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NCT Number: NCT07292948

Pelvic Floor Training Program and Perineal Trauma During Vaginal Birth

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.

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Key information

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Harran University Research and Application Hospital

Şanliurfa, HALİLİYE, 63300, Turkey (Türkiye)

About this study

This prospective, patient-preference controlled clinical trial was conducted to evaluate whether a structured antenatal pelvic floor muscle training (PFMT) program can reduce perineal trauma and improve maternal birth outcomes. Low-risk nulliparous pregnant women at 28 weeks of gestation or later were invited to participate. Women who chose to participate in the training program formed the intervention group, while those who declined received standard antenatal care and served as controls.

The intervention consisted of supervised PFMT sessions twice weekly, combined with a daily home-exercise program. Exercises followed a standardized protocol focusing on repeated maximal voluntary pelvic floor contractions with progressive increases in intensity. Adherence was monitored through attendance records and weekly follow-up.

The study assessed severe perineal trauma (third- or fourth-degree tears) as the primary outcome. Secondary outcomes included episiotomy rate, duration of the second stage of labor, postpartum urinary incontinence, and neonatal outcomes. All participants provided written informed consent, and the study was approved by the institutional ethics committee. The findings aim to inform whether structured PFMT should be incorporated into routine antenatal care to support maternal pelvic floor health and improve labor outcomes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Pelvic Floor Training

Primary outcomes

  1. Incidence of Severe Perineal Trauma (Grade 3-4)

    Time frame: At delivery

    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.

Sponsors and collaborators

Lead sponsor

Mehmet Incebıyik

Other

Registry information

Official study title

The Effect of a Pelvic Floor Training Program on Perineal Trauma During Birth: A Patient-Preference Controlled Clinical Trial

Acronym: PFTP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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