An interventional study of Integrated Family Planning Services in Contraception, sponsored by Indiana University. Completed. Open to female participants aged 14 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by Indiana University · Not applicable, Interventional, and Treatment
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.
The investigators' hypothesis is that implementation of an educational intervention emphasizing long-acting reversible contraception (LARC) combined with free on-site provision of LARC within Anticoagulation Monitoring Service (AMS) can improve uptake of these methods by 250% in this population.
Our objectives are to:
The investigators will perform a prospective cohort study of all women of reproductive age seen in Anticoagulation Monitoring Service (AMS). 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 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. During the intervention period we intend to capture all women currently actively enrolled in AMS, which is currently approximately 400 women. Each woman generally attends AMS clinic once per month, so the investigators expect that it will take about three months to capture all women at least once. These women will then be followed prospectively over the next one-year time period to evaluate for uptake of a contraceptive method and subsequent pregnancy. The investigators will then compare participants' method of contraception used prior to the intervention and participants' method of contraception used after the intervention. The investigators will specifically evaluate for an increase in the use of IUCDs and contraceptive implants.
Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Percent of women who have initiated the use of contraception
Proportion of women who initiated contraception after study enrollment
Time frame: 3 months Post-intervention
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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