History
# Registration date Revision Id
3 2018-11-26, 1397/09/05 70828
2 2018-10-27, 1397/08/05 68234
1 2012-12-31, 1391/10/11 11090
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  • Protocol summary

    Objective: To determine the effects of oral glucose solution or maternal abdominal palpation on non stress test. Design: Experimental design with randomly assigned for one of two interventions: oral glucose solution or maternal abdominal palpation. The samples included 100 women who referring for prenatal care to Fathemieh hospital of Hamadan medical university in Iran. Setting: participants will be informed of the research aims and the reasons and methods of NST, then those participants who accepted to participate in the study were assisted by the researchers to complete the pregnancy information form. The participants with nonreactive NST will randomly assign to one of the two interventions (oral ingestion of 50g of glucose in 250ml of water or maternal abdominal palpation). NST will administrate after intervention, reactivity and time to reactivity will assess at the end of the 20 minutes and the results will be recorded. Inclusion criteria consist of: Maternal age ≤35 years; gestational age between 34 and 41 weeks(Novak & Brom 1999, Murray et al 2002); no smoking; no history of polyhidramnios, intrauterine growth retardation and multiple fetus complications ( Reeder et al. 1997; Oncken et al. 2002); no known congenital anomalies; no maternal medical or obstetric complications; no maternal use of narcotics, sedation and other drug. Intervention: All pregnant women will assess in the same conditions, such as same quiet room and semi recumbent position. Women with non reactive NST randomly assign for one of two interventions (oral ingestion of 50g of glucose in 250ml of water or maternal abdominal palpation such as Leopold maneuver), then 20 min monitoring will be done after intervention. Main outcome measures: The criteria of the effect for the intervention is fetal movement with the acceleration of fetal heart rate at least 15 bpm and 15 s in duration appear 20 min after oral glucose ingestion and immediately after abdominal palpation. The NST parameters included: time in minutes of minimum length of NST defined as reactive, number of fetal movements, large acceleration of fetal heart rate, basal fetal heart rate and variable decelerations. The criteria of reactive is two or more FHR accelerations of at least 15 bpm lasting at least 15 seconds in any 20 min period of NST.
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    هدف: تعيين اثر تجويز محلول قند خوراكي و تحريك لمسي شكم مادر بر آزمون بدون استرس جنين طراحي: اين تحقيق از نوع تجربي مي باشد كه در آن واحدهاي شركت كننده به طور تصادفي تحت مداخله تجويز قند خوراكي يا تحريك لمسي شكم مادر قرار مي گيرند. نمونه ها شامل 100 نفر از زنان باردار مراجعه كننده به بيمارستان فاطميه همدان جهت انجام مراقبتهاي دوران بارداري كه داراي تست بدون استرس غيرفعال باشند مي باشد. روش انجام: واحدهاي پژوهش ابتدا از اهداف و روش پژوهش آگاه خواهند شد و پس از تمايل ايشان جهت شركت در پژوهش، پرسشنامه مربوطه تكميل ميگردد، واحد هاي پژوهش جهت مداخله به صورت تصادفي به دو گروه تقسيم مي شوند، در يك گروه تجويز 50 گرم قند خوراكي در 250 سي سي مايع صورت مي گيرد و در گروه ديگر لمس شكم مادر در حد مانور لئوپولد انجام مي شود، پس از مداخله تست بدون استرس به مدت 20 دقيقه انجام مي شود و فعال بودن تست و زمان لازم جهت فعال شدن تست و پاسخ جنين مورد ارزيابي قرار مي گيرد. شرايط ورود به مطالعه: شامل سن مادر كمتر يا مساوي 35 سال؛ سن حاملگي بين 34 تا 41 هفته( نواك و بوروم 1999، موري و همكاران 2002)؛ عدم مصرف سيگار، عدم ابتلا به هيدرآمنيوس؛ مرگ داخل رحمي و حاملگي چندقلو( ريدر و همكاران 1997، اونكن و همكاران 2002)؛ عدم ابتلا جنين به ناهنجاري هاي مادرزادي شناخته شده؛ عدم ابتلا مادر به بيماري هاي طبي و مامايي؛ عدم استفاده از ناركوتيك ها، مخدرها يا ساير داروها توسط مادر. مداخلات:‌ همه واحدهاي پژوهش داراي تست بدون استرس غير فعال بوده و در شرايط يكسان مانند انجام آزمايش در اتاق ساكت و وضعيت نيمه نشسته بررسي مي شوند. واحدهاي پژوهش به صورت تصادفي به دو گروه مداخله تقسيم مي شوند( در يك گروه تجويز 50 گرم گلوكز در 250 سي سي آب و در گروه ديگر لمس شكم مادر در حد مانور لئوپولد صورت مي گيرد) و پس از مداخله حدود 20 دقيقه تحت آزمون بدون استرس جنين قرار مي گيرند. متغيرهاي پيامد اصلي: شاخص اثر مداخله ايجاد حركت جنين همراه با افزايش تعداد ضربان قلب جنين به تعداد حداقل 15 ضربه در دقيقه با طول 15 ثانيه، 20 دقيقه پس از تجويز محلول قند خوراكي و بلافاصله پس از لمس شكم مادر مي باشد. شاخص هاي آزمون تست بدون استرس شامل حداقل زمان لازم براي فعال شدن آزمون، تعداد حركات جنين، ميزان ضربان پايه قلب جنين و تعداد بيشترين افزايش در ضربان قلب مي باشد. شاخص فعال بودن تست بدون استرس شامل 2 يا بيشتر افزايش ضربان قلب جنين به تعداد حداقل 15 ضربه كه حداقل 15 ثانيه در يك دوره 20 دقيقه اي از آزمون بدون استرس طول بكشد.
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    Comparison of the effects of oral glucose solution or maternal abdominal palpation on non stress test.
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    مقایسه تاثير محلول قند خوراكي و تحريك لمسی جنين بر شاخص هاي آزمون بدون استرس جنين
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    A randomized clinical trial, with two intervention groups of 100 pregnant women, between November 2018 to September 2019.
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    کارآزمایی بالینی تصادفی شده، با دو گروه مداخله از 100 خانم باردار، بین آبان 1397 تا شهریور 1398.
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    At Fatemieh Hospital in Hamadan city, under the same conditions as the rest in a quiet room, left lateral position, and empty bladder, the research units after completion of the consent form, are randomly divided into two groups, in one group administration of 50g/250cc of water and in another group, the abdominal palpation of the mother (Leopold maneuver) is carried out in one or two times and the movements of the fetus are graded ( If there is no movement, zero score, if the mother feels the movements of the fetus, score 1, if the examiner feels the movements of the fetus score 2 and if the examiner sees the movements of the fetus score 3, then score 2 or 3 are selected). Non Stress Test for 20 minutes along with cardiac monitoring, movements and fetal heart rate is recorded.
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    در بیمارستان فاطمیه شهر همدان، در شرايط يكسان مانند انجام آزمايش در اتاق ساكت و وضعیت خوابيده به پهلوي چپ و تخلیه مثانه. واحدهاي پژوهش پس از تمايل و تكميل فرم رضايت نامه، به دو گروه تقسيم مي شوند، در يك گروه تجويز 50 گرم قند خوراكي در 250 سي سي آب صورت مي گيرد و در گروه ديگر لمس شكم مادر در حد مانور لئوپولد يك تا دو بار به فاصله 10 دقيقه انجام مي شود، پس از لمس شكم مادر حركات جنين بدين صورت درجه بندي مي شود ( اگر هيچگونه حركتي وجود نداشته باشد نمره صفر، اگر مادر حركات جنين را احساس نمايد نمره 1، اگر معاينه كننده حركات جنين را احساس نمايد نمره 2 و اگر معاينه كننده حركات جنين را مشاهده كند نمره 3 تعلق مي گيرد سپس در افرادي كه نمره 2 يا3 را كسب مي كنند انتخاب می شوند). تست بدون استرس به مدت 20 دقيقه با همراهي مانيتورينگ قلبي، تعداد حركات و تعداد ضربان قلب جنين ثبت مي گردد.
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    - Age 18 to 35 - Gestational age 34 to 41 weeks - Single pregnancy - No history of infertility - regular pregnancy care - Not any illness in pregnancy (diabetes, blood pressure and ...) - normal glucose tolerance test at 28-24 weeks of gestation - No smoking - No infection of Hydramnios, Intrauterine death and ... - No recognize congenital anomalies of the fetus - Not use narcotics, opiates or other drugs by the mother
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    -سن 18 تا 35 سال - سن بارداری 34 تا 41 هفته - حاملگی یک قلو - عدم سابقه نازایی - داشتن مراقبت بارداری بطور منظم - عدم وجود هر گونه بیماری در بارداری (دیابت، فشار خون و ...........) - داشتن تست تحمل گلوکز طبیعی در هفته 28-24 حاملگی - عدم مصرف سیگار - عدم ابتلا به هیدرآمنیوس، مرگ داخل رحمی و ... - عدم ابتلا جنین به ناهنجاری های مادرزادی شناخته شده - عدم استفاده از ناركوتيك ها، مخدرها يا ساير داروها توسط مادر
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    The research units were randomly divided into two groups, one group administered 50 grams of oral sugars in 250 cc of water and in the other group, the abdominal palpation of the Leopold maneuvered, one or two times with 10 minutes interval, is done.
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    واحد هاي پژوهش جهت مداخله به صورت تصادفي ساده به دو گروه تقسيم مي شوند، در يك گروه تجويز 50 گرم قند خوراكي در 250 سي سي آب صورت مي گيرد و در گروه ديگر لمس شكم مادر در حد مانور لئوپولد يك تا دو بار به فاصله 10 دقيقه انجام مي شود،
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    Fetal movement
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    حركت جنين
  • General information

    Age 18 to 35 years old
    Gestational age 34 to 41 weeks
    Single pregnancy
    Infertility failure
    Having regular pregnancy care
    The absence of any illness in pregnancy (diabetes, blood pressure and ...)
    Having a normal glucose tolerance test at 28-24 weeks of gestation
    No smoking
    No Hydramnios and Intrauterine death
    no recognize congenital anomalies of the fetus to
    Do not use narcotics, opiates or other drugs by the mother
    سن 18 تا 35 سال
    سن بارداری 34 تا 41 هفته
    حاملگی یک قلو
    عدم سابقه نازایی
    داشتن مراقبت بارداری بطور منظم
    عدم وجود هر گونه بیماری در بارداری (دیابت، فشار خون و ...........)
    داشتن تست تحمل گلوکز طبیعی در هفته 28-24 حاملگی-
    عدم مصرف سیگار
    عدم ابتلا به هیدرآمنیوس , مرگ داخل رحمی
    عدم ابتلا جنین به ناهنجاری های مادرزادی شناخته شده
    عدم استفاده از ناركوتيك ها، مخدرها يا ساير داروها توسط مادر
    abnormal fetal heart rate
    ضربان غیر طبیعی قلب جنین
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    Research units are randomly assigned to one of two study groups using random numbers and each group receives one of the relevant interventions.
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    واحدهای پژوهش به صورت تصادفی و با کمک جدول اعداد تصادفی در گروههای مطالعه قرار می گیرند و هر گروه یکی از مداخله های مربوطه را دریافت می کند.
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  • Ethics committees

    #1
    2012-07-07, 1391/04/17
    2018-10-13, 1397/07/21
    1280/9/35/16/پ/د
    IR.UMSHA.REC.1397.477
  • Health conditions studied

    #1
    O68.9
    Labour and delivery complicated by fetal stress, unspecified
  • Secondary outcomes

