Effect Of Amniotomy In Early Labour On Duration Of Labour

NCT07764406 | Completed

• 1 other identifier: IHHN_IRB_2025_05_019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Amniotomy in early labour; Effect of amniotimy in early labour in primigravida at term

Outcome Measures

Primary Outcomes (1)

• Mean duration of labour in amniotomy group and spontaneous rupture of membranes in primigravida at term pregnancy

  To compare the mean duration of labour in primigravida at term pregnancy undergoing amniotomy in early labour at 3-4 cm cervical dilatation versus expectant management until spontaneous rupture of membranes.

  6 months

Study Arms (2)

Group A-Amniotimy group

ACTIVE COMPARATOR

amniotomy performed at 3 cm cervical dilatation using aseptic technique

Procedure: Amniotomy (intentional rupture of amniotic sac during labour)

Group B-Expectant group

NO INTERVENTION

Membranes left intact untill spontaneous rupture of membranes occur

Interventions

Amniotomy (intentional rupture of amniotic sac during labour) PROCEDURE

intentional rupture of amniotic sac during labour)

Group A-Amniotimy group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 - 45 years
• Primigravida, singleton fetus (on antenatal scan)
• Full term - gestational age 37 - 41 weeks
• Established labour (presence of regular uterine contractions - 3 per 10 minutes)

You may not qualify if:

• History of chronic hypertension, diabetes mellitus, gestational diabetes - on medical record
• Rupture of the membrane (pooling of fluid in vaginal on speculum examination)
• History of antepartum hemorrhage (history and medical record)

Sponsors & Collaborators

• Indus Hospital and Health Network: lead

Study Sites (1)

Indus hospital and health network

Multan, Punjab Province, 34200, Pakistan

Location

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MeSH Terms

Interventions

Amniotomy

Intervention Hierarchy (Ancestors)

Labor, Induced; Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Bushra Iqbal, MBBS

  Indus Hospital and Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post graduate resident FCPS Gynae & Obs RTEH Muzaffagarh

Model Details: Study design: Randomized Controlled Trial Duration: 6-months after approval of synopsis Sample size: Sample size is calculated through OpenEpi software using formula for mean difference. Where, Labour duration in amniotomy group = 5.725±0.59 hours Power of the study = 80% Labour duration in spontaneous membrane rupture = 7.150±0.48 hours Confidence level = 95% Sample size = 60 (30 in each group) Sampling technique: Non-probability consecutive sampling The participants randomly assigned to group A and B through lottery method using sealed opaque envelopes

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: August 13, 2026
• Study Start: October 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 28, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-07

Locations

PA (1)