Pelvic Floor Training Program and Perineal Trauma During Vaginal Birth

NCT07292948 | Completed

• 1 other identifier: HU-PFTP-PERINEAL-TRAUMA-2025
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine whether a structured pelvic floor muscle training program during pregnancy can reduce perineal trauma during vaginal birth. Nulliparous pregnant women at 28 weeks of gestation or later were invited to participate. Women who chose to join the training program performed supervised pelvic floor exercises twice weekly and daily home exercises. Women who declined the program received standard antenatal care. The study compared rates of severe perineal tears (third- or fourth-degree lacerations), episiotomy, the duration of the second stage of labor, postpartum urinary incontinence, and neonatal outcomes between the two groups. The goal of the study is to evaluate whether pelvic floor training can improve maternal and neonatal birth outcomes.

Conditions

Perineal Trauma; Pelvic Floor Dysfunction; Labor Complications; Pelvic Floor Muscle Training

Keywords

Pelvic Floor Muscle Training; Perineal Trauma; Obstetric Anal Sphincter Injury; Vaginal Birth; Second Stage of Labor; Postpartum Urinary Incontinence; Antenatal Exercise Program

Outcome Measures

Primary Outcomes (1)

• Incidence of Severe Perineal Trauma (Grade 3-4)

  Severe perineal trauma is defined as third- or fourth-degree obstetric anal sphincter injuries (OASIS). Diagnosis is made by the attending clinician immediately after delivery using standard perineal examination and classification procedures.

  At delivery

Study Arms (2)

Pelvic Floor Training Program

EXPERIMENTAL

Participants in this arm received a structured antenatal pelvic floor muscle training program. The program included twice-weekly supervised PFMT sessions and a daily home-exercise routine from 20 to 34 weeks of gestation. Exercises consisted of sets of maximal voluntary pelvic floor contractions following a standardized protocol. Adherence was monitored through session attendance and weekly follow-up.

Behavioral: Pelvic Floor Muscle Training Program

Standard Antenatal Care

NO INTERVENTION

Participants in this arm received routine antenatal care with no structured pelvic floor muscle training program. They were followed throughout pregnancy and delivery according to standard clinical practice.

Interventions

Pelvic Floor Muscle Training Program BEHAVIORAL

A structured antenatal pelvic floor muscle training program consisting of twice-weekly supervised sessions and a daily home-exercise routine from 20 to 34 weeks of gestation. Sessions included repeated maximal voluntary pelvic floor contractions following a standardized protocol with progressive intensity. Adherence was monitored through attendance logs and weekly follow-up.

Also known as: Pelvic Floor Training

Pelvic Floor Training Program

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Nulliparous pregnant women aged 18 to 36 years
• Singleton pregnancy
• Gestational age of 28 weeks or greater at enrollment
• Low-risk pregnancy without known obstetric complications
• Planning a vaginal delivery
• Able and willing to participate in supervised exercise sessions

You may not qualify if:

• Multiple gestation
• Placenta previa or other contraindications to vaginal birth
• Preeclampsia or gestational hypertension
• Diabetes requiring medication
• History of pelvic floor or urogenital surgery
• Neurological disorders affecting continence or pelvic floor function
• Inability to attend regular training sessions
• Refusal to provide informed consent

Sponsors & Collaborators

• Mehmet Incebıyik: lead

Study Sites (1)

Harran University Research and Application Hospital

Şanliurfa, HALİLİYE, 63300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• MEHMET İNCEBIYIK, MD

  Harran University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors who evaluated perineal trauma and neonatal outcomes were blinded to the participants' group assignments. All other study personnel and participants were aware of group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Model Details: Participants were assigned to one of two parallel groups based on patient preference: a pelvic floor training group and a standard care control group. Both groups were followed concurrently throughout the study period.

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 18, 2025
• Study Start: December 2, 2024
• Primary Completion: September 2, 2025
• Study Completion: September 2, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)