    #1
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    Increase fetal heart rate
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    افزایش ضربان قلب جنین
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    At the time of testing
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    در زمان انجام تست
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    Fetal heart ratemonitoring
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    مانیتورینگ قلب جنین
  • Intervention groups

    #1
    همه واحدهاي پژوهش داراي تست بدون استرس غير فعال بوده و در شرايط يكسان مانند انجام آزمايش در اتاق ساكت و وضعيت نيمه نشسته بررسي مي شوند. واحدهاي پژوهش به صورت تصادفي تحت تجويز 50 گرم گلوكز در 250 سي سي آب قرار گرفته و 30 دقيقه پس از مداخله، به مدت 20 دقيقه تحت آزمون بدون استرس جنين قرار مي گيرند.
    در شرايط يكسان مانند انجام آزمايش در اتاق ساكت و وضعيت نيمه نشسته بررسي مي شوند. واحدهاي پژوهش به صورت تصادفي تحت تجويز 50 گرم گلوكز در 250 سي سي آب قرار گرفته و 30 دقيقه پس از مداخله، به مدت 20 دقيقه تحت آزمون بدون استرس جنين قرار مي گيرند.
    #2
    همه واحدهاي پژوهش داراي تست بدون استرس غير فعال بوده و در شرايط يكسان مانند انجام آزمايش در اتاق ساكت و وضعيت نيمه نشسته بررسي مي شوند. لمس شكم مادر در حد مانور لئوپولد يك تا دو بار به فاصله 10 دقيقه انجام مي شود و بلافاصله پس از مداخله آزمون بدون استرس جنين به مدت 20 دقيقه انجام مي شود.
    همه واحدهاي پژوهش در شرايط يكسان مانند انجام آزمايش در اتاق ساكت و وضعيت نيمه نشسته بررسي مي شوند. لمس شكم مادر در حد مانور لئوپولد يك تا دو بار به فاصله 10 دقيقه انجام مي شود و بلافاصله پس از مداخله آزمون بدون استرس جنين به مدت 20 دقيقه انجام مي شود.
  • Recruitment centers

