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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Sindh
-
Karachi, Sindh, Pakistán
- Kharader General Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Experimental: 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
Otros nombres:
|
|
Comparador activo: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
spontaneous Onset of Labour
Periodo de tiempo: 38 to 41 weeks of gestation
|
number of participants who achieve spontaneous labour without formal induction
|
38 to 41 weeks of gestation
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Induction of labour
Periodo de tiempo: at 41 weeks of gestation
|
number of participants requiring pharmacological or surgical induction of labour
|
at 41 weeks of gestation
|
|
maternal Complication
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- KGH-ERB:2025/012
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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