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Effect Of Amniotomy In Early Labour On Duration Of Labour

NCT07764406 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-13

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if intentional rupturing of amniotic sac in early labour works to shorten the duration of labour.

The main question it aims to answer is

. Does the intentional rupture of amniotic sac in early labour lowers the duration of labour in primigravida at term as compared to expectant management.

The researchers will compare mean duration of labor in intentional rupture of amniotic sac in early labour group to expectant management untill spontaneous rupture of amniotic sac in primigravida at term pregnancy.

The participants will be randomly assigned to group A and B through lottery method using sealed opaque envelopes.

In group A, amniotomy at 3cm will be done using aseptic measurements with the help of forcep. while in group B, membranes will be left intact. A partograph will be maintained in all patients throughout labor. Duration of each stage of labour will be monitored as per operational definition by the nurse not aware of treatment given. Fetal and maternal monitoring will be done half hourly till delivery of infant. Cesarean-section will be done in non-reactive CTG patients. In case of any of the adverse events related to intervention like placental abruption and cord prolapse \[that is less likely as the subjects are primigravida patients in which head is mostly already engaged before onset of labour\], and presence of meconium upon ARM that is not related to intervention individualized care will be provided like continuous electronic fetal monitoring and emergency caserean section will be kept in hand. If any adverse event occur related to intervention it will be reported to IRB within 24hours. All the patients will be kept under observation for 24 hours after delivery. All the data will be recorded on proforma

Conditions

  • Labour

Interventions

PROCEDURE

Amniotomy (intentional rupture of amniotic sac during labour)

intentional rupture of amniotic sac during labour)

Sponsors & Collaborators

  • Indus Hospital and Health Network

    lead OTHER

Principal Investigators

  • Bushra Iqbal, MBBS · Indus Hospital and Health Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-03-30
Completion
2026-04-28

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07764406 on ClinicalTrials.gov