Labor ComplicationNCT07796685
Comparison of Routine Versus Restrictive Episiotomy in Primigravida Women at Term.
A study testing Routine Episiotomy and Restrictive Episiotomy in people with Labor Complication, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor Complication
- What is being tested?
- Routine Episiotomy and Restrictive Episiotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primigravida
- Aged18 - 40 years
- Gestational age of ≥ 37 weeks
- Admitted to the labor room (either spontaneous or induced labor) for episiotomy
Who cannot join
- Abnormal and cephalic presentations with occipitoposterior position
- Instrumental delivery (vacuum or forceps)
- Pre - eclampsia / Eclampsia
- Gestational diabetes mellitus
- Fetal abnormality
- Intrauterine growth restriction
Show all 9Show fewer
- History of pelvic surgery or neuromuscular diseases
- Twin pregnancies
- Fetal macrosomia
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Nishtar Hospital/Medical University
Multan, Punjab Province, 66000
About this study
Official title: Comparison of Outcome in Terms of Perineal Tear and Postpartum Hemorrhage (PPH) in 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.
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.
- Conditions
- Labor Complication
- Being tested
- Routine Episiotomy, Restrictive Episiotomy
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine EpisiotomyProcedure or surgery
Patients were managed by routine method in which episiotomy was performed without any indication.
Restrictive EpisiotomyProcedure or surgery
The patient underwent restrictive episiotomy when clinically indicated due to a risk of a third- or fourth-degree perineal tear or fetal compromise.
| Study group | Role | What they receive |
|---|---|---|
| Routine Episiotomy | Experimental | Patients were managed by routine method in which episiotomy was performed without any indication. Receives: 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. Receives: Procedure: Restrictive Episiotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, .
Measured: 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.
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 May 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Ammara Khaliq, Principal investigator, Nishtar Hospital/Medical University, Multan, Pakistan.Syeda Ali, FCPS, Study director, Nishtar Hospital/Medical University, Multan, Pakistan.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796685
- Sponsor's protocol ID
- Dr-Ammara-Multan
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcome in Terms of Perineal Tear and Postpartum Hemorrhage (PPH) in Routine Versus Restrictive Episiotomy in Primigravida Women at Term.
- ClinicalTrials.gov ID
- NCT07796685
- Acronym / sponsor ID
- Dr-Ammara-Multan
- Conditions
- Labor Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Episiotomy | Experimental | Procedure: Routine EpisiotomyPatients were managed by routine method in which episiotomy was performed without any indication. |
| Restrictive Episiotomy | Experimental | Procedure: Restrictive EpisiotomyThe patient underwent restrictive episiotomy when clinically indicated due to a risk of a third- or fourth-degree perineal tear or fetal compromise. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primigravida
- Aged18 - 40 years
- Gestational age of ≥ 37 weeks
- Admitted to the labor room (either spontaneous or induced labor) for episiotomy
Key exclusion criteria (9 listed)
- Abnormal and cephalic presentations with occipitoposterior position
- Instrumental delivery (vacuum or forceps)
- Pre - eclampsia / Eclampsia
- Gestational diabetes mellitus
- Fetal abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine EpisiotomyPatients were managed by routine method in which episiotomy was performed without any indication. | Procedure or surgery | Routine Episiotomy |
| Restrictive EpisiotomyThe patient underwent restrictive episiotomy when clinically indicated due to a risk of a third- or fourth-degree perineal tear or fetal compromise. | Procedure or surgery | Restrictive Episiotomy |
Primary outcome
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, .
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ammara Khaliq principal investigator
Nishtar Hospital/Medical University, Multan, Pakistan.
Syeda Ali, FCPS study director
Nishtar Hospital/Medical University, Multan, Pakistan.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Episiotomy and Restrictive Episiotomy in people with Labor Complication, run by Muhammad Aamir Latif at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perineal tear (time frame: Immediately after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.