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Completed

NCT Number: NCT07796685

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

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.

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Key information

Conditions

Labor Complication Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nishtar Hospital/Medical University

Multan, Punjab Province, 66000, Pakistan

About this study

Perineal tears remain a common concern following normal vaginal delivery, particularly among primigravida women delivering at term. Episiotomy has traditionally been performed to reduce the risk or severity of perineal trauma, although the benefits of routine versus selective episiotomy remain a subject of ongoing debate. While routine episiotomy may be considered protective in some circumstances, restrictive use has also been advocated to avoid unnecessary perineal injury and other associated complications. This study aims to provide baseline data on perineal tears among primigravida women undergoing normal vaginal delivery, thereby promoting greater vigilance during labor and delivery. The findings may also help obstetricians make informed decisions regarding the appropriate use and justification of episiotomy in this population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Routine Episiotomy

Procedure

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

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.

Primary outcomes

  1. Perineal tear

    Time frame: Immediately after the procedure

    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, .

  2. Postpartum Hemorrhage

    Time frame: Immediately after the procedure

    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.

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

Comparison of Outcome in Terms of Perineal Tear and Postpartum Hemorrhage (PPH) in Routine Versus Restrictive Episiotomy in Primigravida Women at Term.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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