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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05355636
Other study ID # contraceptive counseling
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date December 1, 2022

Study information

Verified date March 2022
Source Marmara University
Contact Meltem Demirgöz BAL, prof.
Phone +902167775700
Email meltem.bal@marmara.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Fertility management refers to the entirety of practices that allow families to have as many children as they want and when they want, prevent unwanted pregnancies, regulate the time between two births and receive help in having children in the case of infertility. According to the Turkey Demographic and Health Survey 2018 data, 70% of women in Turkey who are currently married do not use any contraceptive method. Based on the same data, the rate of the unmet need for fertility management is 12% nationwide, 14% in eastern provinces, and 17% in women at the ages of 20-24. These rates show that the rates of unmet fertility management needs in Turkey are still not on the desired level. The fact that eastern provinces of Turkey have the lowest rate of modern contraceptive method use as 43% and a high rate of unmet fertility management needs as 14% suggests that it is needed to increase the effectiveness of fertility management counseling and reach more women. In these eastern provinces, especially women living in rural areas do not have easy access to these services due to the high prevalence of adolescent marriages, lack of transportation opportunities, healthcare personnel and healthcare services, and unpredictable weather conditions.


Description:

To eliminate these obstacles to a relative extent, fertility management counseling will be provided through using the telehealth method. The World Health Organization states that telehealth practices will make access easier, eliminate geographical obstacles, increase the quality of healthcare, and allow the cost-effective management of the resources of the healthcare sector. The telehealth system increases the quality of healthcare, and thus, it has a significant role in managing the resources of the healthcare sector. The Participant Information Form created by the researcher based on the review of the relevant literature includes questions about the sociodemographic characteristics of the participants (age, education level, employment status, income level) and pregnancy-related questions. The Contraceptive Method Usage Status Form (for the experimental and control groups) will be utilized to determine the contraceptive methods that are used by women in the 7th month of the postpartum period.The data that will be obtained in the study will be statistically analyzed using the International Business Machines Statistical Package for the Social Sciences Subscription Trial version. The analyses will include independent-samples t-test, ANOVA, and Cochran test. In cases of significant differences identified in ANOVA, Tukey's test will be used to identify the source of the difference in pairwise comparisons. The level of statistical significance is accepted as p<0.05.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date December 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - volunteer - be between the ages of 18-45 - to be primiparous - have a smart phone - complete education Exclusion Criteria: - refuse to research

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Fertility Management Counseling
counseling

Locations

Country Name City State
Turkey Duygu Tatar Bi?tli?s

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Telehealth on Contraceptive Use The use of birth control methods by the fertility regulation consultancy service offered by Telehealth in postpartum women is a positive indicator of counseling. 7 months
Primary Family Planning Method Using Status Form It is a scale that examines the method use status of the participants after telehealth assisted fertility regulation counseling. 7 months
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