Evaluation of Telemedicine Practices for Contraceptive Counseling During the COVID-19 Pandemic: A Randomized Controlled Trial

COVID-19 Pandemic Clinical Trial

Official title:

Evaluation of Telemedicine Practices for Contraceptive Counseling Given to Pregnant Women During the COVID-19 Pandemic: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05743309
• Other study ID #: FenerbahçeU
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 15, 2021

Study information

• Verified date: February 2023
• Source: Fenerbahce University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic
• Family Planning Services
• Pregnant Women
• Telemedicine
• Women's Health

Intervention

Behavioral:
• Video call sessions
Investigators made video call sessions with the participants.

Locations

Country	Name	City	State
Turkey	Fenerbahce University	Istanbul	Atasehir

Sponsors (1)

Lead Sponsor	Collaborator
Fenerbahce University

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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; — View Citation

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 202 — View Citation

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.contra — View Citation

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 — View Citation

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.cont — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Primary outcome	6 Months