    #1
    Name of recruitment center - English: Hamadan Fathemieh Hospital
    Name of recruitment center - Persian: بيمارستان فاطميه همدان
    Full name of responsible person - English: Aghababaei Soodabeh
    Full name of responsible person - Persian: سودابه آقابابايي
    Street address - English: Nursing & Midwifery Faculty; Hamadan Medical university; Shahid Fahmideh Ave; Hamadan; Iran.
    Street address - Persian: همدان، دانشگاه علوم پزشكي، دانشكده پرستاري و مامايي
    City - English: Hamadan
    City - Persian: همدان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Hamadan Fathemieh Hospital
    Name of recruitment center - Persian: بيمارستان فاطميه همدان
    Full name of responsible person - English: Aghababaei Soodabeh
    Full name of responsible person - Persian: سودابه آقابابايي
    Street address - English: Nursing & Midwifery Faculty; Hamadan Medical university; Shahid Fahmideh Ave; Hamadan; Iran.
    Street address - Persian: همدان، دانشگاه علوم پزشكي، دانشكده پرستاري و مامايي
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 65187
    Phone: +98 81 3838 0150
    Fax:
    Email: aghababaii@yahoo.com
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice Chancellor for Research and Thecnology Research, Hamadan university of Medical Sciences
    Name of organization / entity - Persian: معاونت تحقيقات و فناوري دانشگاه علوم پزشكي همدان
    Full name of responsible person - English: Dr Haidar Tavilani
    Full name of responsible person - Persian: دكتر حيدر طويلاني
    Street address - English: Vice Chancellor for Research and Thecnology Research; Hamadan Medical university; Shahid Fahmideh Ave; Hamadan; Iran.
    Street address - Persian: همدان - بلوار شهيد فهميده - دانشگاه علوم پزشكي همدان - معاونت تحقيقات و فناوري
    City - English: Hamadan
    City - Persian: همدان
    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 and Thecnology Research, Hamadan university of Medical Sciences
    Name of organization / entity - Persian: معاونت تحقيقات و فناوري دانشگاه علوم پزشكي همدان
    Full name of responsible person - English: Dr Said Bashirian
    Full name of responsible person - Persian: دكتر سعید بشیریان
    Street address - English: Vice Chancellor for Research and Thecnology Research; Hamadan Medical university; Shahid Fahmideh Ave; Hamadan; Iran.
    Street address - Persian: همدان - بلوار شهيد فهميده - دانشگاه علوم پزشكي همدان - معاونت تحقيقات و فناوري
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 65187
    Phone: +98 81 3838 0717
    Fax: +98 81 3838 0130
    Email: info.research@umsha.ac.ir
    Web page address:
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    Public
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    Domestic
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    Academic
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Nursing & Midwifery Faculty; Hamadan Medical university of Iran.
    Name of organization / entity - Persian: دانشگاه علوم پزشكي همدان، دانشكده پرستاري و مامايي
    Full name of responsible person - English: Aghababaei Soodabeh
    Full name of responsible person - Persian: سودابه آقابابايي
    Position - English: Academic member, Master of sciences
    Position - Persian: كارشناسي ارشد، مربي( عضو هيئت علمي)
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nursing & Midwifery Faculty; Hamadan Medical university; Shahid Fahmideh Ave; Hamadan; Iran.
    Street address - Persian: ايران، همدان، خيابان شهيد فهميده، دانشگاه علوم پزشكي همدان، دانشكده پرستاري و مامايي
    City - English: Hamadan
    City - Persian: همدان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 81 1824 1716
    Mobile: +98 918 316 4291
    Fax:
    Email: aghababaei@umsha.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Nursing & Midwifery Faculty; Hamadan Medical university of Iran.
    Name of organization / entity - Persian: دانشگاه علوم پزشكي همدان، دانشكده پرستاري و مامايي
    Full name of responsible person - English: Aghababaei Soodabeh
    Full name of responsible person - Persian: سودابه آقابابايي
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 1
    Area of specialty/work title - English: بهداشت باروری
    Area of specialty/work title - Persian: Reproductive Health
    Street address - English: Nursing & Midwifery Faculty; Hamadan Medical university; Shahid Fahmideh Ave; Hamadan; Iran.
    Street address - Persian: ايران، همدان، خيابان شهيد فهميده، دانشگاه علوم پزشكي همدان، دانشكده پرستاري و مامايي
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 38698-65178
    Phone: +98 81 3838 0535
    Mobile: +98 918 316 4291
    Fax: +98 81 3838 0447
    Email: aghababaii@yahoo.com
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Hamadan Medical university of Iran
    Name of organization / entity - Persian: دانشگاه علوم پزشكي همدان
    Full name of responsible person - English: Aghababaei Soodabeh
    Full name of responsible person - Persian: سودابه اقابابايي
    Position - English: Academic member M. S
    Position - Persian: مربي، عضو هيئت علمي
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nursing & Midwifery Faculty; Hamadan Medical university; Shahid Fahmideh Ave; Hamadan; Iran.
    Street address - Persian: همدان،‌دانشگاه علوم پزشكي، دانشكده پرستاري و مامايي و دانشكده پزشكي
    City - English: Hamadan
    City - Persian: همدان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 81 1824 1716
    Mobile: +98 31 64291
    Fax:
    Email: aghababaei@umsha.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Hamadan Medical university of Iran
    Name of organization / entity - Persian: دانشگاه علوم پزشكي همدان
    Full name of responsible person - English: Aghababaei Soodabeh
    Full name of responsible person - Persian: سودابه اقابابايي
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 1
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nursing & Midwifery Faculty; Hamadan Medical university; Shahid Fahmideh Ave; Hamadan; Iran.
    Street address - Persian: همدان،‌دانشگاه علوم پزشكي، دانشكده پرستاري و مامايي و دانشكده پزشكي
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 38698-65178
    Phone: +98 81 3838 0535
    Mobile: +98 918 316 4291
    Fax: +98 81 3838 0447
    Email: aghababaei@umsha.ac.ir
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Hamadan Medical university of Iran
    Name of organization / entity - Persian: دانشگاه علوم پزشكي همدان
    Full name of responsible person - English: Soodabeh Aghababaei
    Full name of responsible person - Persian: سودابه آقابابايي
    Position - English: Academic member, Master of sciences
    Position - Persian: مربي، عضو هيئت علمي
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nursing & Midwifery Faculty; Hamadan Medical university; Shahid Fahmideh Ave; Hamadan; Iran.
    Street address - Persian: همدان، بلوار شهيد فهميده، روبروي پارك مردم، دانشكده پرستاري و مامايي
    City - English: Hamadan
    City - Persian: همدان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 81 1824 1716
    Mobile: +98 918 316 4291
    Fax:
    Email: aghababaei@umsha.ac.ir
    Web page address: aghababaii@yahoo.com
    contact.organization_id:
    Name of organization / entity - English: Hamadan Medical university of Iran
    Name of organization / entity - Persian: دانشگاه علوم پزشكي همدان
    Full name of responsible person - English: Soodabeh Aghababaei
    Full name of responsible person - Persian: سودابه آقابابايي
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 1
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nursing & Midwifery Faculty; Hamadan Medical university; Shahid Fahmideh Ave; Hamadan; Iran.
    Street address - Persian: همدان، بلوار شهيد فهميده، روبروي پارك مردم، دانشكده پرستاري و مامايي
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 38698-65178
    Phone: +98 81 3838 0535
    Mobile: +98 918 316 4291
    Fax: +98 81 3838 0447
    Email: aghababaei@umsha.ac.ir
    Web page address:
  • Sharing plan

