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

25. maj 2026 opdateret af: Kharadar General Hospital

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

214

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Sindh
      • Karachi, Sindh, Pakistan
        • Kharader General Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Andre navne:
  • membrane stripping
  • Cervical Sweeping
  • Sweeping of membrane
Aktiv komparator: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
spontaneous Onset of Labour
Tidsramme: 38 to 41 weeks of gestation
number of participants who achieve spontaneous labour without formal induction
38 to 41 weeks of gestation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Induction of labour
Tidsramme: at 41 weeks of gestation
number of participants requiring pharmacological or surgical induction of labour
at 41 weeks of gestation
maternal Complication
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2025

Primær færdiggørelse (Faktiske)

31. januar 2026

Studieafslutning (Faktiske)

31. januar 2026

Datoer for studieregistrering

Først indsendt

13. maj 2026

Først indsendt, der opfyldte QC-kriterier

25. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Arbejdsinduktion

Kliniske forsøg med membrane sweeping

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