Comparison of the Effectiveness of management of labor and delivery with using training on evidence-based cares based on the world health organization safe childbirth checklist and routine performance on maternal and neonatal outcomes
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Protocol summary
This study will be a matched pair, cluster-randomized controlled trial across eligible governmental hospitals in Ahvaz. four eligible hospitals will be identified. We will match hospitals (i.e. clusters) according being educational or not so that We will have an educational hospital and a non- educational hospital in each cluster.
Due to the fact that randomization will be performed on the basis of hospitals, not individually, the women admitted in each of these hospitals will be assigned to only one intervention group. Sampling of pregnant women will be done in convenience non -probability. All eligible women will select as a subject and this will be continued until we can gain the final sample size in each center.
This study will be Stratified randomized controlled trial across eligible governmental hospitals in Ahvaz. four eligible hospitals will be identified. We will match hospitals (i.e. strata) according being educational or not so that We will have an educational hospital and a non- educational hospital in each strata.
Due to the fact that randomization will be performed on the basis of hospitals, not individually, the women admitted in each of these hospitals will be assigned to only one intervention group. Sampling of pregnant women will be done in convenience non -probability. All eligible women will select as a subject and this will be continued until we can gain the final sample size in each center.
This study will be a matched pair, cluster-Stratified randomized controlled trial across eligible governmental hospitals in Ahvaz. four eligible hospitals will be identified. We will match hospitals (i.e. clustersstrata) according being educational or not so that We will have an educational hospital and a non- educational hospital in each clusterstrata. Due to the fact that randomization will be performed on the basis of hospitals, not individually, the women admitted in each of these hospitals will be assigned to only one intervention group. Sampling of pregnant women will be done in convenience non -probability. All eligible women will select as a subject and this will be continued until we can gain the final sample size in each center.
این مطالعه به صورت کارآزمایی بالینی خوشه ای همسان سازی شده در بیمارستان های دولتی دارای شرایط اهواز انجام خواهد شد.چهار بیمارستان دارای شرایط مشخص می گردند. ما بیمارستان ها (یعنی خوشه ها ) را بر اساس آموزشی بودن یا نبودن جفت خواهیم کرد، به طوری که در هر خوشه یک بیمارستان آموزشی و یک بیمارستان غیر آموزشی خواهیم داشت. با توجه به این واقعیت که رندوم سازی بر اساس نوع بیمارستان صورت خواهد گرفت نه به صورت شخصی، هر زن باردار بسته به نوع بیمارستانی که بستری خواهد شد، مراقبت اختصاص یافته به آن بیمارستان را دریافت خواهد کرد.نمونه گیری زنان بارداربه روش غیر احتمالی در دسترس صورت خواهد گرفت.کلیه زنان باردارواجد شرایط به عنوان نمونه انتخاب و این کار تا رسیدن به حجم نمونه نهایی در هرمرکز ادامه خواهد یافت.
این مطالعه به صورت کارآزمایی بالینی طبقه بندی شده تصادفی شده در بیمارستان های دولتی دارای شرایط اهواز انجام خواهد شد.چهار بیمارستان دارای شرایط مشخص می گردند. ما بیمارستان ها (یعنی طبقه ها ) را بر اساس آموزشی بودن یا نبودن انتخاب خواهیم کرد، به طوری که در هر طبقه یک بیمارستان آموزشی و یک بیمارستان غیر آموزشی خواهیم داشت. با توجه به این واقعیت که رندوم سازی بر اساس نوع بیمارستان صورت خواهد گرفت نه به صورت شخصی، هر زن باردار بسته به نوع بیمارستانی که بستری خواهد شد، مراقبت اختصاص یافته به آن بیمارستان را دریافت خواهد کرد.نمونه گیری زنان بارداربه روش غیر احتمالی در دسترس صورت خواهد گرفت.کلیه زنان باردارواجد شرایط به عنوان نمونه انتخاب و این کار تا رسیدن به حجم نمونه نهایی در هرمرکز ادامه خواهد یافت.
