NCT07615946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

May 13, 2026

Last Update Submit

May 25, 2026

Conditions

Keywords

membrane sweepingterm pregnancylabour inductionspontaneous labourvaginal deliverycesarean sectionmaternal outcomeneonatal outcomecervical ripeningobstetricspregnancy at termmechanical induction of labour

Outcome Measures

Primary Outcomes (1)

  • spontaneous Onset of Labour

    number of participants who achieve spontaneous labour without formal induction

    38 to 41 weeks of gestation

Secondary Outcomes (2)

  • Induction of labour

    at 41 weeks of gestation

  • maternal Complication

    During labour and with in 24 hours after delivery

Study Arms (2)

Membrane sweeping group

EXPERIMENTAL

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

Procedure: membrane sweeping

No intervention / Active comparator

ACTIVE COMPARATOR

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

Procedure: Routine Vaginal examination

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

Also known as: membrane stripping, Cervical Sweeping, Sweeping of membrane
Membrane sweeping group

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

No intervention / Active comparator

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton pregnancy.
  • Cephalic presentation.
  • Gestational age between 38 and 41 weeks.
  • Intact fetal membranes.
  • Women with uncomplicated term pregnancy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kharader General Hospital

Karachi, Sindh, Pakistan

Location

Related Publications (11)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 9. Blackburn S. Maternal, Fetal, & Neonatal Physiology - A Clinical Perspective. 3rd Edition. Missouri: Saunders Elsevier, 2013.

    BACKGROUND
  • 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.

    PMID: 18254122BACKGROUND
  • 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.

    PMID: 21266561BACKGROUND
  • 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.

    BACKGROUND
  • 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).

    BACKGROUND
  • 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]

    BACKGROUND
  • 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.

    PMID: 32103497BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Pregnancy, Prolonged

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 29, 2026

Study Start

January 1, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

individual participant data collected during this study ill not be publicly available

Locations