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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Sindh
-
Karachi, Sindh, Pakistan
- Kharader General Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
|
|
Comparateur actif: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
spontaneous Onset of Labour
Délai: 38 to 41 weeks of gestation
|
number of participants who achieve spontaneous labour without formal induction
|
38 to 41 weeks of gestation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Induction of labour
Délai: at 41 weeks of gestation
|
number of participants requiring pharmacological or surgical induction of labour
|
at 41 weeks of gestation
|
|
maternal Complication
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KGH-ERB:2025/012
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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