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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05094518
Other study ID # HeraInc
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date December 1, 2022

Study information

Verified date October 2021
Source HERA Inc
Contact Aral Surmeli, MD
Phone +905353140179
Email a.surmeli@medak.org.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the effectiveness of mobile phone based appointment reminder notifications sent through Health Recording App (HERA) in increasing the uptake of 4 World Health Organization recommended prenatal visits among Syrian refugee population.


Description:

Background: 12 million Syrians have been forcibly displaced from their homes since the start of Syrian Civil War in 2011. Despite Turkey providing free healthcare services through national insurance to nearly 4 million refugees that it hosts, pregnant Syrian women are less likely to attend prenatal visits and more likely to die during and after labor. An increase in the uptake of prenatal care may improve quality of life through healthy pregnancies and safer labor conditions in this population with double vulnerability. Mobile phone-based reminders have been shown in randomized controlled trials and systematic reviews to increase the uptake of various services, including prenatal care. Mobile phone penetration is high among Syrian refugees in Turkey and qualitative studies demonstrate that mobile health interventions are acceptable and feasible for Syrian refugees. Primary objective: To evaluate the impact of mobile phone-based reminders on the uptake of prenatal care among pregnant Syrian refugee women. More specifically, the study assesses the effectiveness of mobile phone-based reminders by measuring the percent increase in the number of prenatal appointments attended by intervention arm participants compared to the control arm participants. Study design: This is a behavioral intervention study using an un-blinded, parallel groups, randomized controlled study design. Primary Outcome: The primary outcome of this study is the number of medical visits, following the initial baseline prenatal care visit, over the 6 month period prior to childbirth. Secondary outcomes: Secondary outcomes are based on the Sociodemographic and Health History form. The form gathers information about demographics of the participants (age, education, employment, marital status, number of children) and health history (previous pregnancies, delivery methods, miscarriages, stillborn, chronic conditions and medications. We will further examine these risk factors on the number of medical visits during the study period.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 162
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: - Having the status of "Syrian under temporary protection" - Being in the first trimester of the pregnancy - Initial prenatal visit - Age equal or greater than 18 years and less than or equal to 49 Exclusion Criteria: - Having a citizenship or a status other than "Syrian under temporary protection" - Not owning a mobile phone - Being unable to read and write - Not initial prenatal visit - Having a chronic disorder or high-risk pregnancy that requires the individual to go to the hospital frequently. Frequently is defined as more than 3 visits post the baseline visit. - While gestating, those that develop a high-risk pregnancy that requires more than 3 visits post the baseline visit.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mobile phone reminders
Appointment reminders in the form of push notifications will be sent through HERA app.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
HERA Inc Medical Rescue Association (MEDAK), Turkey

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of attendance for prenatal care visits The number of 4 mandatory prenatal care appointments that are attended are presented here. 6 months
Secondary Sociodemographic and Health information form data Data about sociodemographic and health information of participants will be presented here. 6 months
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