Integration of Family Planning Services Into Anticoagulation Monitoring Services

NCT02773810 | Completed

• 1 other identifier: 1504431629
• Study Type: interventional
• Target: 218
• Locations: 0 countries
• Sites: N/A

Brief Summary

Currently there are approximately 400 women of reproductive age enrolled in outpatient monitoring of warfarin therapy through AMS. The investigators do not have any data on the percentage of women who are using family planning, but anecdotally the providers report that it is very low. The investigators believe that an educational intervention with an emphasis on the safest and most effective methods, long-acting reversible contraception (LARC), aimed specifically toward women with medical conditions requiring anticoagulation, combined with on-site provision of LARC can improve uptake of these methods. Ultimately, the use of the most effective methods of contraception will prevent unplanned pregnancy and the unnecessary maternal morbidity and mortality associated with high-risk pregnancies in women with these conditions.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Percent of women who have initiated the use of contraception

  Proportion of women who initiated contraception after study enrollment

  3 months Post-intervention

Study Arms (1)

Integrated Family Planning Services

EXPERIMENTAL

Women who agree to enrollment will undergo our intervention, which will include an educational intervention and free on-site provision of all reversible contraceptive options, including LARC. This educational 5 intervention will be a one-on-one educational session on all available methods of contraception, with an emphasis on the safety and efficacy of long-acting reversible contraception (LARC) and the importance of planning a pregnancy in women with medical conditions requiring anticoagulation. A provider (clinic officer, nurse or physician) trained in family planning counseling and provision will provide all counseling and discussions in Kiswahili. Women will then be offered free, on-site provision of whichever contraceptive method they choose by a trained provider.

Other: Integrated Family Planning Services

Interventions

Integrated Family Planning Services OTHER

Women who agree to enrollment will undergo our intervention, which will include an educational intervention and free on-site provision of all reversible contraceptive options, including LARC. This educational 5 intervention will be a one-on-one educational session on all available methods of contraception, with an emphasis on the safety and efficacy of long-acting reversible contraception (LARC) and the importance of planning a pregnancy in women with medical conditions requiring anticoagulation. A provider (clinic officer, nurse or physician) trained in family planning counseling and provision will provide all counseling and discussions in Kiswahili. Women will then be offered free, on-site provision of whichever contraceptive method they choose by a trained provider.

Integrated Family Planning Services

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All women of reproductive age (age 14 to 50 or menopause) actively enrolled in Anticoagulation Monitoring Service (AMS) during the study timeframe.

You may not qualify if:

• Women who are pregnant.
• Women who have had a hysterectomy.
• Women who do not speak Kiswahili.

Sponsors & Collaborators

• Indiana University: lead
• University of Toronto: collaborator

Study Officials

• Caitlin Bernard, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Volunteer Clinical Assistant Professor

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 16, 2016
• Study Start: April 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share