این مطالعه به صورت کارآزمایی بالینی خوشه ای همسان سازیطبقه بندی شده تصادفی شده در بیمارستان های دولتی دارای شرایط اهواز انجام خواهد شد.چهار بیمارستان دارای شرایط مشخص می گردند. ما بیمارستان ها (یعنی خوشهطبقه ها ) را بر اساس آموزشی بودن یا نبودن جفتانتخاب خواهیم کرد، به طوری که در هر خوشهطبقه یک بیمارستان آموزشی و یک بیمارستان غیر آموزشی خواهیم داشت. با توجه به این واقعیت که رندوم سازی بر اساس نوع بیمارستان صورت خواهد گرفت نه به صورت شخصی، هر زن باردار بسته به نوع بیمارستانی که بستری خواهد شد، مراقبت اختصاص یافته به آن بیمارستان را دریافت خواهد کرد.نمونه گیری زنان بارداربه روش غیر احتمالی در دسترس صورت خواهد گرفت.کلیه زنان باردارواجد شرایط به عنوان نمونه انتخاب و این کار تا رسیدن به حجم نمونه نهایی در هرمرکز ادامه خواهد یافت.
Inclusion criteria:
All providers who will be trained on evidence-based cares in accordance with the Safe Childbirth Checklist.
singleton pregnant women with gestational age 28 weeks or over who are admitted for vaginal delivery
Inclusion criteria:
All providers who will be trained on evidence-based cares in accordance with the Safe Childbirth Checklist.
singleton pregnant women with gestational age 37 weeks or over who are admitted for vaginal delivery
Inclusion criteria: All providers who will be trained on evidence-based cares in accordance with the Safe Childbirth Checklist. singleton pregnant women with gestational age 2837 weeks or over who are admitted for vaginal delivery
شرایط ورود به مطالعه :
کلیه ارائه دهندگان مراقبت از مادران باردار که آموزش های مراقبت مبتنی بر شواهد بر اساس چک لیست زایمان ایمن را دیده اند.
خانم های باردار باتک قلو با سن بارداری 28 هفته و بالاتر که جهت زایمان طبیعی بستری شده اند.
شرایط ورود به مطالعه :
کلیه ارائه دهندگان مراقبت از مادران باردار که آموزش های مراقبت مبتنی بر شواهد بر اساس چک لیست زایمان ایمن را دیده اند.
خانم های باردار باتک قلو با سن بارداری 37 هفته و بالاتر که جهت زایمان طبیعی بستری شده اند.
شرایط ورود به مطالعه : کلیه ارائه دهندگان مراقبت از مادران باردار که آموزش های مراقبت مبتنی بر شواهد بر اساس چک لیست زایمان ایمن را دیده اند. خانم های باردار باتک قلو با سن بارداری 2837 هفته و بالاتر که جهت زایمان طبیعی بستری شده اند.
General information
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2022-06-06, 1401/03/16
2022-06-05, 1401/03/15
2022-06-0605 00:00:00
2022-09-07, 1401/06/16
2022-09-06, 1401/06/15
2022-09-0706 00:00:00
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2022-06-05, 1401/03/15
2022-06-05 00:00:00
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2022-12-06, 1401/09/15
2022-12-06 00:00:00
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2023-01-20, 1401/10/30
2023-01-20 00:00:00
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The type of sampling has been cluster randomized but it has the characteristics of stratified sampling and due to the low number of births in hospitals, it took six months instead of two months to reach the sample size.
The type of sampling has been cluster randomized but it has the characteristics of stratified sampling and due to the low number of births in hospitals, it took six months instead of two months to reach the sample size.
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نوع نمونه گیری خوشه ای ذکر شده درصورتی که مشخصات نمونه گیری طبقه بندی دارد و با توجه به آمار کم زایمان ها در بیمارستانها برای رسیدن به حجم نمونه مدت زمان جمع آوری اطلاعات به جای دو ماه شش ماه طول کشید
نوع نمونه گیری خوشه ای ذکر شده درصورتی که مشخصات نمونه گیری طبقه بندی دارد و با توجه به آمار کم زایمان ها در بیمارستانها برای رسیدن به حجم نمونه مدت زمان جمع آوری اطلاعات به جای دو ماه شش ماه طول کشید
This study will be a matched pair, cluster-randomized controlled trial across eligible governmental hospitals in Ahvaz. four eligible hospitals will be
identified. We will match hospitals (i.e. clusters) according being educational or not, so that We will have an educational hospital and a non- educational hospital in each cluster.
