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Effect of Membrane Sweeping at Term on Duration of Onset of Labour at Tertiary Care Hospital (EMSTDOLTCH)

Effect of Membrane Sweeping at Term on Duration of Onset of Labour at Tertiary Care Hospital (EMSTDOLTCH)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07615946
Acronym
EMSTDOLTCH
Enrollment
214
Registered
2026-05-29
Start date
2025-01-01
Completion date
2026-01-31
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed Onset of Labour, Labour Induction, Post Term Pregnancy, Term Pregnancy

Keywords

membrane sweeping, term pregnancy, labour induction, spontaneous labour, vaginal delivery, cesarean section, maternal outcome, neonatal outcome, cervical ripening, obstetrics, pregnancy at term, mechanical induction of labour

Brief summary

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.

Detailed description

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.

Interventions

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

PROCEDURERoutine Vaginal examination

participants in the control group will receive routine obstetric care and routine vaginal examination without membrane sweeping

Sponsors

Kharadar General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants will be assigned into two parallel groups. One group will undergo membrane sweeping during routine vaginal examination, while the control group will receive routine obstetric care without membrane sweeping. Maternal and neonatal outcomes, onset and duration of labour, and mode of delivery will be compared between the two groups.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
spontaneous Onset of Labour38 to 41 weeks of gestationnumber of participants who achieve spontaneous labour without formal induction

Secondary

MeasureTime frameDescription
Induction of labourat 41 weeks of gestationnumber of participants requiring pharmacological or surgical induction of labour
maternal ComplicationDuring labour and with in 24 hours after deliveryAssessment of PPH. PROM, meconium stained amniotic fluid and maternal infection

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026