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Protocol summary

Study aim
Comparison of the effects of oral glucose solution or maternal abdominal palpation on non stress test.
Design
A randomized clinical trial, with two intervention groups of 100 pregnant women, between November 2018 to September 2019.
Settings and conduct
At Fatemieh Hospital in Hamadan city, under the same conditions as the rest in a quiet room, left lateral position, and empty bladder, the research units after completion of the consent form, are randomly divided into two groups, in one group administration of 50g/250cc of water and in another group, the abdominal palpation of the mother (Leopold maneuver) is carried out in one or two times and the movements of the fetus are graded ( If there is no movement, zero score, if the mother feels the movements of the fetus, score 1, if the examiner feels the movements of the fetus score 2 and if the examiner sees the movements of the fetus score 3, then score 2 or 3 are selected). Non Stress Test for 20 minutes along with cardiac monitoring, movements and fetal heart rate is recorded.
Participants/Inclusion and exclusion criteria
- Age 18 to 35 - Gestational age 34 to 41 weeks - Single pregnancy - No history of infertility - regular pregnancy care - Not any illness in pregnancy (diabetes, blood pressure and ...) - normal glucose tolerance test at 28-24 weeks of gestation - No smoking - No infection of Hydramnios, Intrauterine death and ... - No recognize congenital anomalies of the fetus - Not use narcotics, opiates or other drugs by the mother
Intervention groups
The research units were randomly divided into two groups, one group administered 50 grams of oral sugars in 250 cc of water and in the other group, the abdominal palpation of the Leopold maneuvered, one or two times with 10 minutes interval, is done.
Main outcome variables
Fetal movement

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2012082110635N1
Registration date: 2012-12-31, 1391/10/11
Registration timing: prospective