Due to the fact that randomization will be performed on the basis of hospitals, not individually, the women admitted in each of these hospitals will be assigned to only one intervention group. 236 eligible pregnant women will be enrolled in each of the hospitals and this will be continued until we can gain the final sample size in each center. Sampling of pregnant women will be done in convenience non -probability.
This study will be a Stratified randomized controlled trial across eligible governmental hospitals in Ahvaz. four eligible hospitals will be
identified. We will match hospitals (i.e.strata) according being educational or not, so that We will have an educational hospital and a non- educational hospital in each strata.
Due to the fact that randomization will be performed on the basis of hospitals, not individually, the women admitted in each of these hospitals will be assigned to only one intervention group. 236 eligible pregnant women will be enrolled in each of the hospitals and this will be continued until we can gain the final sample size in each center. Sampling of pregnant women will be done in convenience non -probability.
This study will be a matched pair, cluster-Stratified randomized controlled trial across eligible governmental hospitals in Ahvaz. four eligible hospitals will be identified. We will match hospitals (i.e. clustersi.e.strata) according being educational or not, so that We will have an educational hospital and a non- educational hospital in each clusterstrata. Due to the fact that randomization will be performed on the basis of hospitals, not individually, the women admitted in each of these hospitals will be assigned to only one intervention group. 236 eligible pregnant women will be enrolled in each of the hospitals and this will be continued until we can gain the final sample size in each center. Sampling of pregnant women will be done in convenience non -probability.
این مطالعه به صورت کارآزمایی بالینی خوشه ای همسان سازی شده در بیمارستان های دولتی دارای شرایط اهواز انجام خواهد شد. چهار بیمارستان دارای شرایط مشخص می گردند. ما
بیمارستان ها را بر اساس آموزشی بودن یا نبودن (خوشه ها) جفت خواهیم کرد ، به طوری که در هر خوشه یک بیمارستان آموزشی و یک بیمارستان غیر آموزشی خواهیم داشت. با در نظر گرفتن این واقعیت که رندوم سازی بر اساس نوع بیمارستان صورت خواهد گرفت نه به صورت شخصی ، هر زن باردار بسته به نوع بیمارستانی که بستری خواهد شد ، مراقبت اختصاص یافته به آن بیمارستان را دریافت خواهد کرد. تعداد 236 زن باردار واجد شرایط در هر یک از بیمارستان ها وارد مطالعه خواهند شد. بدین نحو که از زمان شروع مطالعه ،کلیه زنان باردارواجد شرایط به عنوان نمونه انتخاب و این کار تا رسیدن به حجم نمونه نهایی در هرمرکز ادامه خواهد یافت.نمونه گیری زنان باردار به روش غیر احتمالی در دسترس صورت خواهد گرفت.
این مطالعه به صورت کارآزمایی بالینی طبقه بندی شده تصادفی کنترل شده در بیمارستان های دولتی دارای شرایط اهواز انجام خواهد شد. چهار بیمارستان دارای شرایط مشخص می گردند. ما
بیمارستان ها را بر اساس آموزشی بودن یا نبودن (طبقه ها) انتخاب خواهیم کرد ، به طوری که در هر طبقه یک بیمارستان آموزشی و یک بیمارستان غیر آموزشی خواهیم داشت. با در نظر گرفتن این واقعیت که رندوم سازی بر اساس نوع بیمارستان صورت خواهد گرفت نه به صورت شخصی ، هر زن باردار بسته به نوع بیمارستانی که بستری خواهد شد ، مراقبت اختصاص یافته به آن بیمارستان را دریافت خواهد کرد. تعداد 236 زن باردار واجد شرایط در هر یک از بیمارستان ها وارد مطالعه خواهند شد. بدین نحو که از زمان شروع مطالعه ،کلیه زنان باردارواجد شرایط به عنوان نمونه انتخاب و این کار تا رسیدن به حجم نمونه نهایی در هرمرکز ادامه خواهد یافت.نمونه گیری زنان باردار به روش غیر احتمالی در دسترس صورت خواهد گرفت.
