Obstetric Exercise and Maternal Outcomes in Pregnancy

NCT07170124 | Completed

• 1 other identifier: E-33117789-044-126827
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial will be conducted in the antenatal clinic and pregnancy school of a public hospital in eastern Türkiye. The study will aim to investigate the effects of obstetric exercises on depression, pregnancy-related complaints, and quality of life in women receiving prenatal care. A total of 100 pregnant women will be recruited and randomly assigned to either the intervention group (n=50) or the control group (n=50). The intervention group will participate in a four-week, physiotherapist-led, closely supervised obstetric exercise program, while the control group will continue to receive routine prenatal care. Data will be collected through a sociodemographic questionnaire, the Beck Depression Inventory (BDI), and the Pregnancy Symptoms Inventory (PSI). Post-intervention outcomes will be analyzed using independent-samples t-tests to compare groups, and multiple linear regression will be applied to determine the influence of sociodemographic factors on study variables. This study is expected to contribute to the evidence base by clarifying the potential role of obstetric exercise in reducing depressive symptoms, alleviating pregnancy complaints, and improving maternal quality of life within routine prenatal care settings.

Conditions

Depression During Pregnancy; Pregnancy; Pregnancy Complications

Keywords

Obstetric exercise; Depression; Pregnancy symptoms; Quality of life

Outcome Measures

Primary Outcomes (2)

• Change in Depression Symptoms Assessed by BDI

  The Beck Depression Inventory (BDI) is a 21-item self-report scale measuring depressive symptoms. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 63. Higher scores indicate more severe depressive symptoms (0-13 minimal, 14-19 mild, 20-28 moderate, 29-63 severe). The mean change in BDI total score from baseline to post-intervention will be compared between groups.

  At enrollment

• Change in Pregnancy-Related Complaints Assessed by PSI

  Pregnancy Symptoms Inventory (PSI): The scale consists of 42 items assessing the frequency of symptoms commonly experienced during pregnancy (e.g., fatigue, nausea, vomiting, reflux, constipation, dry mouth, cravings, insomnia). Each item is rated for frequency (0=never to 3=often) and limitation (0=not at all to 3=quite a lot). Higher scores indicate greater frequency and severity of complaints. The mean change in PSI total score from baseline to post-intervention will be compared between groups.

  At enrollment

Secondary Outcomes (2)

• Change in Depression Symptoms Assessed by BDI

  At baseline and immediately post-intervention (4 weeks)

• Change in Pregnancy-Related Complaints Assessed by PSI

  At baseline and immediately post-intervention (4 weeks)

Study Arms (2)

Exercise group

EXPERIMENTAL

Participants in the intervention group will take part in a four-week obstetric exercise program designed specifically for pregnant women. The program will be led by a licensed physiotherapist and delivered in small group sessions at the hospital's pregnancy school. Exercises will focus on relaxation, breathing techniques, stretching, posture correction, and low-impact strengthening movements appropriate for pregnancy. Sessions will be closely supervised to ensure safety and adapted to each participant's gestational stage and physical capacity. In addition to routine prenatal care, participants in this group will receive structured, physiotherapist-led exercise sessions once a week for four weeks.

Other: Obstetric exercises

Control group

NO INTERVENTION

Participants in the control group will receive routine prenatal care provided by the hospital's antenatal clinic and pregnancy school. This includes standard obstetric follow-up, regular health check-ups, and educational counseling typically offered during pregnancy, but no structured obstetric exercise program.

Interventions

Obstetric exercises OTHER

The intervention will consist of a structured obstetric exercise program administered by a physiotherapist who is permanently employed at the hospital's prenatal education center, ensuring the reliability and standardization of the intervention. The program will be based on the "Pregnancy and Exercise Guide" (2012) published by the Turkish Ministry of Health and will be delivered in the pregnancy school of a public hospital in eastern Türkiye. The exercises will be provided at weekly intervals and will include: Active joint movements to improve mobility and maintain functional range of motion, Stretching exercises to enhance flexibility and alleviate musculoskeletal discomfort, Calisthenic bodyweight exercises to promote muscle strength and endurance, Relaxation and breathing techniques to reduce stress and improve maternal well-being.

Exercise group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 45 years
• Low-risk singleton pregnancy confirmed by ultrasound
• No chronic illness
• No psychiatric disorder
• No physical disability
• Voluntary agreement to participate in the study
• Gestational age between 28 and 42 weeks (third trimester)

You may not qualify if:

• Body mass index (BMI) ≥ 40 kg/m² or ≤ 18 kg/m²
• Concurrent participation in another exercise or psychosocial intervention study
• Failure to attend at least one exercise session

Sponsors & Collaborators

• Bingol University: lead

Study Sites (1)

Bingöl State Hospital

Bingöl, Bingöl, 12000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pregnancy Complications; Depression

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavioral Symptoms; Behavior

Study Officials

• Mehmet Kaplan, Ph.D.

  Bingol University

  PRINCIPAL INVESTIGATOR

• Mesut Çelik, Ph.D.

  Bingol University

  STUDY DIRECTOR

• Gülcan Çelik, Bachelor's Degree

  Bingöl State Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: A randomized controlled trial

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 12, 2025
• Study Start: December 20, 2024
• Primary Completion: June 20, 2025
• Study Completion: August 15, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)