RecruitingNot Applicable

Development of Post-Disaster Care Protocol for Pregnant Women and Evaluation of Its Effectiveness

Turkey (Türkiye)43 participantsStarted 2025-03-09

Plain-language summary

It was designed as a randomized controlled experimental study to determine whether the care protocol planned for pregnant women in the disaster area positively affects their physical and psychological health.

Who can participate

Age range

19 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Over the age of 18, * Positive (+) pregnancy, * Able to read and write Turkish and speak and understand Turkish, * No mental or psychological disorder that would cause difficulty in expressing oneself, * Not receiving a score between 20-27 (severe depression) on HSA-9, * No chronic disease or high-risk pregnancy diagnosis requiring hospitalization and follow-up, * Volunteer to participate in the study Exclusion Criteria: * Under 18 years of age, * Foreign nationals who cannot read or write Turkish and are inadequate in speaking or understanding Turkish, * Those with any mental or psychological disorder/diagnosis, * Those who score between 20-27 (severe depression) on HSA-9, * Those with a chronic disease or a diagnosis of high-risk pregnancy requiring hospitalization and follow-up, * Those who do not agree to participate in the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determining patient health level

Timeframe: The first data will be collected up to the 16th week of pregnancy, the second data between the 36th and 38th weeks, and the last data between the 4th and 8th weeks postpartum.

Determining the level of psychosocial health during pregnancy

Timeframe: The first data will be collected up to the 16th week of pregnancy, the second data between the 36th and 38th weeks.

Determining the level of trauma after an earthquake

Timeframe: The first data will be collected up to the 16th week of pregnancy, the second data between the 36th and 38th weeks, and the last data between the 4th and 8th weeks postpartum.

Determining the level of postpartum depression

Timeframe: The data will be collected between the 4th and 8th weeks postpartum.

Trial details

NCT IDNCT07058766

SponsorSakarya University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-15

Contact for this trial

Döndü SEVİMLİ GÜLER, Dr. Lecturer

+905057736638 donduguler@subu.edu.tr

View on ClinicalTrials.gov More Earthquake trials

Who can participate

Age range

19 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Determining patient health level

Timeframe: The first data will be collected up to the 16th week of pregnancy, the second data between the 36th and 38th weeks, and the last data between the 4th and 8th weeks postpartum.

Determining the level of psychosocial health during pregnancy

Timeframe: The first data will be collected up to the 16th week of pregnancy, the second data between the 36th and 38th weeks.

Determining the level of trauma after an earthquake

Timeframe: The first data will be collected up to the 16th week of pregnancy, the second data between the 36th and 38th weeks, and the last data between the 4th and 8th weeks postpartum.

Determining the level of postpartum depression

Timeframe: The data will be collected between the 4th and 8th weeks postpartum.