این مطالعه به صورت کارآزمایی بالینی خوشه ای همسان سازیطبقه بندی شده تصادفی کنترل شده در بیمارستان های دولتی دارای شرایط اهواز انجام خواهد شد. چهار بیمارستان دارای شرایط مشخص می گردند. ما بیمارستان ها را بر اساس آموزشی بودن یا نبودن (خوشهطبقه ها) جفتانتخاب خواهیم کرد ، به طوری که در هر خوشهطبقه یک بیمارستان آموزشی و یک بیمارستان غیر آموزشی خواهیم داشت. با در نظر گرفتن این واقعیت که رندوم سازی بر اساس نوع بیمارستان صورت خواهد گرفت نه به صورت شخصی ، هر زن باردار بسته به نوع بیمارستانی که بستری خواهد شد ، مراقبت اختصاص یافته به آن بیمارستان را دریافت خواهد کرد. تعداد 236 زن باردار واجد شرایط در هر یک از بیمارستان ها وارد مطالعه خواهند شد. بدین نحو که از زمان شروع مطالعه ،کلیه زنان باردارواجد شرایط به عنوان نمونه انتخاب و این کار تا رسیدن به حجم نمونه نهایی در هرمرکز ادامه خواهد یافت.نمونه گیری زنان باردار به روش غیر احتمالی در دسترس صورت خواهد گرفت.
Recruitment centers
#1
Name of recruitment center - English: Sina hospital karoon
Name of recruitment center - Persian: بیمارستان سینا شهرستان کارون
Full name of responsible person - English: Atefeh Kamrani
Full name of responsible person - Persian: عاطفه کامرانی
Street address - English: Sina hospital karoon khouzestan Iran khouzestan Islamic Republic Of Iran
Street address - Persian: خوزستان ، اهواز ، کوت عبدالله ، میدان امام علی(ع) ، خیابان پنجم گندمکار ، بیمارستان سینا اهواز وابسته به دانشگاه جندی شاپور اهواز خوزستان ایران
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 17111 61991
Phone: +98 61 3555 0592
Fax:
Email: sinahospital.ch@ajums.ac.ir
Web page address:
Name of recruitment center - English: Sina hospital karoon
Name of recruitment center - Persian: بیمارستان سینا شهرستان کارون
Full name of responsible person - English: Atefeh Kamrani
Full name of responsible person - Persian: عاطفه کامرانی
Street address - English: Sina hospital, 5th Gandomkar Ave, Imam Ali Square, Kut Abdullah
Street address - Persian: کوت عبدالله، میدان امام علی(ع)، خیابان پنجم گندمکار، بیمارستان سینا
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 17111 61991
Phone: +98 61 3555 0592
Fax:
Email: sinahospital.ch@ajums.ac.ir
Web page address:
Name of recruitment center - English: Sina hospital karoon Name of recruitment center - Persian: بیمارستان سینا شهرستان کارون Full name of responsible person - English: Atefeh Kamrani Full name of responsible person - Persian: عاطفه کامرانی Street address - English: Sina hospital karoon khouzestan Iran khouzestan Islamic Republic Of Iran, 5th Gandomkar Ave, Imam Ali Square, Kut Abdullah Street address - Persian: خوزستان ، اهواز ، کوت عبدالله، میدان امام علی(ع)، خیابان پنجم گندمکار، بیمارستان سینا اهواز وابسته به دانشگاه جندی شاپور اهواز خوزستان ایران City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 17111 61991 Phone: +98 61 3555 0592 Fax: Email: sinahospital.ch@ajums.ac.ir Web page address:
#2
Name of recruitment center - English: Imam khomeiney hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Atefeh Kamrani
Full name of responsible person - Persian: عاطفه کامرانی
Street address - English: Imam khomeiney hospital, Azadegan street, Ahvaz, Khouzestan
Street address - Persian: خوزستان ، اهواز ، خیابان آزادگان ، بیمارستان امام خمینی (ره)
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: ۶۱۹۳۶۷۳۱۶۶
Phone: +98 61 1222 2922
Fax:
Email: himam@ajums.ac.ir
Web page address: http://bankpezeshkan.co
Name of recruitment center - English: Imam khomeiney hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Atefeh Kamrani
Full name of responsible person - Persian: عاطفه کامرانی
Street address - English: Imam khomeiney hospital, Azadegan Blvd
Street address - Persian: بلوار آزادگان ، بیمارستان امام خمینی (ره)
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: ۶۱۹۳۶۷۳۱۶۶
Phone: +98 61 1222 2922
Fax:
Email: himam@ajums.ac.ir
Web page address: http://bankpezeshkan.co
Name of recruitment center - English: Imam khomeiney hospital Name of recruitment center - Persian: بیمارستان امام خمینی Full name of responsible person - English: Atefeh Kamrani Full name of responsible person - Persian: عاطفه کامرانی Street address - English: Imam khomeiney hospital, Azadegan street, Ahvaz, KhouzestanBlvd Street address - Persian: خوزستان ، اهواز ، خیابانبلوار آزادگان ، بیمارستان امام خمینی (ره) City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: ۶۱۹۳۶۷۳۱۶۶ Phone: +98 61 1222 2922 Fax: Email: himam@ajums.ac.ir Web page address: http://bankpezeshkan.co
#3
Name of recruitment center - English: Taleghani hospital
Name of recruitment center - Persian: بیمارستان طالقانی
Full name of responsible person - English: Atefeh Kamrani
Full name of responsible person - Persian: عاطفه کامرانی
Street address - English: Taleghani hospital, Padashahr phase2 , Ahvaz, Khouzestan
Street address - Persian: خوزستان ، اهواز ،فاز دو پادا شهر ، بیمارستان طالقانی
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 61339611151
Phone: +98 61 3554 0256
Fax:
Email: htaleghani@ajums.ac.ir
Web page address:
Name of recruitment center - English: Taleghani hospital
Name of recruitment center - Persian: بیمارستان طالقانی
Full name of responsible person - English: Atefeh Kamrani
Full name of responsible person - Persian: عاطفه کامرانی
Street address - English: Taleghani hospital, phase2 Padashahr
Street address - Persian: فاز دو پاداشهر، بیمارستان طالقانی
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 61339611151
Phone: +98 61 3554 0256
Fax:
Email: htaleghani@ajums.ac.ir
Web page address:
Name of recruitment center - English: Taleghani hospital Name of recruitment center - Persian: بیمارستان طالقانی Full name of responsible person - English: Atefeh Kamrani Full name of responsible person - Persian: عاطفه کامرانی Street address - English: Taleghani hospital, Padashahr phase2 , Ahvaz, KhouzestanPadashahr Street address - Persian: خوزستان ، اهواز ،فاز دو پادا شهر پاداشهر، بیمارستان طالقانی City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 61339611151 Phone: +98 61 3554 0256 Fax: Email: htaleghani@ajums.ac.ir Web page address:
#4
Name of recruitment center - English: Allameh Karami hospital
Name of recruitment center - Persian: بیمارستان علامه کرمی
Full name of responsible person - English: Atefeh Kamrani
Full name of responsible person - Persian: عاطفه کامرانی
Street address - English: Allameh Karami hospital, Baharanstreet, Ahvaz, Khouzestan
Street address - Persian: خوزستان ، اهواز ،خیابان بهاران ، بیمارستان علامه کرمی
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 61339 11151
Phone: +98 61 3377 7768
Fax:
Email: info@karamihospital.ir
Web page address:
Name of recruitment center - English: Allameh Karami hospital
Name of recruitment center - Persian: بیمارستان علامه کرمی
Full name of responsible person - English: Atefeh Kamrani
Full name of responsible person - Persian: عاطفه کامرانی
Street address - English: Allameh Karami hospital, Baharan street
Street address - Persian: خیابان بهاران ، بیمارستان علامه کرمی
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 61339 11151
Phone: +98 61 3377 7768
Fax:
Email: info@karamihospital.ir
Web page address:
Name of recruitment center - English: Allameh Karami hospital Name of recruitment center - Persian: بیمارستان علامه کرمی Full name of responsible person - English: Atefeh Kamrani Full name of responsible person - Persian: عاطفه کامرانی Street address - English: Allameh Karami hospital, Baharanstreet, Ahvaz, KhouzestanBaharan street Street address - Persian: خوزستان ، اهواز ،خیابان بهاران ، بیمارستان علامه کرمی City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 61339 11151 Phone: +98 61 3377 7768 Fax: Email: info@karamihospital.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: مهرنوش ذاکرزاده
