NCT07537842

Brief Summary

The goal of this clinical trial is to find out which method of protecting the perineum during childbirth works better in reducing tears in first-time mothers. The study will compare two commonly used techniques-Finnish and Viennese manual perineal protection-during the second stage of labor. It will also assess whether these techniques are safe and practical to use. The main questions it aims to answer are:

  • Be enrolled when they are in active labor and planning a normal vaginal delivery
  • Be randomly assigned to one of the two perineal protection techniques
  • Have their labor monitored, including the duration of different stages of labor
  • Undergo a clinical examination after delivery to check for any perineal tears A trained obstetrician who is not aware of which technique was used will examine the mother after delivery to ensure unbiased assessment. Any tears identified will be treated according to standard hospital guidelines. By comparing these two techniques, this study aims to identify the safer and more effective method to reduce perineal injury during childbirth, which may help improve maternal outcomes and quality of care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 12, 2026

Last Update Submit

April 12, 2026

Conditions

Keywords

1st stage of labor2nd stage of laborPerineal tearViennese manual perineal protection (VMPP)Finnish manual perineal protection (FMPP)

Outcome Measures

Primary Outcomes (1)

  • Perineal Tear

    Perineal tear will be assessed by clinical examination after delivery. It is defined as any laceration involving the perineal skin, vaginal mucosa, perineal muscles, anal sphincter, or rectal mucosa. The presence or absence of a tear will be recorded.

    Immediately after delivery (within the third stage of labor)

Other Outcomes (2)

  • Duration of First Stage of Labor

    During labor (from onset of active labor to full cervical dilation)

  • Duration of Second Stage of Labor

    During labor (from full dilation to delivery)

Study Arms (2)

Finnish Manual Perineal Protection

EXPERIMENTAL

Participants in this group will receive manual perineal protection using the Finnish technique during the second stage of labor.

Procedure: Finnish Manual Perineal Protection Technique

Viennese Manual Perineal Protection

ACTIVE COMPARATOR

Participants in this group will receive manual perineal protection using the Viennese technique during the second stage of labor.

Procedure: Viennese Manual Perineal Protection

Interventions

This involves applying pressure with the flexed middle, ring, and little fingers to support the perineum and control delivery of the fetal head. This would reduce perineal stretching and tearing during delivery.

Finnish Manual Perineal Protection

This technique includes applying ventral pressure with the ulnar part of the palm while supporting the perineum and controlling fetal head extension at crowning.

Viennese Manual Perineal Protection

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Full-term (37 - 42 weeks, assessed through LMP)
  • Singleton pregnancy (assessed on antenatal scan)
  • Primigravida
  • In active labor

You may not qualify if:

  • Fetal presentation other than cephalic (confirmed on USG)
  • Patients converted to cesarean delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nishtar Medical University

Multan, Punjab Province, 60000, Pakistan

Location

Study Officials

  • Syeda A Professor, FCPS

    Nishtar Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 12, 2026

First Posted

April 17, 2026

Study Start

August 28, 2025

Primary Completion

March 2, 2026

Study Completion

March 2, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations