Kharader General Hospital
Karachi, Sindh, Pakistan
NCT Number: NCT07615946
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.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Karachi, Sindh, Pakistan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: membrane stripping, Cervical Sweeping, Sweeping of membrane
participants in the control group will receive routine obstetric care and routine vaginal examination without membrane sweeping
Time frame: 38 to 41 weeks of gestation
number of participants who achieve spontaneous labour without formal induction
Time frame: at 41 weeks of gestation
number of participants requiring pharmacological or surgical induction of labour
Time frame: During labour and with in 24 hours after delivery
Assessment of PPH. PROM, meconium stained amniotic fluid and maternal infection
Kharadar General Hospital
Other
Acronym: EMSTDOLTCH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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