NCT07575490

Brief Summary

This study aims to investigate the effects of a specific exercise program on physical recovery and sexual health in women who have had a cesarean section. Pregnancy and abdominal surgery can lead to a separation of the abdominal muscles, known as Diastasis Recti Abdominis (DRA), and may affect pelvic health and sexual function. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will participate in a 6-week "Structured Abdomino-Pelvic Power-Training" program starting at the 6th week after surgery. This program includes specific exercises to strengthen the core and pelvic floor muscles. The control group will follow the standard routine postpartum care. The researchers will use ultrasound and Doppler imaging to measure the distance between the abdominal muscles and the blood flow in the pelvic area at the beginning of the study and after 6 weeks of training. Participants will also complete a validated questionnaire (FSFI) to evaluate their sexual function. The goal of the research is to determine if this structured exercise program helps close the abdominal gap more effectively and improves pelvic blood flow and sexual well-being compared to standard care.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
May 2026Dec 2026

Study Start

First participant enrolled

May 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 2, 2026

Last Update Submit

May 2, 2026

Conditions

Keywords

Vaginal DopplerPelvic HemodynamicsAbdomino-pelvic TrainingFSFI (Female Sexual Function Index)Post-cesarean RecoveryCore StabilizationUterine Artery Doppler

Outcome Measures

Primary Outcomes (1)

  • Change in Inter-recti Distance (IRD)

    The distance between the medial borders of the two rectus abdominis muscles, measured in centimeters (cm) using linear probe ultrasonography to evaluate the severity of Diastasis Recti Abdominis (DRA).

    From baseline (6th week postpartum) to the completion of the exercise program (3rd month postpartum).

Study Arms (2)

Intervention Group: Abdomino-Pelvic Power-Training

EXPERIMENTAL

Participants in this arm will participate in a 6-week "Structured Abdomino-Pelvic Power-Training" program, starting at the 6th week postpartum. The intervention consists of: Clinical Sessions: Once-a-week supervised training sessions conducted at the hospital to ensure correct technique. Home Exercise Program: Prescribed daily exercises to be performed by the participant at home for the remaining 6 days of the week. Core Stabilization: Specific exercises targeting the rectus abdominis, obliques, and transversus abdominis muscles to reduce inter-recti distance (IRD). Pelvic Floor Muscle Training (PFMT): Structured contractions aimed at improving pelvic floor strength and hemodynamics. Monitoring: Progress will be monitored during weekly clinical visits, and the intensity will be adjusted based on participant tolerance.

Other: Abdomino-Pelvic Power-Training Program

Control Group: Standard Postpartum Care

ACTIVE COMPARATOR

Participants in this arm will follow the standard routine postpartum care and follow-up protocol provided by the clinic. They will not participate in the structured abdomino-pelvic or pelvic floor exercise program during the 6-week study period. All clinical assessments, including ultrasound measurements for inter-recti distance, pelvic Doppler imaging, and the Female Sexual Function Index (FSFI) questionnaires, will be performed at the same time intervals as the intervention group (at the 6th week and 3rd month postpartum) to provide a comparative baseline for the study.

Other: Standard Postpartum Follow-up

Interventions

A 6-week structured exercise program including one weekly supervised clinical session and daily home exercises. It focuses on core stabilization (rectus abdominis, obliques, transversus abdominis) to reduce inter-recti distance and Pelvic Floor Muscle Training (PFMT) to improve strength and hemodynamics.

Intervention Group: Abdomino-Pelvic Power-Training

Participants will follow the routine clinical postpartum follow-up protocol. This includes standard medical advice and assessments at the 6th week and 3rd month postpartum, without participation in the structured exercise program.

Control Group: Standard Postpartum Care

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women who have undergone an elective cesarean section.
  • Participants who are at their 6th week postpartum at the start of the study.
  • Aged between 18 and 45 years.
  • Volunteering to participate and capable of signing the informed consent form.

You may not qualify if:

  • Multiparous women (those with more than one delivery).
  • Women with a history of previous abdominal or pelvic surgery (other than the current C-section).
  • Presence of chronic diseases (e.g., uncontrolled diabetes, hypertension, or connective tissue disorders).
  • Any musculoskeletal or neurological condition that prevents participation in an exercise program.
  • History of pelvic organ prolapse or severe urinary incontinence prior to pregnancy.
  • Active pelvic or abdominal infection.
  • Participants who have already started a structured postpartum exercise program elsewhere.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harran University Research and Application Hospital

Sanliurfa, HALİLİYE, 63300, Turkey (Türkiye)

Location

Harran University Research and Application Hospital

Şanliurfa, HALİLİYE, 63300, Turkey (Türkiye)

Location

Central Study Contacts

MEHMET İNCEBIYIK, MD, Asst. Prof.

CONTACT

ismail palalı, PhD, Asst. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The primary investigator and the radiologist (outcomes assessor) performing the ultrasonographic measurements and Doppler evaluations will be blinded to the group assignments of the participants. To ensure effective masking, the participant will be instructed not to disclose their involvement in the exercise program to the assessor during the clinical follow-up and measurement sessions. Data analysis will be conducted by a statistician who is also masked to the allocation groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Model Description This is a prospective, two-arm, parallel-group randomized controlled trial. Randomization: Participants who meet the inclusion criteria will be randomly assigned to either the Intervention Group or the Control Group with a 1:1 allocation ratio. Randomization will be performed using a computer-generated random sequence to ensure unbiased distribution. Intervention Arm: Participants in this group will undergo a 6-week "Structured Abdomino-Pelvic Power-Training" protocol. This includes core stabilization and pelvic floor muscle exercises, initiated at the 6th week postpartum. Control Arm: Participants in this group will receive standard postpartum care and follow-up without any structured exercise intervention. Follow-up: Both groups will be evaluated at baseline (6th week postpartum) and immediately following the 6-week study period (3rd month postpartum) to compare clinical, morphometric, and hemodynamic outcomes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, MD

Study Record Dates

First Submitted

May 2, 2026

First Posted

May 8, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

To protect the privacy of the participants and ensure data confidentiality in accordance with the institutional ethical guidelines, individual participant data (IPD) will not be made publicly available. The study involves sensitive clinical measurements and personal health information that were collected under the condition of strict anonymity. Results will be disseminated through aggregated data in peer-reviewed publications.

Locations