- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05355636
The Effects of Fertility Management Counseling Supported With Telehealth on Contraceptive Use
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Meltem Demirgöz BAL, prof.
- Phone Number: 5721 +902167775700
- Email: meltem.bal@marmara.edu.tr
Study Contact Backup
- Name: duygu tatar, MsC Student
- Phone Number: +905395788652
- Email: dygalan34@gmail.com
Study Locations
-
-
-
Bi̇tli̇s, Turkey, 13000
- Duygu Tatar
-
Contact:
- duygu tatar
- Phone Number: +905395788652
- Email: dygalan34@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experiment group
patient receiving counseling
|
counseling
|
|
No Intervention: control group
patient without counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Telehealth on Contraceptive Use
Time Frame: 7 months
|
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
|
|
Family Planning Method Using Status Form
Time Frame: 7 months
|
It is a scale that examines the method use status of the participants after telehealth assisted fertility regulation counseling.
|
7 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: duygu tatar, MsC Student, Marmara University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- contraceptive counseling
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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