The Effect of a Pelvic Floor Training Program on Perineal Trauma During Birth: A Patient-Preference Controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mehmet Incebıyik
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Incidence of Severe Perineal Trauma (Grade 3-4)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 36 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mehmet Incebıyik
Assistant Professor of Obstetrics and Gynecology
Harran University