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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| MEHMET İNCEBIYIK, MD | Harran University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harran University Research and Application Hospital | Şanliurfa | HALİLİYE | 63300 | Turkey (Türkiye) |
Individual participant data will not be shared because the dataset contains identifiable maternal and neonatal information that cannot be publicly released under institutional ethics regulations and national data protection laws. Summary data may be provided upon reasonable request.
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| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
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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.
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