- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05743309
Evaluation of Telemedicine Practices for Contraceptive Counseling During the COVID-19 Pandemic: A Randomized Controlled Trial
Evaluation of Telemedicine Practices for Contraceptive Counseling Given to Pregnant Women During the COVID-19 Pandemic: A Randomized Controlled Trial
The goal of this randomized clinical trial is to evaluate the telemedicine practices for contraceptive counseling given to pregnant women during the COVID-19 pandemic. The main questions it aims to answer are:
- Does family planning counseling given to pregnant women by using telemedicine practices have an effect on the knowledge level about family planning?
- Is family planning counseling given to pregnant women by using telemedicine practices effective on satisfaction with family planning services? Participants have attended to contraceptive counseling video call sessions provided via WhatsApp application and they have the opportunity to see the consultant and her materials during these sessions. After these sessions (two weeks later), contraceptive counseling video call session has been repeated, and at the end of this second session, women have been asked to answer the questions in the "Family Planning Knowledge Level Form" and the "Family Planning Services Satisfaction Scale". There is a comparison group (a control group) in this study, and no intervention was made to the women in the control group other than the routine services given in primary care settings.
Researchers will compare the experimental group with control group to see if the telemedicine practices are effective in increasing the knowledge level of pregnant women about family planning and in the satisfaction of family planning services provided by primary health care settings.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Atasehir
-
Istanbul, Atasehir, Turkey
- Fenerbahçe University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women in the third trimester of their pregnancy and who agreed to participate in the study have been included in this study.
Exclusion Criteria:
- Women with psychiatric disorder have been excluded from this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telemedicine Practices
In this study, telemedicine practices stand for video call sessions used for contraceptive counseling services.
|
Investigators made video call sessions with the participants.
|
|
No Intervention: Routine Contraceptive Counseling Services
Participants in the control group received only routine contraceptive counseling services provided by primary health care settings.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Family planning counseling given to pregnant women by using telemedicine practices have an effect on the knowledge level about family planning and on the satisfaction with family planning services.
Time Frame: 6 Months
|
Primary outcome
|
6 Months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Steenland MW, Geiger CK, Chen L, Rokicki S, Gourevitch RA, Sinaiko AD, Cohen JL. Declines in contraceptive visits in the United States during the COVID-19 pandemic. Contraception. 2021 Dec;104(6):593-599. doi: 10.1016/j.contraception.2021.08.003. Epub 2021 Aug 14.
- Stifani BM, Avila K, Levi EE. Telemedicine for contraceptive counseling: An exploratory survey of US family planning providers following rapid adoption of services during the COVID-19 pandemic. Contraception. 2021 Mar;103(3):157-162. doi: 10.1016/j.contraception.2020.11.006. Epub 2020 Nov 17.
- Martinez KA, Rastogi R, Lipold L, Rothberg MB. Response to requests for contraception in one direct-to-consumer telemedicine service. Contraception. 2020 May;101(5):350-352. doi: 10.1016/j.contraception.2020.01.017. Epub 2020 Feb 12.
- Stifani BM, Madden T, Micks E, Moayedi G, Tarleton J, Benson LS. Society of Family Planning Clinical Recommendations: Contraceptive Care in the Context of Pandemic Response. Contraception. 2022 Sep;113:1-12. doi: 10.1016/j.contraception.2022.05.006. Epub 2022 May 18.
- Huang I, Delay R, Boulware A, McHugh A, Wong ZJ, Whitaker AK, Stulberg D, Hasselbacher L. Telehealth for contraceptive care: Lessons from staff and clinicians for improving implementation and sustainability in Illinois. Contracept X. 2022 Aug 14;4:100083. doi: 10.1016/j.conx.2022.100083. eCollection 2022.
- Stifani BM, Smith A, Avila K, Boos EW, Ng J, Levi EE, Benfield NC. Telemedicine for contraceptive counseling: Patient experiences during the early phase of the COVID-19 pandemic in New York City. Contraception. 2021 Sep;104(3):254-261. doi: 10.1016/j.contraception.2021.04.006. Epub 2021 Apr 20.
- Mickler AK, Carrasco MA, Raney L, Sharma V, May AV, Greaney J. Applications of the High Impact Practices in Family Planning during COVID-19. Sex Reprod Health Matters. 2021 Dec;29(1):1881210. doi: 10.1080/26410397.2021.1881210.
- Karaahmet AY, Bilgic FS. COVID-19: the unmet need for family planning and its effects on sexuality: a cross-sectional study. Rev Assoc Med Bras (1992). 2022 Jun 24;68(6):827-832. doi: 10.1590/1806-9282.20220138. eCollection 2022.
- Miller HE, Henkel A, Leonard SA, Miller SE, Tran L, Bianco K, Shaw KA. The impact of the COVID-19 pandemic on postpartum contraception planning. Am J Obstet Gynecol MFM. 2021 Sep;3(5):100412. doi: 10.1016/j.ajogmf.2021.100412. Epub 2021 May 28.
- Sileo KM, Muhumuza C, Helal T, Olfers A, Lule H, Sekamatte S, Kershaw TS, Wanyenze RK, Kiene SM. Exploring the effects of COVID-19 on family planning: results from a qualitative study in rural Uganda following COVID-19 lockdown. Reprod Health. 2023 Feb 9;20(1):31. doi: 10.1186/s12978-023-01566-3.
- Krishna UR. Reproductive Health During the COVID-19 Pandemic. J Obstet Gynaecol India. 2021 Aug;71(Suppl 1):7-11. doi: 10.1007/s13224-021-01546-2. Epub 2021 Aug 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- FenerbahçeU
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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