Perineal TraumaPFTPNCT07292948
Pelvic Floor Training Program and Perineal Trauma During Vaginal Birth
A study testing Pelvic Floor Muscle Training Program in people with Perineal Trauma and Pelvic Floor Dysfunction, run by Mehmet Incebıyik at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineal Trauma, Pelvic Floor Dysfunction, Labor Complications
- What is being tested?
- Pelvic Floor Muscle Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2024to 2 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Harran University Research and Application Hospital
Şanliurfa, HALİLİYE, 63300
About this study
Official title: The Effect of a Pelvic Floor Training Program on Perineal Trauma During Birth: A Patient-Preference Controlled Clinical Trial
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.
Read the 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
- Being tested
- Pelvic Floor Muscle Training Program
- Keywords
- Pelvic Floor Muscle Training, Perineal Trauma, Obstetric Anal Sphincter Injury, Vaginal Birth, Second Stage of Labor, Postpartum Urinary Incontinence, Antenatal Exercise Program
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle Training ProgramBehavioural
Also called Pelvic Floor Training
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Pelvic Floor Muscle Training Program |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start2 Dec 2024
- Primary completion2 Sep 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Incebıyik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehmet Incebıyik, Harran University
- Investigators
- MEHMET İNCEBIYIK, MD, Study director, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292948
- Sponsor's protocol ID
- HU-PFTP-PERINEAL-TRAUMA-2025
- Acronym
- PFTP
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Pelvic Floor Training Program on Perineal Trauma During Birth: A Patient-Preference Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07292948
- Acronym / sponsor ID
- PFTP / HU-PFTP-PERINEAL-TRAUMA-2025
- 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 type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Mehmet IncebıyikUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 2 Sep 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Training Program | Experimental | Behavioral: Pelvic Floor Muscle Training ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Multiple gestation
- Placenta previa or other contraindications to vaginal birth
- Preeclampsia or gestational hypertension
- Diabetes requiring medication
- History of pelvic floor or urogenital surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Floor Muscle Training ProgramAlso: Pelvic Floor TrainingA 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. | Behavioural | Pelvic Floor Training Program |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No. 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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Ward-Level Implementation and Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice
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THE EFFECT OF 360° VIDEO-ASSISTED TRAINING ON VERTICAL BIRTH POSITIONS IN PRIMIPAROUS WOMEN ON FEAR OF CHILDBIRTH, SELF-EFFICACY IN CHILDBIRTH, SATISFACTION WITH CHILDBIRTH, AND PERINEAL TRAUMA: A RANDOMIZED CONTROLLED TRIAL
Childbirth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MEHMET İNCEBIYIK, MD study director
Harran University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Muscle Training Program in people with Perineal Trauma and Pelvic Floor Dysfunction, run by Mehmet Incebıyik at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Severe Perineal Trauma (Grade 3-4) (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.