Last update: 2018-11-25, 1397/09/04
Update count: 2
Registration date
2012-12-31, 1391/10/11
Registrant information
Name
Soodabeh Aghababaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
aghababaii@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and Technology Research, Hamadan medical university of Iran.
Expected recruitment start date
2013-02-28, 1391/12/10
Expected recruitment end date
2013-12-28, 1392/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of oral glucose solution & maternal abdominal palpation effect on fetal non stress test.
Public title
Assessment of oral glucose solution & maternal abdominal palpation effect on fetal non stress test.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 35 years old Gestational age 34 to 41 weeks Single pregnancy Infertility failure Having regular pregnancy care The absence of any illness in pregnancy (diabetes, blood pressure and ...) Having a normal glucose tolerance test at 28-24 weeks of gestation No smoking No Hydramnios and Intrauterine death no recognize congenital anomalies of the fetus to Do not use narcotics, opiates or other drugs by the mother
Exclusion criteria:
abnormal fetal heart rate
Age
To 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Research units are randomly assigned to one of two study groups using random numbers and each group receives one of the relevant interventions.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamadan Medical university of Iran
Street address
Hamadan Medical university; Shahid Fahmideh Ave; Hamadan; Iran.
City
Hamadan
Province
Hamadan
Postal code
65178
Approval date
2018-10-13, 1397/07/21
Ethics committee reference number
IR.UMSHA.REC.1397.477

Health conditions studied

1

Description of health condition studied
Non Stress Test
ICD-10 code
O68.9
ICD-10 code description
Labour and delivery complicated by fetal stress, unspecified

Primary outcomes

1

Description
fetal movement
Timepoint
20 minutes after ingestion of 50g of glucose in 250ml of water or Immediately after maternal abdominal palpation.
Method of measurement
fetal non stress test

2

Description
Fetal heart rate
Timepoint
20 minutes after ingestion of 50g of glucose in 250ml of water or Immediately after maternal abdominal palpation.
Method of measurement
fetal non stress test

Secondary outcomes

1

Description
Increase fetal heart rate
Timepoint
At the time of testing
Method of measurement
Fetal heart ratemonitoring

Intervention groups

1

Description
All pregnant women will assess in the same conditions, such as same quiet room and semi recumbent position. Women with non reactive NST randomly assign for oral ingestion of 50g of glucose in 250ml of water, then 20 min monitoring will be done after 30 min of intervention.
Category
Diagnosis

2

Description
All pregnant women will assess in the same conditions, such as same quiet room and semi recumbent position. Women with non reactive NST randomly selected for 1 or 2 times abdominal palpation such as Leopold maneuver with 10 min interval, then 20 min monitoring will be done immediately after intervention.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamadan Fathemieh Hospital
Full name of responsible person
Aghababaei Soodabeh
Street address
Nursing & Midwifery Faculty; Hamadan Medical university; Shahid Fahmideh Ave; Hamadan; Iran.
City
Hamadan
Province
Hamadan
Postal code
65187
Phone
+98 81 3838 0150
Email
aghababaii@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Thecnology Research, Hamadan university of Medical Sciences
Full name of responsible person
Dr Said Bashirian
Street address
Vice Chancellor for Research and Thecnology Research; Hamadan Medical university; Shahid Fahmideh Ave; Hamadan; Iran.
City
Hamadan
Province
Hamadan
Postal code
65187
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
info.research@umsha.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 and Thecnology Research, Hamadan 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
Nursing & Midwifery Faculty; Hamadan Medical university of Iran.
Full name of responsible person
Aghababaei Soodabeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
بهداشت باروری
Street address
Nursing & Midwifery Faculty; Hamadan Medical university; Shahid Fahmideh Ave; Hamadan; Iran.
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
aghababaii@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan Medical university of Iran
Full name of responsible person
Aghababaei Soodabeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing & Midwifery Faculty; Hamadan Medical university; Shahid Fahmideh Ave; Hamadan; Iran.
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
aghababaei@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan Medical university of Iran
Full name of responsible person
Soodabeh Aghababaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing & Midwifery Faculty; Hamadan Medical university; Shahid Fahmideh Ave; Hamadan; Iran.
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
aghababaei@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document
-
Comments
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