Obstetric Exercise and Maternal Outcomes in Pregnancy

NCT ID: NCT07170124

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-20
• Study Completion Date: 2025-08-15

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.

Detailed Description

This randomized controlled trial is designed to evaluate the effectiveness of a structured obstetric exercise program on maternal mental health and pregnancy-related outcomes. The study will be conducted in the antenatal clinic and pregnancy school of a public hospital in eastern Türkiye, with a total of 100 pregnant women enrolled. Participants will be randomly allocated into two parallel groups: an intervention group (n=50) and a control group (n=50). Randomization will be performed using a computer-generated allocation sequence to minimize selection bias.

The intervention consists of a four-week exercise program developed specifically for pregnant women, led and closely supervised by a physiotherapist trained in maternal health. Sessions will take place three times per week, each lasting approximately 45-60 minutes, and will include a combination of breathing exercises, stretching, posture training, and low-intensity strengthening movements adapted for pregnancy. Exercise intensity and duration will be progressively adjusted according to gestational age, maternal comfort, and current obstetric guidelines. To ensure safety, maternal vital signs and fetal well-being will be monitored before and after each session. Participants will also receive verbal instructions on safe daily activity modifications and home practice recommendations.

The control group will receive standard prenatal care provided by the antenatal clinic, without additional structured exercise training. Both groups will continue to have access to routine obstetric monitoring, counseling, and educational materials typically offered by the hospital's pregnancy school.

Primary data will be collected using validated self-report instruments:

Beck Depression Inventory (BDI): to assess depressive symptoms. Pregnancy Symptoms Inventory (PSI): to evaluate frequency and severity of common pregnancy-related complaints.

Sociodemographic Questionnaire: to capture baseline characteristics such as age, education, employment, and income.

Outcome assessments will be conducted at baseline (prior to randomization) and immediately after completion of the four-week program. Data analysis will include independent-samples t-tests to assess between-group differences in outcome measures. Multiple linear regression models will be applied to determine the potential influence of sociodemographic and clinical variables on depressive symptoms, pregnancy complaints, and quality of life scores. Statistical significance will be set at p<0.05.

Ethical approval has been obtained from the relevant institutional review board, and written informed consent will be secured from all participants prior to enrollment. All procedures will comply with the principles of the Declaration of Helsinki.

This study aims to provide more robust evidence on the contribution of physiotherapist-led obstetric exercise programs to maternal health. By focusing on depression, pregnancy-related complaints, and quality of life, the results are expected to inform clinical practice guidelines and support the integration of safe exercise interventions into routine prenatal care in Türkiye and similar healthcare contexts.

Conditions

Depression During Pregnancy; Pregnancy; Pregnancy Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Exercise group

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.

Group Type: EXPERIMENTAL

Obstetric exercises

Intervention Type: 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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Obstetric exercises

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bingol University

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Kaplan

Asst. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet Kaplan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Bingol University

Mesut Çelik, Ph.D.

Role: STUDY_DIRECTOR

Bingol University

Gülcan Çelik, Bachelor's Degree

Role: STUDY_CHAIR

Bingöl State Hospital

Locations

Bingöl State Hospital

Bingöl, Bingöl, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-33117789-044-126827

Identifier Type: -

Identifier Source: org_study_id