NCT05743309

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 22, 2023

Last Update Submit

February 22, 2023

Conditions

Keywords

Family Planning ServicesTelemedicinePregnant WomenWomen's HealthCOVID-19 Pandemic

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Telemedicine Practices

EXPERIMENTAL

In this study, telemedicine practices stand for video call sessions used for contraceptive counseling services.

Behavioral: Video call sessions

Routine Contraceptive Counseling Services

NO INTERVENTION

Participants in the control group received only routine contraceptive counseling services provided by primary health care settings.

Interventions

Investigators made video call sessions with the participants.

Telemedicine Practices

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women in the third trimester of their pregnancy and who agreed to participate in the study have been included in this study.

You may not qualify if:

  • Women with psychiatric disorder have been excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fenerbahce University

Istanbul, Atasehir, Turkey (Türkiye)

Location

Related Publications (11)

  • 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants did not know which group they were assigned to.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: In this study, there are two groups (one experimental and one control group). While experimental group patients received telemedicine practices related to Family planning, control group patients received only routine health services provided by primary health care setting.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 22, 2023

First Posted

February 24, 2023

Study Start

January 1, 2021

Primary Completion

June 15, 2021

Study Completion

June 15, 2021

Last Updated

February 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations