشي درماني حافظ وابسته به
دانشگاه علوم پزشكي شيراز انجام شده است. دراين مطالعه 120خانم مراجعه كننده با انقباضات دردناك رحمي و سن حاملگي كمتر از 34 هفته به صورت تصادفي انتخاب شدند و در تعداد 65 نفر به منظور تعيين دريافت توكوليزيس سونوگرافي طول دهانه رحم انجام شد. در بيماراني كه طول دهانه رحم آنها بيش از 15ميلي متر بود به صورت انتظاري درمان شدند. زايمان در طي 7 روز بعد از بروز آنها به عنوان هدف نهايي مطالعه در نظر گرفته خواهد شد.
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زايمان زودرس علت عوارض نوزادي بسياري از جمله: سندرم ديسترس تنفسي (RDS) و خونريزي مغزي (IVH) مي باشد. افتراق دردهاي زايماني زودرس واقعي و كاذب از نظر متخصصين زايمان مسئله بسيار پيچيده اي مي باشد. لذا در اين مطالعه به منظور روشن ساختن نقش اندازه گيري طول دهانه رحم به وسيله سونوگرافي در پيش بيني زايمان زودرس در بيماران زود رس انجام شده است. اين مطالعه به صورت كارآزمايي باليني با توزيع تصادفي نمونه ها در بيمارستان آموزشي درماني حافظ وابسته به دانشگاه علوم پزشكي شيراز انجام شده است. دراين مطالعه 120خانم مراجعه كننده با انقباضات دردناك رحمي و سن حاملگي كمتر از 34 هفته به صورت تصادفي انتخاب شدند و در تعداد 65 نفر به منظور تعيين دريافت توكوليزيس سونوگرافي طول دهانه رحم انجام شد. در بيماراني كه طول دهانه رحم آنها بيش از 15ميلي متر بود به صورت انتظاري درمان شدند. زايمان در طي 7 روز بعد از بروز آنها به عنوان هدف نهايي مطالعه در نظر گرفته خواهد شد.
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This study to elucidate the role of cervical length measurement in prediction of preterm birth in those with threatened preterm labor.
This study to elucidate the role of cervical length measurement in prediction of preterm birth in those with threatened preterm labor.
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اين مطالعه به منظور روشن ساختن نقش اندازه گيري طول دهانه رحم به وسيله سونوگرافي در پيش بيني زايمان زودرس در بيماران با درد زایمانی زود رس انجام شده است.
اين مطالعه به منظور روشن ساختن نقش اندازه گيري طول دهانه رحم به وسيله سونوگرافي در پيش بيني زايمان زودرس در بيماران با درد زایمانی زود رس انجام شده است.
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We included 120 women presenting with painful uterine contractions before 34 weeks of gestation randomly assigned to undergo measurement of cervical length (n=65) and to receive tocolysis. Those with cervical length <15 mm received tocolysis. However those with cervical length ≥15 mm were managed expectantly. Delivery within 7 days of presentation was the primary outcome.
We included 120 women presenting with painful uterine contractions before 34 weeks of gestation randomly assigned to undergo measurement of cervical length (n=65) and to receive tocolysis. Those with cervical length <15 mm received tocolysis. However those with cervical length ≥15 mm were managed expectantly. Delivery within 7 days of presentation was the primary outcome.
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مطالعه 120خانم مراجعه كننده با انقباضات دردناك رحمي و سن حاملگي كمتر از 34 هفته به صورت تصادفي انتخاب شدندو در تعداد 65 نفر به منظور تعيين دريافت توكوليزيس سونوگرافي طول دهانه رحم انجام شد. در بيماراني كه طول دهانه رحم آنها بيش یا مساوی با 15ميلي متر بود به صورت انتظاري درمان شدند. زايمان در طي 7 روز بعد از بروز آن به عنوان پیامد اولیه مطالعه در نظر گرفته خواهد شد.
مطالعه 120خانم مراجعه كننده با انقباضات دردناك رحمي و سن حاملگي كمتر از 34 هفته به صورت تصادفي انتخاب شدندو در تعداد 65 نفر به منظور تعيين دريافت توكوليزيس سونوگرافي طول دهانه رحم انجام شد. در بيماراني كه طول دهانه رحم آنها بيش یا مساوی با 15ميلي متر بود به صورت انتظاري درمان شدند. زايمان در طي 7 روز بعد از بروز آن به عنوان پیامد اولیه مطالعه در نظر گرفته خواهد شد.
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this study to elucidate the role of cervical length measurement in prediction of preterm birth in those with threatened preterm labor. This was a randomized clinical trial being performed at Hafez Hospital of Shiraz University of Medical Sciences. We included 120 women presenting with painful uterine contractions before 34 weeks of gestation randomly assigned to undergo measurement of cervical length (n=65) and to receive tocolysis. Those with cervical length <15 mm received tocolysis. However those with cervical length ≥15 mm were managed expectantly. Delivery within 7 days of presentation was the primary outcome.
this study to elucidate the role of cervical length measurement in prediction of preterm birth in those with threatened preterm labor. This was a randomized clinical trial being performed at Hafez Hospital of Shiraz University of Medical Sciences. We included 120 women presenting with painful uterine contractions before 34 weeks of gestation randomly assigned to undergo measurement of cervical length (n=65) and to receive tocolysis. Those with cervical length <15 mm received tocolysis. However those with cervical length ≥15 mm were managed expectantly. Delivery within 7 days of presentation was the primary outcome.
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اين مطالعه به صورت كارآزمايي باليني با توزيع تصادفي نمونه ها در بيمارستان آموزشي درماني حافظ وابسته به دانشگاه علوم پزشكي شيراز انجام شده است. دراين مطالعه 120خانم مراجعه كننده با انقباضات دردناك رحمي و سن حاملگي كمتر از 34 هفته به صورت تصادفي انتخاب شدند و در تعداد 65 نفر به منظور تعيين دريافت توكوليزيس سونوگرافي طول دهانه رحم انجام شد. در بيماراني كه طول دهانه رحم آنها بيش از 15ميلي متر بود به صورت انتظاري درمان شدند. زايمان در طي 7 روز بعد از بروز آنها به عنوان هدف نهايي مطالعه در نظر گرفته خواهد شد.
اين مطالعه به صورت كارآزمايي باليني با توزيع تصادفي نمونه ها در بيمارستان آموزشي درماني حافظ وابسته به دانشگاه علوم پزشكي شيراز انجام شده است. دراين مطالعه 120خانم مراجعه كننده با انقباضات دردناك رحمي و سن حاملگي كمتر از 34 هفته به صورت تصادفي انتخاب شدند و در تعداد 65 نفر به منظور تعيين دريافت توكوليزيس سونوگرافي طول دهانه رحم انجام شد. در بيماراني كه طول دهانه رحم آنها بيش از 15ميلي متر بود به صورت انتظاري درمان شدند. زايمان در طي 7 روز بعد از بروز آنها به عنوان هدف نهايي مطالعه در نظر گرفته خواهد شد.
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Women with cervical dilatation >5 cm, polyhydramnios, macrosomia, multiple pregnancy, suspected intrauterine infection, rupture of membranes, vaginal bleeding were excluded.
Women with cervical dilatation >5 cm, polyhydramnios, macrosomia, multiple pregnancy, suspected intrauterine infection, rupture of membranes, vaginal bleeding were excluded.
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خانم های باردار طول سرویکس بیشتر از 5 سانتی متر؛ پلی هیدرامنیوس؛ ماکروزومی؛ حاملگی چندقلویی؛ عفونت داخل رحمی؛ پارگی کیسه آب؛ خونریزی واژینال از مطالعه خارج شدند.
خانم های باردار طول سرویکس بیشتر از 5 سانتی متر؛ پلی هیدرامنیوس؛ ماکروزومی؛ حاملگی چندقلویی؛ عفونت داخل رحمی؛ پارگی کیسه آب؛ خونریزی واژینال از مطالعه خارج شدند.
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65 patients undergoing cervical length measurement by transvaginal
ultrasonography for further management (case group) and 55 patients who received tocolytic and corticosteroid therapy (control group)
65 patients undergoing cervical length measurement by transvaginal ultrasonography for further management (case group) and 55 patients who received tocolytic and corticosteroid therapy (control group)
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65 بیمار تحت اندازه گیری طول دهانه رحم به روش ترانس واژینال سونوگرافی برای درمان بیشتر (گروه مورد) و 55 بیمار تحت درمان توکولیتیک و کورتیکواستروئید (گروه شاهد)
65 بیمار تحت اندازه گیری طول دهانه رحم به روش ترانس واژینال سونوگرافی برای درمان بیشتر (گروه مورد) و 55 بیمار تحت درمان توکولیتیک و کورتیکواستروئید (گروه شاهد)
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cervical length, Delivery within 7 days
cervical length, Delivery within 7 days
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طول دهانه رحم، زایمان در کمتر از 7 روز از پذیرش
طول دهانه رحم، زایمان در کمتر از 7 روز از پذیرش
General information
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120
120
2012-02-20, 1390/12/01
2010-10-01, 1389/07/09
20122010-0210-2001 00:00:00
2016-10-22, 1395/08/01
2015-02-01, 1393/11/12
20162015-1002-2201 00:00:00
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2010-10-01, 1389/07/09
2010-10-01 00:00:00
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2015-02-01, 1393/11/12
2015-02-01 00:00:00
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2015-02-01, 1393/11/12
2015-02-01 00:00:00
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Add results and modify some items
Add results and modify some items
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اضافه کردن نتایج و اصلاح برخی موارد
اضافه کردن نتایج و اصلاح برخی موارد
At least 4 contractions in 20 min interval
Single pregnancy
Gestational age before 34 weeks
Maternal age 18-40 y
At least 4 contractions in 20 min interval Single pregnancy Gestational age before 34 weeks Maternal age 18-40 y
حداقل 4 انقباض در دقیقه
حاملگی تک قلو
سن حاملگی زیر 34 هفته
سن مادر بین 18-40 سال
حداقل 4 انقباض در دقیقه حاملگی تک قلو سن حاملگی زیر 34 هفته سن مادر بین 18-40 سال
Polyhydramnios (amniotic fluid index greater than 24 cm)
Macrosomia(estimated fetal weight >90th centile)
Rupture of membranes
Cervical dilatation >5 cm
Multiple pregnancy
Suspected intrauterine infection
Vaginal bleeding (more than bloody show)
Major medical disorders in mother
Contraindicated for vaginal delivery(e.g. placenta previa)
Non-reassuring fetal heart monitoring
Fetal anomaly
Any contraindication for administer of beta-sympathomimetic drugs and previous treatment with tocolytics/corticosteroid in this pregnancy
Polyhydramnios (amniotic fluid index greater than 24 cm) Macrosomia(estimated fetal weight >90th centile) Rupture of membranes Cervical dilatation >5 cm Multiple pregnancy Suspected intrauterine infection Vaginal bleeding (more than bloody show) Major medical disorders in mother Contraindicated for vaginal delivery(e.g. placenta previa) Non-reassuring fetal heart monitoring Fetal anomaly Any contraindication for administer of beta-sympathomimetic drugs and previous treatment with tocolytics/corticosteroid in this pregnancy
پلی هیدرامنیوس (حجم مایع آمنیون بیشتر از 24 سانتیمتر)
ماکروزمی(وزن تخمینی بیشتر از 90 سنتایل)
پارگی کیسه آمنیون
اتساع دهانه رحم بیشتر از 5 سانتیمتر
حاملگی چندقلویی
عفونت داخل رحمی
خونریزی واژینال
اختلال عمده پزشکی در مادر
منع زایمان واژینال(مانند جفت سرراهی)
نوار قلب جنین ابنورمال
آنومالی جنین
هرگونه منع مصرف داروهای بتا سمپاتومیمتیک و درمان قبلی با توکولیتیک/کورتیکواستروئید در این بارداری
پلی هیدرامنیوس (حجم مایع آمنیون بیشتر از 24 سانتیمتر) ماکروزمی(وزن تخمینی بیشتر از 90 سنتایل) پارگی کیسه آمنیون اتساع دهانه رحم بیشتر از 5 سانتیمتر حاملگی چندقلویی عفونت داخل رحمی خونریزی واژینال اختلال عمده پزشکی در مادر منع زایمان واژینال(مانند جفت سرراهی) نوار قلب جنین ابنورمال آنومالی جنین هرگونه منع مصرف داروهای بتا سمپاتومیمتیک و درمان قبلی با توکولیتیک/کورتیکواستروئید در این بارداری
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Based on the unit numbers, patients were randomly assigned to two groups using a computerized random digit generator.
Based on the unit numbers, patients were randomly assigned to two groups using a computerized random digit generator.
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بر اساس شماره پذیرش بیماران، با استفاده از عدد تصادفی کامپیوتری به طور تصادفی در دو گروه قرار گرفتند.
بر اساس شماره پذیرش بیماران، با استفاده از عدد تصادفی کامپیوتری به طور تصادفی در دو گروه قرار گرفتند.
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Patients will receive A medication based on computerized random digit number in double blind method and a code will be allocated to each patient (1 to 120) that will be encoded at the end of the study. The patients and the designer and drug distributors are not aware of the drug pack. This study is the second phase of trial.
Patients will receive A medication based on computerized random digit number in double blind method and a code will be allocated to each patient (1 to 120) that will be encoded at the end of the study. The patients and the designer and drug distributors are not aware of the drug pack. This study is the second phase of trial.
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بیماران بصورت تصادفی دوسویه کور و براساس شماره تصادفی کامپیوتری دارو را دریافت می کنند.به هر بیمار یک کد از ۱ تا 120 تعلق می گیرد که در پایان مطالعه کدگشایی خواهد شد. بیمار, طراح و توزیع کننده دارو از محتوای پک دارویی ( توکلیت ) مطلع نمی باشند. این مطالعه مرحله دو کارآزمایی محسوب می شود
بیماران بصورت تصادفی دوسویه کور و براساس شماره تصادفی کامپیوتری دارو را دریافت می کنند.به هر بیمار یک کد از ۱ تا 120 تعلق می گیرد که در پایان مطالعه کدگشایی خواهد شد. بیمار, طراح و توزیع کننده دارو از محتوای پک دارویی ( توکلیت ) مطلع نمی باشند. این مطالعه مرحله دو کارآزمایی محسوب می شود
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Primary outcomes
#1
Before treatment
At the beginning of the enrollment and after persistent uterine contractions more than 4 hours
Before treatmentAt the beginning of the enrollment and after persistent uterine contractions more than 4 hours
قبل از شروع درمان
ابتدای ورود به مطالعه و 4 ساعت بعد از ابقای انقاباضات رحمی
قبلابتدای ورود به مطالعه و 4 ساعت بعد از شروع درمانابقای انقاباضات رحمی
#2
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Preterm birth
Preterm birth
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زایمان زودرس
زایمان زودرس
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7 days after enrollment
7 days after enrollment
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7 روز بعد از ورود به مطالعه بالینی
7 روز بعد از ورود به مطالعه بالینی
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Delivery
Delivery
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تولد نوزاد
تولد نوزاد
Intervention groups
#1
Betamethasone is given in two doses to patients with cervical length less than 15 mm.
Those who were assigned to the case group underwent transvaginal ultrasonography for measuring the cervical length by one expert obstetrician. Neither residents nor sonographers were not aware of this clinical trial. Those with cervical length <15 mm were received tocolytic ( Nifedipne (tablet 10 mg manufactured by toliddaru Pharmaceutical Company ) 20 to 30 mg orally initial loading dose, then followed 10 mg every 6 hours up to 48 hours with a maximum dose of 180 mg/day) and corticosteroid therapy according to the hospital protocol. Expectantly management was performed when cervical length was ≥15 mm, but with persistent uterine contractions more than 4 hr, another cervical measurement was performed by the same operator. If the cervical length was become <15 mm tocolytic and antenatal corticosteroids were given.
Betamethasone is given in two dosesThose who were assigned to patientsthe case group underwent transvaginal ultrasonography for measuring the cervical length by one expert obstetrician. Neither residents nor sonographers were not aware of this clinical trial. Those with cervical length less<15 mm were received tocolytic ( Nifedipne (tablet 10 mg manufactured by toliddaru Pharmaceutical Company ) 20 to 30 mg orally initial loading dose, then followed 10 mg every 6 hours up to 48 hours with a maximum dose of 180 mg/day) and corticosteroid therapy according to the hospital protocol. Expectantly management was performed when cervical length was ≥15 mm, but with persistent uterine contractions more than 4 hr, another cervical measurement was performed by the same operator. If the cervical length was become <15 mm tocolytic and antenatal corticosteroids were given.
بتامتازون در دو دوز به بیماران که طول سرویکس کمتر از 15 میلی متر است داده می شود.
در افرادی که طول سرویکس در ابتدای مطالعه زیر 15 میلی متر بود توکلیت (نیفدیپن (قرص 10 میلی گرمی ساخت شرکت داروسازی تولیددارو) 20 تا 30 میلی گرم دوز اولیه خوراکی، سپس 10 میلی گرم هر 6 ساعت تا 48 ساعت با حداکثر دوز 180 میلی گرم در روز) و استروئید داده شد و افرادی که بالای 15 میلی متر بود بعد از 4 ساعت مجدد طول سرویکس اندازه گیری شد و در صورت ماهش طول سرویکی به 15 توکلیتیک و کورتیکواستروئید داده شد.
بتامتازون در دو دوز به بیمارانافرادی که طول سرویکس کمتر ازدر ابتدای مطالعه زیر 15 میلی متر استبود توکلیت (نیفدیپن (قرص 10 میلی گرمی ساخت شرکت داروسازی تولیددارو) 20 تا 30 میلی گرم دوز اولیه خوراکی، سپس 10 میلی گرم هر 6 ساعت تا 48 ساعت با حداکثر دوز 180 میلی گرم در روز) و استروئید داده می شودشد و افرادی که بالای 15 میلی متر بود بعد از 4 ساعت مجدد طول سرویکس اندازه گیری شد و در صورت ماهش طول سرویکی به 15 توکلیتیک و کورتیکواستروئید داده شد.
#2
Patients with cervical length greater than 15 mm are only under observation.
In 55 patients that were diagnosed with preterm labor pain without check cervical length, tocolytic and antenatal corticosteroids were given.
PatientsIn 55 patients that were diagnosed with preterm labor pain without check cervical length greater than 15 mm are only under observation, tocolytic and antenatal corticosteroids were given.
در بیماران که طول سرویکس بیشتر از 15 میلی متر است فقط تحت نظر هستند.
بدون اندازه گیری طول سرویکس و صرفا با تشخیص زایمان زودرس توکلیتیک و کورتیکواستروئید داده شد.
در بیماران کهبدون اندازه گیری طول سرویکس بیشتر از 15 میلی متر است فقط تحت نظر هستندو صرفا با تشخیص زایمان زودرس توکلیتیک و کورتیکواستروئید داده شد.
Recruitment centers
#1
Name of recruitment center - English: Hafez hospital
Name of recruitment center - Persian: بیمارستان حافظ
Full name of responsible person - English: Syedeh Marjan Hosseni
Full name of responsible person - Persian: سیده مرجان حسینی
Street address - English:
Street address - Persian:
City - English: Shiraz
City - Persian: شیراز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Hafez hospital
Name of recruitment center - Persian: بیمارستان حافظ
Full name of responsible person - English: Syedeh Marjan Hosseni
Full name of responsible person - Persian: سیده مرجان حسینی
Street address - English: Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran
Street address - Persian: شیراز، بلوار شهید چمران، بیمارستان حافظ، مرکز تحقیقات بیماری های مادر و جنین (پریناتالوژی)
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7184837786
Phone: +98 71 3647 9830
Fax:
Email: hafez_perina@sums.ac.ir
Web page address:
Name of recruitment center - English: Hafez hospital Name of recruitment center - Persian: بیمارستان حافظ Full name of responsible person - English: Syedeh Marjan Hosseni Full name of responsible person - Persian: سیده مرجان حسینی Street address - English: Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran Street address - Persian: شیراز، بلوار شهید چمران، بیمارستان حافظ، مرکز تحقیقات بیماری های مادر و جنین (پریناتالوژی) City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7184837786 Phone: +98 71 3647 9830 Fax: Email: hafez_perina@sums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research of Shiraz University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Dr Basir Hashemi
Full name of responsible person - Persian: دکتر بصیر هاشمی
Street address - English: Shiraz University of Medical Sciences, Zand Street, Shiraz
Street address - Persian: شیراز؛ خیابان زند؛ دانشگاه علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research of Shiraz University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Dr Basir Hashemi
Full name of responsible person - Persian: دکتر بصیر هاشمی
Street address - English: Shiraz University of Medical Sciences, Zand Street, Shiraz
Street address - Persian: شیراز؛ خیابان زند؛ دانشگاه علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 34786-71946
Phone: +98 71 3647 9830
Fax:
Email: hashemib@sums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research of Shiraz University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شیراز Full name of responsible person - English: Dr Basir Hashemi Full name of responsible person - Persian: دکتر بصیر هاشمی Street address - English: Shiraz University of Medical Sciences, Zand Street, Shiraz Street address - Persian: شیراز؛ خیابان زند؛ دانشگاه علوم پزشکی شیراز City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 34786-71946 Phone: +98 71 3647 9830 Fax: Email: hashemib@sums.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Shiraz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Dr. Seyedeh Marjan Hosseni
Full name of responsible person - Persian: دکتر سیده مرجان حسینی
Position - English: Rezedent of Obstetrics & GYN
Position - Persian: رزیدنت زنان و زایمان
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shiraz University of Medical Sciences، Zand street
Street address - Persian: خیابان زند، دانشگاه علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +32 332365
Mobile: 00
Fax:
Email: marjanhosseini2410@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Shiraz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Dr. Seyedeh Marjan Hosseni
Full name of responsible person - Persian: دکتر سیده مرجان حسینی
Position - English: Rezedent of Obstetrics & GYN
Position - Persian: رزیدنت زنان و زایمان
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shiraz University of Medical Sciences، Zand street
Street address - Persian: خیابان زند، دانشگاه علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 34786-71946
Phone: +32 332365
Mobile: 009177159284
Fax:
Email: marjanhosseini2410@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Shiraz University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز Full name of responsible person - English: Dr. Seyedeh Marjan Hosseni Full name of responsible person - Persian: دکتر سیده مرجان حسینی Position - English: Rezedent of Obstetrics & GYN Position - Persian: رزیدنت زنان و زایمان Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Shiraz University of Medical Sciences، Zand street Street address - Persian: خیابان زند، دانشگاه علوم پزشکی شیراز City - English: Shiraz City - Persian: شیراز Province: Fars Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 34786-71946 Phone: +32 332365 Mobile: 00009177159284 Fax: Email: marjanhosseini2410@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Shiraz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Dr. Homeira Vafaei
Full name of responsible person - Persian: دکتر حمیرا وفایی
Position - English: Professor of Obstetrics & GYN
Position - Persian: متخصص زنان و زایمان
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shiraz University of Medical Science, Zand Street
Street address - Persian: خیابان زند، دانشگاه علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 71 3233 2365
Mobile: +98 917 343 0210
Fax:
Email: vafaeih@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Shiraz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Dr. Homeira Vafaei
Full name of responsible person - Persian: دکتر حمیرا وفایی
Position - English: Professor of Obstetrics & GYN
Position - Persian: متخصص زنان و زایمان
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shiraz University of Medical Science, Zand Street
Street address - Persian: خیابان زند، دانشگاه علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 34786-71946
Phone: +98 71 3233 2365
Mobile: +98 917 343 0210
Fax:
Email: vafaeih@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Shiraz University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز Full name of responsible person - English: Dr. Homeira Vafaei Full name of responsible person - Persian: دکتر حمیرا وفایی Position - English: Professor of Obstetrics & GYN Position - Persian: متخصص زنان و زایمان Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Shiraz University of Medical Science, Zand Street Street address - Persian: خیابان زند، دانشگاه علوم پزشکی شیراز City - English: Shiraz City - Persian: شیراز Province: Fars Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 34786-71946 Phone: +98 71 3233 2365 Mobile: +98 917 343 0210 Fax: Email: vafaeih@gmail.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Shiraz University of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Dr. Seydeh Marjan Hosseni
Full name of responsible person - Persian: دکتر سید مرجان حسینی
Position - English: Professor of Obstetrics & GYN
Position - Persian: متخصص زنان و زایمان
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shiraz University of Medical Science , Zand Street
Street address - Persian: خیابان زند، دانشگاه علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 71 3233 2365
Mobile: 00
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Shiraz University of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز
Full name of responsible person - English: Dr. Seydeh Marjan Hosseni
Full name of responsible person - Persian: دکتر سید مرجان حسینی
Position - English: Professor of Obstetrics & GYN
Position - Persian: متخصص زنان و زایمان
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shiraz University of Medical Science , Zand Street
Street address - Persian: خیابان زند، دانشگاه علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 34786-71946
Phone: +98 71 3233 2365
Mobile: 009177159284
Fax:
Email: hafez_perina@sums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Shiraz University of Medical Science Name of organization / entity - Persian: دانشگاه علوم پزشکی شیراز Full name of responsible person - English: Dr. Seydeh Marjan Hosseni Full name of responsible person - Persian: دکتر سید مرجان حسینی Position - English: Professor of Obstetrics & GYN Position - Persian: متخصص زنان و زایمان Latest degree: specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Shiraz University of Medical Science , Zand Street Street address - Persian: خیابان زند، دانشگاه علوم پزشکی شیراز City - English: Shiraz City - Persian: شیراز Province: Fars Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 34786-71946 Phone: +98 71 3233 2365 Mobile: 00009177159284 Fax: Email: hafez_perina@sums.ac.ir Web page address:
Sharing plan
yes
yes
undecided
undecided
yes
yes
yes
yes
yes
yes
na
na
na
na
empty
Participant data file: Information and research data Ethic form: Complete the ٍEthic form by the patient
Participant data file: Information and research data Ethic form: Complete the ٍEthic form by the patient
empty
فایل داده شرکت کنندگان: اطلاعات و داده های حاصل از پژوهشی فرم رضایت آگاهانه: تکمیل فرم رضایت آگاهانه توسط بیمار
فایل داده شرکت کنندگان: اطلاعات و داده های حاصل از پژوهشی فرم رضایت آگاهانه: تکمیل فرم رضایت آگاهانه توسط بیمار
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Participant data file:2023Ethic form: 2023
Participant data file:2023Ethic form: 2023
empty
فایل داده شرکت کنندگان:1402فرم رضایت آگاهانه: 1402
فایل داده شرکت کنندگان:1402فرم رضایت آگاهانه: 1402
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Participant data file: Researcher & Patient Ethic form: Patient
Participant data file: Researcher & Patient Ethic form: Patient
empty
فایل داده شرکت کنندگان: محققین و بیمار فرم رضایت آگاهانه: بیمار
فایل داده شرکت کنندگان: محققین و بیمار فرم رضایت آگاهانه: بیمار
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Participant data file: participant's or legal guardian's are permitted for awareness of the results. Ethic form: participant's or legal guardian's are permitted for awareness of the results.
Participant data file: participant's or legal guardian's are permitted for awareness of the results. Ethic form: participant's or legal guardian's are permitted for awareness of the results.
empty
فایل داده شرکت کنندگان: فرد شرکت کننده و یا قیم قانونی اجازه دارد از نتیجه مطلع گردد. فرم رضایت آگاهانه: فرد شرکت کننده و یا قیم قانونی اجازه دارد از نتیجه آزمایشات مطلع گردد.
فایل داده شرکت کنندگان: فرد شرکت کننده و یا قیم قانونی اجازه دارد از نتیجه مطلع گردد. فرم رضایت آگاهانه: فرد شرکت کننده و یا قیم قانونی اجازه دارد از نتیجه آزمایشات مطلع گردد.
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Participant data file: Obstetrics and gynecology ward Shiraz university of medical sciences Ethic form: Obstetrics and gynecology ward Shiraz university of medical sciences
Participant data file: Obstetrics and gynecology ward Shiraz university of medical sciences Ethic form: Obstetrics and gynecology ward Shiraz university of medical sciences
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فایل داده شرکت کنندگان: بخش زنان دانشگاه علوم پزشکی شیراز فرم رضایت آگاهانه: بخش زنان دانشگاه علوم پزشکی شیراز
فایل داده شرکت کنندگان: بخش زنان دانشگاه علوم پزشکی شیراز فرم رضایت آگاهانه: بخش زنان دانشگاه علوم پزشکی شیراز
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Participant data file: Refer to Maternal Fetal medicine Research Center, request for result information. Ethic form: Refer to Maternal Fetal medicine Research Center, request for result information.
Participant data file: Refer to Maternal Fetal medicine Research Center, request for result information. Ethic form: Refer to Maternal Fetal medicine Research Center, request for result information.
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فایل داده شرکت کنندگان: مراجعه به مرکز تحقیقات بیماریهای مادر و جنین؛ درخواست در اختیار قرار دادن اطلاعات فرم رضایت آگاهانه: مراجعه به مرکز تحقیقات بیماریهای مادر و جنین؛ درخواست در اختیار قرار دادن اطلاعات
فایل داده شرکت کنندگان: مراجعه به مرکز تحقیقات بیماریهای مادر و جنین؛ درخواست در اختیار قرار دادن اطلاعات فرم رضایت آگاهانه: مراجعه به مرکز تحقیقات بیماریهای مادر و جنین؛ درخواست در اختیار قرار دادن اطلاعات
Background:
Preterm labor and birth are associated with several neonatal complications including respiratory distress syndrome and intraventricular hemorrhage. Differentiating true and false labor pain is a dilemma to obstetricians.
Objective:
To elucidate the role of cervical length measurement in prediction of birth in pregnant women with threatened preterm labor.
Materials and Methods:
In this double blind randomized clinical trial, 120 women with gestational age <34 wk who presented painful uterine contractions randomly assigned to undergo measurement of cervical length. Patients were registered in the hospital and a unit number was given. Based on the unit numbers, patients were randomly assigned to two groups using a computerized random digit generator. All participants were managed accordingly (n=65) or to receive tocolysis as planned (n=55). Tocolysis was prescribed when cervical length was <15 mm while those with cervical length ≥15 mm were managed expectantly. Delivery within 7 days of the presentation was the primary outcome.
Results:
This RCT showed in case group, 78.9% of patient with cervical length <15 mm were delivered within 7 days and only 21.1% of them maintained their pregnancy. Of those with cervical length ≥15 mm, only 15.2% were delivered within the study period and the rest (84.8%) maintained their pregnancy (p<0.001).
Conclusion:
“Our results indicate that in women who presented preterm labor symptoms, cervical length measurement will result in decreased unnecessary tocolytic treatment. Women with cervical length ≥15mm should not receive tocolysis, however, withholding corticosteroid therapy in these patients needs further evidence.
Background: Preterm labor and birth are associated with several neonatal complications including respiratory distress syndrome and intraventricular hemorrhage. Differentiating true and false labor pain is a dilemma to obstetricians. Objective: To elucidate the role of cervical length measurement in prediction of birth in pregnant women with threatened preterm labor. Materials and Methods: In this double blind randomized clinical trial, 120 women with gestational age <34 wk who presented painful uterine contractions randomly assigned to undergo measurement of cervical length. Patients were registered in the hospital and a unit number was given. Based on the unit numbers, patients were randomly assigned to two groups using a computerized random digit generator. All participants were managed accordingly (n=65) or to receive tocolysis as planned (n=55). Tocolysis was prescribed when cervical length was <15 mm while those with cervical length ≥15 mm were managed expectantly. Delivery within 7 days of the presentation was the primary outcome. Results: This RCT showed in case group, 78.9% of patient with cervical length <15 mm were delivered within 7 days and only 21.1% of them maintained their pregnancy. Of those with cervical length ≥15 mm, only 15.2% were delivered within the study period and the rest (84.8%) maintained their pregnancy (p<0.001). Conclusion: “Our results indicate that in women who presented preterm labor symptoms, cervical length measurement will result in decreased unnecessary tocolytic treatment. Women with cervical length ≥15mm should not receive tocolysis, however, withholding corticosteroid therapy in these patients needs further evidence.
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مقدمه: زایمان پرهترم، عوارض نوزادی متعددی از جمله سندرم دیسترس تنفسی نوزاد، خونریزی داخل بطنهای مغزی نوزاد همراه میباشد. تمایز زایمان پرهترم واقعی از دردهای کاذب زایمانی از موارد قابل بحث مهم در علم مامایی میباشد.
هدف: این مطالعه به منظور روشن ساختن نقش اندازهگیری طول دهانه رحم به وسیله سونوگرافی در پیشبینی زایمان زودرس در بیماران با درد زودرس زایمان میباشد.
موارد و روشها: این مطالعه به صورت کارآزمایی بالینی با توزیع تصادفی نمونهها در بیمارستانهای آموزشی درمانی حافظ وابسته به دانشگاه علوم پزشکی شیراز انجام شد. در این مطالعه 120 زن مراجعه کننده با انقباضات دردناک رحمی و سن حاملگی کمتر از 34 هفته به صورت تصادفی انتخاب شدند. به منظور تعیین دریافت توکولیکتیک سونوگرافی طول دهانه رحم در 65 نفر انجام شد. در بیمارانی که طول دهانه رحم آنها بیش از 15 میلیمتر بود به صورت انتظاری درمان شدند. زایمان در طی 7 روز بعد از بروز آنها به عنوان هدف نهایی مطالعه در نظر گرفته شد.
نتایج: اختلاف معنیداری بین دو گروه در اطلاعات پایه مثل سن وجود نداشت. از بین 19 بیمار (3/29%)، که طول دهانه رحم کمتر از 15 میلیمتر داشتند (9/78%) یعنی 15 نفر در طی 7 روز زایمان کردند و فقط (1/21%) یعنی 4 نفر زایمان نکردند و در بیمارانی که طول دهانه رحم بیشتر از 15 میلیمتر داشتند فقط (2/15%) یعنی 7 نفر در طی 7 روز زایمان کردند و بقیه آنها زایمان نکردند (8/84%) (001/0>p).
نتیجه گیری: اندازهگیری طول دهانه رحم در بیماران دردهای زودرس زایمانی باعث کاهش درمان غیر ضروری توکولیکتیک خواهد شد. بیماران با طول دهانه رحم بیش از 15 میلیمتر نباید توکلیتیک دریافت کنند. اگر چه ندادن کورتیکوستروئید در این بیماران به شواهد بیشتری احتیاج دارد.
مقدمه: زایمان پرهترم، عوارض نوزادی متعددی از جمله سندرم دیسترس تنفسی نوزاد، خونریزی داخل بطنهای مغزی نوزاد همراه میباشد. تمایز زایمان پرهترم واقعی از دردهای کاذب زایمانی از موارد قابل بحث مهم در علم مامایی میباشد. هدف: این مطالعه به منظور روشن ساختن نقش اندازهگیری طول دهانه رحم به وسیله سونوگرافی در پیشبینی زایمان زودرس در بیماران با درد زودرس زایمان میباشد. موارد و روشها: این مطالعه به صورت کارآزمایی بالینی با توزیع تصادفی نمونهها در بیمارستانهای آموزشی درمانی حافظ وابسته به دانشگاه علوم پزشکی شیراز انجام شد. در این مطالعه 120 زن مراجعه کننده با انقباضات دردناک رحمی و سن حاملگی کمتر از 34 هفته به صورت تصادفی انتخاب شدند. به منظور تعیین دریافت توکولیکتیک سونوگرافی طول دهانه رحم در 65 نفر انجام شد. در بیمارانی که طول دهانه رحم آنها بیش از 15 میلیمتر بود به صورت انتظاری درمان شدند. زایمان در طی 7 روز بعد از بروز آنها به عنوان هدف نهایی مطالعه در نظر گرفته شد. نتایج: اختلاف معنیداری بین دو گروه در اطلاعات پایه مثل سن وجود نداشت. از بین 19 بیمار (3/29%)، که طول دهانه رحم کمتر از 15 میلیمتر داشتند (9/78%) یعنی 15 نفر در طی 7 روز زایمان کردند و فقط (1/21%) یعنی 4 نفر زایمان نکردند و در بیمارانی که طول دهانه رحم بیشتر از 15 میلیمتر داشتند فقط (2/15%) یعنی 7 نفر در طی 7 روز زایمان کردند و بقیه آنها زایمان نکردند (8/84%) (001/0>p). نتیجه گیری: اندازهگیری طول دهانه رحم در بیماران دردهای زودرس زایمانی باعث کاهش درمان غیر ضروری توکولیکتیک خواهد شد. بیماران با طول دهانه رحم بیش از 15 میلیمتر نباید توکلیتیک دریافت کنند. اگر چه ندادن کورتیکوستروئید در این بیماران به شواهد بیشتری احتیاج دارد.
Protocol summary
Study aim
This study to elucidate the role of cervical length measurement in prediction of preterm birth in those with threatened preterm labor.
Design
We included 120 women presenting with painful uterine contractions before 34 weeks of gestation randomly assigned to undergo measurement of cervical length (n=65) and to receive tocolysis. Those with cervical length <15 mm received tocolysis. However those with cervical length ≥15 mm were managed expectantly. Delivery within 7 days of presentation was the primary outcome.
Settings and conduct
this study to elucidate the role of cervical length measurement in prediction of preterm birth in those with threatened preterm labor. This was a randomized clinical trial being performed at Hafez Hospital of Shiraz University of Medical Sciences. We included 120 women presenting with painful uterine contractions before 34 weeks of gestation randomly assigned to undergo measurement of cervical length (n=65) and to receive tocolysis. Those with cervical length <15 mm received tocolysis. However those with cervical length ≥15 mm were managed expectantly. Delivery within 7 days of presentation was the primary outcome.
Participants/Inclusion and exclusion criteria
Women with cervical dilatation >5 cm, polyhydramnios, macrosomia, multiple pregnancy, suspected intrauterine infection, rupture of membranes, vaginal bleeding were excluded.
Intervention groups
65 patients undergoing cervical length measurement by transvaginal
ultrasonography for further management (case group) and 55 patients who received tocolytic and corticosteroid therapy (control group)
Main outcome variables
cervical length, Delivery within 7 days
General information
Reason for update
Add results and modify some items
Acronym
IRCT registration information
IRCT registration number:IRCT2017092317034N5
Registration date:2017-10-16, 1396/07/24
Registration timing:retrospective
Last update:2023-12-06, 1402/09/15
Update count:1
Registration date
2017-10-16, 1396/07/24
Registrant information
Name
Homeira Vafaei Cisakht
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
vafaeih@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2010-10-01, 1389/07/09
Expected recruitment end date
2015-02-01, 1393/11/12
Actual recruitment start date
2010-10-01, 1389/07/09
Actual recruitment end date
2015-02-01, 1393/11/12
Trial completion date
2015-02-01, 1393/11/12
Scientific title
Targeted therapy for threatened preterm labor based on sonographic measurements of the cervical length in women
Public title
Cervical length measurement for preterm labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 4 contractions in 20 min interval
Single pregnancy
Gestational age before 34 weeks
Maternal age 18-40 y
Exclusion criteria:
Polyhydramnios (amniotic fluid index greater than 24 cm)
Macrosomia(estimated fetal weight >90th centile)
Rupture of membranes
Cervical dilatation >5 cm
Multiple pregnancy
Suspected intrauterine infection
Vaginal bleeding (more than bloody show)
Major medical disorders in mother
Contraindicated for vaginal delivery(e.g. placenta previa)
Non-reassuring fetal heart monitoring
Fetal anomaly
Any contraindication for administer of beta-sympathomimetic drugs and previous treatment with tocolytics/corticosteroid in this pregnancy
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the unit numbers, patients were randomly assigned to two groups using a computerized random digit generator.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will receive A medication based on computerized random digit number in double blind method and a code will be allocated to each patient (1 to 120) that will be encoded at the end of the study. The patients and the designer and drug distributors are not aware of the drug pack. This study is the second phase of trial.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences، Zand Street، Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Approval date
2010-03-18, 1388/12/27
Ethics committee reference number
Ct-88-5026
Health conditions studied
1
Description of health condition studied
Threatened preterm labor
ICD-10 code
o60
ICD-10 code description
Preterm labour and delivery
Primary outcomes
1
Description
Transvaginal sonography
Timepoint
At the beginning of the enrollment and after persistent uterine contractions more than 4 hours
Method of measurement
Sonography
2
Description
Preterm birth
Timepoint
7 days after enrollment
Method of measurement
Delivery
Secondary outcomes
empty
Intervention groups
1
Description
Those who were assigned to the case group underwent transvaginal ultrasonography for measuring the cervical length by one expert obstetrician. Neither residents nor sonographers were not aware of this clinical trial. Those with cervical length <15 mm were received tocolytic ( Nifedipne (tablet 10 mg manufactured by toliddaru Pharmaceutical Company ) 20 to 30 mg orally initial loading dose, then followed 10 mg every 6 hours up to 48 hours with a maximum dose of 180 mg/day) and corticosteroid therapy according to the hospital protocol. Expectantly management was performed when cervical length was ≥15 mm, but with persistent uterine contractions more than 4 hr, another cervical measurement was performed by the same operator. If the cervical length was become <15 mm tocolytic and antenatal corticosteroids were given.
Category
Treatment - Drugs
2
Description
In 55 patients that were diagnosed with preterm labor pain without check cervical length, tocolytic and antenatal corticosteroids were given.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Syedeh Marjan Hosseni
Street address
Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7184837786
Phone
+98 71 3647 9830
Email
hafez_perina@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3647 9830
Email
hashemib@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Marjan Hosseni
Position
Rezedent of Obstetrics & GYN
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shiraz University of Medical Sciences، Zand street
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+32 332365
Fax
Email
marjanhosseini2410@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Homeira Vafaei
Position
Professor of Obstetrics & GYN
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shiraz University of Medical Science, Zand Street
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3233 2365
Fax
Email
vafaeih@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr. Seydeh Marjan Hosseni
Position
Professor of Obstetrics & GYN
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shiraz University of Medical Science , Zand Street
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3233 2365
Fax
Email
hafez_perina@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Participant data file: Information and research data Ethic form: Complete the ٍEthic form by the patient
When the data will become available and for how long
Participant data file:2023Ethic form: 2023
To whom data/document is available
Participant data file: Researcher & Patient Ethic form: Patient
Under which criteria data/document could be used
Participant data file: participant's or legal guardian's are permitted for awareness of the results. Ethic form: participant's or legal guardian's are permitted for awareness of the results.
From where data/document is obtainable
Participant data file: Obstetrics and gynecology ward Shiraz university of medical sciences Ethic form: Obstetrics and gynecology ward Shiraz university of medical sciences
What processes are involved for a request to access data/document
Participant data file: Refer to Maternal Fetal medicine Research Center, request for result information. Ethic form: Refer to Maternal Fetal medicine Research Center, request for result information.
Comments
Trial results
Please tick if results have been published
Yes
Summary result posting date
2023-12-06, 1402/09/15
Table of baseline comparison
Participant flow diagram
Table of variable outcomes' results
Table of adverse events
First publication date
2017-11-01, 1396/08/10
Abstract of published paper
Background:
Preterm labor and birth are associated with several neonatal complications including respiratory distress syndrome and intraventricular hemorrhage. Differentiating true and false labor pain is a dilemma to obstetricians.
Objective:
To elucidate the role of cervical length measurement in prediction of birth in pregnant women with threatened preterm labor.
Materials and Methods:
In this double blind randomized clinical trial, 120 women with gestational age <34 wk who presented painful uterine contractions randomly assigned to undergo measurement of cervical length. Patients were registered in the hospital and a unit number was given. Based on the unit numbers, patients were randomly assigned to two groups using a computerized random digit generator. All participants were managed accordingly (n=65) or to receive tocolysis as planned (n=55). Tocolysis was prescribed when cervical length was <15 mm while those with cervical length ≥15 mm were managed expectantly. Delivery within 7 days of the presentation was the primary outcome.
Results:
This RCT showed in case group, 78.9% of patient with cervical length <15 mm were delivered within 7 days and only 21.1% of them maintained their pregnancy. Of those with cervical length ≥15 mm, only 15.2% were delivered within the study period and the rest (84.8%) maintained their pregnancy (p<0.001).
Conclusion:
“Our results indicate that in women who presented preterm labor symptoms, cervical length measurement will result in decreased unnecessary tocolytic treatment. Women with cervical length ≥15mm should not receive tocolysis, however, withholding corticosteroid therapy in these patients needs further evidence.