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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07796685

Enrollment

466

Registered

2026-09-01

Start date

2025-05-01

Completion date

2025-10-31

Last updated

2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Complication

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.

Detailed description

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.

Interventions

PROCEDURERoutine Episiotomy

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

PROCEDURERestrictive Episiotomy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Perineal tear	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, .
Postpartum Hemorrhage	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.

Countries

Pakistan

Contacts

PRINCIPAL_INVESTIGATORAmmara Khaliq

Nishtar Hospital/Medical University, Multan, Pakistan.

STUDY_DIRECTORSyeda Ali, FCPS