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Term PregnancyEMSTDOLTCHNCT07615946

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

A study testing membrane sweeping and Routine Vaginal examination in people with Term Pregnancy and Labour Induction, run by Kharadar General Hospital at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
membrane sweeping and Routine Vaginal examination
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
1 sitePakistan
Study dates
1 Jan 2025to 31 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 11Show fewer
  • Gestational hypertension or diabetes mellitus.
  • Severe fetal anomalies.
  • Active cervical or genital herpes infection.
  • Contraindications to vaginal delivery.
  • High-risk pregnancy requiring immediate intervention.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Kharader General Hospital

    Karachi, Sindh

Other trials in Pakistan

About this study

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:

Read more
  • 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.

Read the 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.

Being tested
membrane sweeping, Routine Vaginal examination
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
Medical subject headings
Pregnancy, Prolonged

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • membrane sweepingProcedure or surgery

    Also called membrane stripping, Cervical Sweeping, Sweeping of membrane

    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

  • Routine Vaginal examinationProcedure or surgery

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

Study groups in NCT07615946
Study groupRoleWhat they receive
Membrane sweeping groupExperimentalparticipants 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
Receives: Procedure: membrane sweeping
No intervention / Active comparatorActive comparatorparticipants in this group will receive routine obstetric care and routine vaginal examination without membrane sweeping
Receives: Procedure: Routine Vaginal examination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. spontaneous Onset of Labour

    number of participants who achieve spontaneous labour without formal induction

    Measured: 38 to 41 weeks of gestation

Secondary outcomes (2)
  1. Induction of labour

    number of participants requiring pharmacological or surgical induction of labour

    Measured: at 41 weeks of gestation

  2. maternal Complication

    Assessment of PPH. PROM, meconium stained amniotic fluid and maternal infection

    Measured: During labour and with in 24 hours after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study start1 Jan 2025
  3. Primary completion31 Jan 2026
  4. Study completion31 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07615946
Sponsor's protocol ID
KGH-ERB:2025/012
Acronym
EMSTDOLTCH
Status last verified
May 2026
First submitted
13 May 2026
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: individual participant data collected during this study ill not be publicly available

Publications

  • 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;2008(1):CD006971. doi: 10.1002/14651858.CD006971.

    PubMed 18254122
  • 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.

    PubMed 21266561
  • 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]

  • 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.

    PubMed 32103497
  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing membrane sweeping and Routine Vaginal examination in people with Term Pregnancy and Labour Induction, run by Kharadar General Hospital at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

spontaneous Onset of Labour (time frame: 38 to 41 weeks of gestation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07615946, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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