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Family Planning ServicesNCT05743309

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

A study testing Video call sessions in people with Family Planning Services and Telemedicine, run by Fenerbahce University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
What is being tested?
Video call sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2021to 15 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Fenerbahce University

    Istanbul, Atasehir

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Being tested
Video call sessions
Keywords
Family Planning Services, Telemedicine, Pregnant Women, Women's Health, COVID-19 Pandemic
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video call sessionsBehavioural

    Investigators made video call sessions with the participants.

Study groups in NCT05743309
Study groupRoleWhat they receive
Telemedicine PracticesExperimentalIn this study, telemedicine practices stand for video call sessions used for contraceptive counseling services.
Receives: Behavioral: Video call sessions
Routine Contraceptive Counseling ServicesNo interventionParticipants in the control group received only routine contraceptive counseling services provided by primary health care settings.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2023
  2. Study start1 Jan 2021
  3. Primary completion15 Jun 2021
  4. Study completion15 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05743309
Sponsor's protocol ID
FenerbahçeU
Status last verified
Feb 2023
First submitted
22 Feb 2023
Last updated
24 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 34400152

  • 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.

    PubMed 33212033

  • 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.

    PubMed 32059840

  • 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.

    PubMed 35594989

  • 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.

    PubMed 36060498

  • 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.

    PubMed 33861981

  • 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.

    PubMed 33599196

  • 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.

    PubMed 35766699

  • 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.

    PubMed 34058421

  • 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.

    PubMed 36759838

  • 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.

    PubMed 34483512

Questions about this trial

What is this clinical trial studying?

A study testing Video call sessions in people with Family Planning Services and Telemedicine, run by Fenerbahce University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05743309, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.

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