Pelvic Floor Training Program and Perineal Trauma During Vaginal Birth

NCT ID: NCT07292948

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-02
• Study Completion Date: 2025-09-02

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.

Detailed Description

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Pelvic Floor Training Program

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.

Group Type: EXPERIMENTAL

Pelvic Floor Muscle Training Program

Intervention Type: 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.

Standard Antenatal Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pelvic Floor Muscle Training Program

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Pelvic Floor Training

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mehmet Incebıyik

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Incebıyik

Assistant Professor of Obstetrics and Gynecology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

MEHMET İNCEBIYIK, MD

Role: STUDY_DIRECTOR

Harran University

Locations

Harran University Research and Application Hospital

Şanliurfa, HALİLİYE, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HU-PFTP-PERINEAL-TRAUMA-2025

Identifier Type: -

Identifier Source: org_study_id