Pelvic Floor Training Program and Perineal Trauma During Vaginal Birth (PFTP)

Mehmet Incebıyik

Status: Completed

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

Treatments: Behavioral: Pelvic Floor Muscle Training Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07292948

HU-PFTP-PERINEAL-TRAUMA-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Pelvic Floor Training Program

Experimental group

Description:

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.

Treatment:

Behavioral: Pelvic Floor Muscle Training Program

Standard Antenatal Care

No Intervention group

Description:

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.