Full name of responsible person - Persian: Mehrnoosh Zakerkish
Street address - English: School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Ahvaz University City, Khouzestan Ahvaz Ahvaz Khouzestan Iran, Islamic Republic Of
Street address - Persian: خوزستان، اهواز، شهر دانشگاهی، دانشگاه علوم پزشکی جندی شاپور اهواز، دانشکده پرستاری و مامایی، گروه مامایی خوزستان ایران اهواز خوزستان ایران
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 15794-61357
Phone: +98 61 3336 2414
Fax:
Email: itc@ajums.ac.ir
Web page address: http://vchresearch.ajums.ac.ir
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mehrnoosh Zakerzadeh
Full name of responsible person - Persian: مهرنوش ذاکرزاده
Street address - English: School of Nursing and Midwifery, Jundishapur University of Medical Sciences, University town
Street address - Persian: شهرک دانشگاهی، دانشگاه علوم پزشکی جندی شاپور، دانشکده پرستاری و مامایی
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 15794-61357
Phone: +98 61 3336 2414
Fax:
Email: itc@ajums.ac.ir
Web page address: http://vchresearch.ajums.ac.ir
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: مهرنوش ذاکرزادهMehrnoosh Zakerzadeh Full name of responsible person - Persian: Mehrnoosh Zakerkishمهرنوش ذاکرزاده Street address - English: School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Ahvaz University City, Khouzestan Ahvaz Ahvaz Khouzestan Iran, Islamic Republic Oftown Street address - Persian: خوزستان، اهواز، شهرشهرک دانشگاهی، دانشگاه علوم پزشکی جندی شاپور اهواز، دانشکده پرستاری و مامایی، گروه مامایی خوزستان ایران اهواز خوزستان ایران City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 15794-61357 Phone: +98 61 3336 2414 Fax: Email: itc@ajums.ac.ir Web page address: http://vchresearch.ajums.ac.ir
Protocol summary
Study aim
Implementing and evaluation labor and delivery management program using the world health organization safe childbirth checklist
Design
This study will be Stratified randomized controlled trial across eligible governmental hospitals in Ahvaz. four eligible hospitals will be identified. We will match hospitals (i.e. strata) according being educational or not so that We will have an educational hospital and a non- educational hospital in each strata.
Due to the fact that randomization will be performed on the basis of hospitals, not individually, the women admitted in each of these hospitals will be assigned to only one intervention group. Sampling of pregnant women will be done in convenience non -probability. All eligible women will select as a subject and this will be continued until we can gain the final sample size in each center.
Settings and conduct
Taleghani and Imam Khomeini are educational hospitals and Sina and Allameh Karami are not . In intervention groups pregnant women will be recieved evidence-based cares in accordance with the Safe Childbirth Checklist and control groups will be recieved routins care. Maternal and neonatal outcomes in each pregnant woman will be observed and recorded. Then ,they will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All providers who will be trained on evidence-based cares in accordance with the Safe Childbirth Checklist.
singleton pregnant women with gestational age 37 weeks or over who are admitted for vaginal delivery
Intervention groups
all care providers in intervention hospitals will be trained Necessary training on evidence-based cares based on World Health Organization Safe Childbirth Checklist.
