Effect of Membrane Sweeping at Term on Duration of Onset of Labour at Tertiary Care Hospital (EMSTDOLTCH) (EMSTDOLTCH)
The goal of this clinical trial is to learn whether membrane sweeping can help start labour naturally and improve delivery outcomes in women with term pregnancy. Membrane sweeping is a simple procedure performed during a vaginal examination in which a healthcare provider gently separates the membranes around the baby from the lower part of the uterus. This may help the body release natural hormones that encourage labour to begin.
This study will include pregnant women aged 18 to 45 years with uncomplicated singleton pregnancies between 38 and 41 weeks of gestation. The main questions this study aims to answer are:
- Does membrane sweeping reduce the time taken for labour to start naturally?
- Does membrane sweeping reduce the need for medical induction of labour and cesarean section?
- Does membrane sweeping improve maternal and newborn outcomes at term pregnancy?
Researchers will compare women who undergo membrane sweeping with women who receive routine care without membrane sweeping to determine whether the procedure improves labour and delivery outcomes.
Participants in the membrane sweeping group will undergo membrane sweeping during routine vaginal examination from 38 weeks of pregnancy until labour starts or until 41 weeks of gestation. Participants in the control group will receive routine antenatal and obstetric care without membrane sweeping. Researchers will record the onset of labour, duration of labour, mode of delivery, and maternal and newborn complications during and after delivery.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Labour induction is one of the most common interventions performed in obstetric practice, particularly in women with prolonged or post-term pregnancy. Delayed onset of labour at term pregnancy may increase the risk of maternal and neonatal complications, including cesarean section, fetal distress, meconium-stained amniotic fluid, and neonatal intensive care unit (NICU) admission. Membrane sweeping is a simple mechanical technique that may help stimulate the natural onset of labour by promoting the release of endogenous prostaglandins and enhancing cervical ripening.
This randomized controlled trial will be conducted at the Department of Obstetrics and Gynaecology, Kharadar General Hospital, Karachi. The study will aim to evaluate the effectiveness and safety of membrane sweeping in women with uncomplicated term pregnancy between 38 and 41 weeks of gestation.
A total of 214 pregnant women aged 18 to 45 years with singleton pregnancies and cephalic presentation will be enrolled in the study. Participants will be allocated into two groups. Women in the intervention group will undergo membrane sweeping during routine vaginal examination, while women in the control group will receive routine obstetric care without membrane sweeping.
Membrane sweeping will be performed by the attending obstetrician by inserting one or two gloved fingers through the cervix and gently separating the fetal membranes from the lower uterine segment using a circular sweeping motion. The procedure may be repeated weekly from 38 weeks of gestation until spontaneous labour occurs or until 41 weeks of gestation. Women who do not enter spontaneous labour by 41 weeks may undergo formal induction of labour according to hospital protocol.
The study will assess the duration between intervention and onset of labour, spontaneous onset of labour, need for induction of labour, and mode of delivery. Maternal outcomes including postpartum hemorrhage, premature rupture of membranes, meconium-stained amniotic fluid, and maternal infection will also be evaluated. Neonatal outcomes including low Apgar score, fetal distress, neonatal infection, low birth weight, NICU admission, and neonatal mortality will be recorded.
Data collected during the study will be analyzed to determine whether membrane sweeping is associated with earlier onset of labour, reduced need for induction, lower cesarean section rates, and improved maternal and neonatal outcomes. The findings of this study may help provide evidence regarding the role of membrane sweeping as a safe, low-cost, and effective intervention for management of term pregnancies.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
Sindh
-
Karachi、Sindh、パキスタン
- Kharader General Hospital
-
-
参加基準
適格基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Singleton pregnancy.
- Cephalic presentation.
- Gestational age between 38 and 41 weeks.
- Intact fetal membranes.
- Women with uncomplicated term pregnancy.
Exclusion Criteria:
- Women unwilling to participate in the study.
- Multiple pregnancies.
- Mal-presentation.
- Placenta previa or placental abruption.
- Previous uterine surgery or previous two cesarean sections.
