Comparison of Routine Versus Restrictive Episiotomy in Primigravida Women at Term.

NCT07796685 | Completed

• 1 other identifier: Dr-Ammara-Multan
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 1

Brief Summary

The ongoing debate over routine versus selective episiotomy in primiparous term women underscores the necessity for updated local data. Consequently, this study was designed to compare the outcomes-specifically regarding perineal tears and postpartum hemorrhage (PPH)-between routine and selective episiotomy in primigravida women at term.

Conditions

Labor Complication

Outcome Measures

Primary Outcomes (2)

• Perineal tear

  Frequency of patients with perineal tear, defined as presence of laceration or disruption at any level from skin to the muscles and anal sphincters, was noted, .

  Immediately after the procedure

• Postpartum Hemorrhage

  Frequency of patients with postpartum hemorrhage, defined as Blood loss of more than 500 mL after vaginal delivery measured as one full kidney tray, was noted.

  Immediately after the procedure

Study Arms (2)

Routine Episiotomy

EXPERIMENTAL

Patients were managed by routine method in which episiotomy was performed without any indication.

Procedure: Routine Episiotomy

Restrictive Episiotomy

EXPERIMENTAL

The patient underwent restrictive episiotomy when clinically indicated due to a risk of a third- or fourth-degree perineal tear or fetal compromise.

Procedure: Restrictive Episiotomy

Interventions

Routine Episiotomy PROCEDURE

Patients were managed by routine method in which episiotomy was performed without any indication.

Routine Episiotomy

Restrictive Episiotomy PROCEDURE

The patient underwent restrictive episiotomy when clinically indicated due to a risk of a third- or fourth-degree perineal tear or fetal compromise.

Restrictive Episiotomy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primigravida
• Aged18 - 40 years
• Gestational age of ≥ 37 weeks
• Admitted to the labor room (either spontaneous or induced labor) for episiotomy

You may not qualify if:

• Abnormal and cephalic presentations with occipitoposterior position
• Instrumental delivery (vacuum or forceps)
• Pre - eclampsia / Eclampsia
• Gestational diabetes mellitus
• Fetal abnormality
• Intrauterine growth restriction
• History of pelvic surgery or neuromuscular diseases
• Twin pregnancies
• Fetal macrosomia

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Nishtar Hospital/Medical University

Multan, Punjab Province, 66000, Pakistan

Location

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ammara Khaliq

  Nishtar Hospital/Medical University, Multan, Pakistan.

  PRINCIPAL INVESTIGATOR

• Syeda Ali, FCPS

  Nishtar Hospital/Medical University, Multan, Pakistan.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: May 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)