Care providers in control hospitals will provide routine cares
Main outcome variables
Mother’s satisfaction of delivery , Mother’s experience of delivery and the type of delivery
General information
Reason for update
The type of sampling has been cluster randomized but it has the characteristics of stratified sampling and due to the low number of births in hospitals, it took six months instead of two months to reach the sample size.
Acronym
IRCT registration information
IRCT registration number:IRCT20220501054711N1
Registration date:2022-05-10, 1401/02/20
Registration timing:prospective
Last update:2023-03-11, 1401/12/20
Update count:1
Registration date
2022-05-10, 1401/02/20
Registrant information
Name
Atefeh Kamrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3328 1757
Email address
kamrani.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-05, 1401/03/15
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
2022-06-05, 1401/03/15
Actual recruitment end date
2022-12-06, 1401/09/15
Trial completion date
2023-01-20, 1401/10/30
Scientific title
Comparison of the Effectiveness of management of labor and delivery with using training on evidence-based cares based on the world health organization safe childbirth checklist and routine performance on maternal and neonatal outcomes
Public title
Implementing and evaluation labor and delivery management program using the world health organization safe childbirth checklist :An Embedded mixed-method study
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
All care providers who are responsible for caring for women who have been admitted for childbirth
Pregnant women who have inclusion critria
All Pregnant women who have singleton pregnancy and with gestational age 37 weeks or over with any ages, ethnicity, any history of obstetrics and any number of deliveries, who are admitted for vaginal delivery
Exclusion criteria:
Reluctance to participate in the trial
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
944
Actual sample size reached:
944
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be a Stratified randomized controlled trial across eligible governmental hospitals in Ahvaz. four eligible hospitals will be
identified. We will match hospitals (i.e.strata) according being educational or not, so that We will have an educational hospital and a non- educational hospital in each strata.
Due to the fact that randomization will be performed on the basis of hospitals, not individually, the women admitted in each of these hospitals will be assigned to only one intervention group. 236 eligible pregnant women will be enrolled in each of the hospitals and this will be continued until we can gain the final sample size in each center. Sampling of pregnant women will be done in convenience non -probability.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ethics committee of Ahvaz Jundishapur University of Medical Sciences, Farvardin street, Gorleston Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2022-04-16, 1401/01/27
Ethics committee reference number
IR.AJUMS.REC.1401.049
Health conditions studied
1
Description of health condition studied
Normal vaginal Delivery Management
ICD-10 code
O80
ICD-10 code description
Single spontaneous delivery
Primary outcomes
1
Description
Mother’s satisfaction of delivery
Timepoint
Before discharging of hospital
Method of measurement
Mackey Childbirth Satisfaction Rating Scale
2
Description
Mother’s experience of delivery
Timepoint
4-6 weeks after delivery
Method of measurement
childbirth experience questionnaire 2/0
3
Description
Type of delivery
Timepoint
After of delivery
Method of measurement
Observation and record in check list
Secondary outcomes
1
Description
Apgar score below 7
Timepoint
At 1 and 5 minutes after birth
Method of measurement
Observation and examination
2
Description
Frequency of newborn admission to neonatal ward or NICU
Timepoint
After of delivery
Method of measurement
Observation / record in check list
3
Description
Shoulder dystocia
Timepoint
During delivery
Method of measurement
Observation and record in check list
4
Description
Postpartum hemorrhage
Timepoint
after of delivery
Method of measurement
Increased maternal pulse rate above 110 beats per minute and maternal systolic blood pressure less than 90 mm Hg with vaginal bleeding. Hematocrit will be measured at baseline and then 8 hours after delivery.
