ClinicalTrials.gg
CompletedNCT07796685Updated Sep 1, 2026

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

An interventional study of Routine Episiotomy and Restrictive Episiotomy in Labor Complication, sponsored by Muhammad Aamir Latif. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Muhammad Aamir Latif · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled May 2025, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
466
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Labor Complication
03

In context

Obstetric Labor Complications

88 studies on the registry are indexed under Obstetric Labor Complications; 24 are open to participants now.

This study's enrollment of 466 is above the median of 159 across 63 interventional studies indexed under Obstetric Labor Complications.

Browse Obstetric Labor Complications studies →

Lead sponsor

Muhammad Aamir Latif is the lead sponsor of 58 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
466 participants (actual)

Study arms

  • Experimental
    Routine Episiotomy

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

    Procedure: Routine Episiotomy

  • Experimental
    Restrictive Episiotomy

    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

  • 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.

06

What researchers measure

Primary outcomes

  1. 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, .

    Time frame: Immediately after the procedure

  2. 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.

    Time frame: Immediately after the procedure

07

Study locations

1 site
  • Nishtar Hospital/Medical University
    Multan, Punjab Province 66000, Pakistan
08

References and documents

Individual participant data

Plan to share: No — Data can be shared on a reasonable request.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2025 to primary completion in Oct 2025, 5 months.

Of 27 interventional studies with no phase under Obstetric Labor Complications, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 51. This study's 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2026
First posted
Sep 1, 2026
StartActual
May 1, 2025
Primary completionActual
Oct 31, 2025
CompletionActual
Oct 31, 2025
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07796685
Lead sponsor
Muhammad Aamir Latif
Responsible party
Muhammad Aamir Latif (Research Consultant, RESnTEC, Institute of Research) — Sponsor-investigator
First posted
Sep 1, 2026
Start date
May 1, 2025
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025
Last update
Sep 1, 2026

Study contacts

Ammara Khaliq
principal investigator · Nishtar Hospital/Medical University, Multan, Pakistan.
Syeda Ali, FCPS
study director · Nishtar Hospital/Medical University, Multan, Pakistan.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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