- Premature rupture of membranes.
- Gestational hypertension or diabetes mellitus.
- Severe fetal anomalies.
- Active cervical or genital herpes infection.
- Contraindications to vaginal delivery.
- High-risk pregnancy requiring immediate intervention.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Membrane sweeping group
participants in this group will undergo membrane sweeping during routine vaginal examination from 38 weeks of gestation until spontaneous labour occur or until 41 weeks of gestation
|
membrane sweeping will be performed by inserting one or two gloved fingers through the cervix and gently separating the fetal membranes from the lower uterine segment using a circular sweeping motion during vaginal examination
他の名前：
|
|
アクティブコンパレータ：No intervention / Active comparator
participants in this group will receive routine obstetric care and routine vaginal examination without membrane sweeping
|
participants in the control group will receive routine obstetric care and routine vaginal examination without membrane sweeping
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
spontaneous Onset of Labour
時間枠：38 to 41 weeks of gestation
|
number of participants who achieve spontaneous labour without formal induction
|
38 to 41 weeks of gestation
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Induction of labour
時間枠：at 41 weeks of gestation
|
number of participants requiring pharmacological or surgical induction of labour
|
at 41 weeks of gestation
|
|
maternal Complication
時間枠：During labour and with in 24 hours after delivery
|
Assessment of PPH.
PROM, meconium stained amniotic fluid and maternal infection
|
During labour and with in 24 hours after delivery
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Finucane EM, Murphy DJ, Biesty LM, Gyte GM, Cotter AM, Ryan EM, Boulvain M, Devane D. Membrane sweeping for induction of labour. Cochrane Database Syst Rev. 2020 Feb 27;2(2):CD000451. doi: 10.1002/14651858.CD000451.pub3.
- 11. Batham SK, Kori A, Sirpurkar MS. Sweeping of the fetal membranes and its effect on duration of pregnancy in low risk cases. Int J Reprod Contracept Obstet Gynecol 2020;9:2118-21.
- 10. National Institute for Health and Care Excellence. Inducing labour. Clinical guideline [CG70]. Available from: https://www.nice.org.uk/guidance/cg70/chapter/4-researchrecommendations (accessed 4th February 2024]. 2008.
- 9. Blackburn S. Maternal, Fetal, & Neonatal Physiology - A Clinical Perspective. 3rd Edition. Missouri: Saunders Elsevier, 2013.
- Boulvain M, Kelly A, Irion O. Intracervical prostaglandins for induction of labour. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD006971. doi: 10.1002/14651858.CD006971.
- Tan PC, Khine PP, Sabdin NH, Vallikkannu N, Sulaiman S. Effect of membrane sweeping on cervical length by transvaginal ultrasonography and impact of cervical shortening on cesarean delivery. J Ultrasound Med. 2011 Feb;30(2):227-33. doi: 10.7863/jum.2011.30.2.227.
- Zamzami TY, Al Senani NS. The Efficacy of Membrane Sweeping at Term and Effect on the Duration of Pregnancy: A Randomized Controlled Trial. Clin Gynecol Obstet. 2014;3(1):30-34.
- World Health Organization. WHO recommendations for induction of labour. Available from: http://apps.who.int/iris/bitstream/ 10665/44531/1/ 9789241501156_eng.pdf (accessed 4th February 2024).
- Bakker JJH, van der Goes BY, Pel M, Mol BW, van der Post JA. Morning versus evening induction of labour for improving outcomes. Cochrane Database of Systematic Reviews 2013, Issue 2. [DOI: 10.1002/14651858.CD007707]
- Pirzada H, Shabir R, Ehsan A, Tahir N, Saifuddin Z, Fatima A. Sweeping of membranes for induction of labour in low-risk term pregnancy. Pakistan Armed Forces Medical Journal. 2022;72(2):658-661
- Ali A, Iqbal S, Rashid T. The effectiveness of membrane sweeping at term and clinical effects on duration of pregnancy. Annals of KEMU. 2021;27(2):223-227.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- KGH-ERB:2025/012
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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