5
Description
Maternal infections
Timepoint
During labor and delivery up to 42 days after delivery
Method of measurement
Sublingual temperature of 39 degrees or more or between 38-39 degrees that persists after 30 minutes Examination/ record in check list
6
Description
Frequency of third and fourth-degree perineal lacerations
Timepoint
After of delivery
Method of measurement
Observation and record in check list
7
Description
Near miss morbidity
Timepoint
From the time of hospitalization until 42 days after delivery
Method of measurement
Based on cardiovascular, pulmonary, renal, hepatic and uterine dysfunction
Intervention groups
1
Description
Intervention group: In intervention groups, the Labor and delivery program management will be based on evidence-based care in accordance with the World Health Organization safe childbirth checklist. In these hospitals, the researcher will give the necessary training of labor and delivery management program based on evidence-based care standards in according to the safe childbirth checklist to all care providers (midwives, residents, gynecologists) who work in labor and delivery ,the operating room and postpartum ward. These trainings will be done in groups of ten over several three-hour sessions, so that all care providers will be able to participate in these sessions. Training will be in the form of lectures, training booklets and practical simulations. After training in the intervention hospitals, volunteer care providers to participate in the trial, will manage labor and delivery according to the mentioned program . In order to reduce the probability of error in the study, the people evaluating the maternal and neonatal consequences will be different from the people in the research group. Four evaluators (midwives with 5 to 7 years of Work experience) will receive the necessary training by the researcher during two, two-hour training sessions on how to assess maternal and neonatal outcomes. To reduce the error of bias by the evaluators, they do not have any employment cooperation in the mentioned hospitals. Initially, according to the data quality assurance protocol, the researcher will evaluate the maternal and neonatal outcomes with the evaluators until each evaluator achieves 100% accuracy and compliance with the standard in the evaluation of maternal and neonatal outcomes. Then they will follow up maternal and neonatal outcomes independently in intervention and control hospitals. Neonatal outcomes up to 7 days and maternal outcomes up to 42 days after delivery will be followed up and compared in both groups.
Category
N/A
2
Description
Control group: current position
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital karoon
Full name of responsible person
Atefeh Kamrani
Street address
Sina hospital, 5th Gandomkar Ave, Imam Ali Square, Kut Abdullah
City
Ahvaz
Province
Khouzestan
Postal code
17111 61991
Phone
+98 61 3555 0592
Email
sinahospital.ch@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Imam khomeiney hospital
Full name of responsible person
Atefeh Kamrani
Street address
Imam khomeiney hospital, Azadegan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۹۳۶۷۳۱۶۶
Phone
+98 61 1222 2922
Email
himam@ajums.ac.ir
Web page address
http://bankpezeshkan.co
3
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Atefeh Kamrani
Street address
Taleghani hospital, phase2 Padashahr
City
Ahvaz
Province
Khouzestan
Postal code
61339611151
Phone
+98 61 3554 0256
Email
htaleghani@ajums.ac.ir
4
Recruitment center
Name of recruitment center
Allameh Karami hospital
Full name of responsible person
Atefeh Kamrani
Street address
Allameh Karami hospital, Baharan street
City
Ahvaz
Province
Khouzestan
Postal code
61339 11151
Phone
+98 61 3377 7768
Email
info@karamihospital.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerzadeh
Street address
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, University town
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Web page address
http://vchresearch.ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Atefeh Kamrani
Position
Phd of midwifery student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Jundishapur medical university, Farvardin street, Gorleston Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 2414
Email
atykamrani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mina Iravani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Farvardin street, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8538
Email
minairavani2004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Atefeh Kamrani
Position
Ph.D of Midwifery student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Farvardin street, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 2414
Email
atykamrani@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data of this study will be accessible upon the request form the corresponding author after publication, or we may deposit our data in the “Figshare” for sharing with other researchers after the publication of the manuscript.
When the data will become available and for how long
The data will be accessible upon the request from the corresponding author or in the Figshare” after publication of the manuscript (we anticipate this time by the end of 2023).
To whom data/document is available
Our data will be accessible upon the request from faculty members who interested to use our data with the research purpose (with acknowledgement of authors in our study)
Under which criteria data/document could be used
Interested researchers can send an e-mail to the corresponding author and request our data. In case of if we deposited our data in the “Figshare” cite, they will be accessible from the cite
From where data/document is obtainable
Mina Iravani-Iran, Ahvaz, Golestan Ave, Ahvaz Jundishapur University of Medical Sciences, Nursing & Midwifery School, Midwifery Department
What processes are involved for a request to access data/document
The requested information will be sent at the most up to one week after receiving the email