- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02773810
Integration of Family Planning Services Into Anticoagulation Monitoring Services
Can Integration of Family Planning Services Into Anticoagulation Monitoring Services Improve Uptake of Long-Acting Reversible Contraception?
연구 개요
상세 설명
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:
- Determine whether integration of education about and free provision of highly effective long-acting reversible contraceptive methods within Anticoagulation Monitoring Services (AMS) is feasible.
- Determine whether integration of education about and free provision of highly effective long-acting reversible contraceptive methods within Anticoagulation Monitoring Services (AMS) can improve uptake of long-acting reversible contraceptive methods (IUCDs and contraceptive implants).
- Determine whether integration of education about and free provision of highly effective long-acting reversible contraceptive methods within an Anticoagulation Monitoring Services (AMS) Clinic can prevent unplanned pregnancies.
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.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- All women of reproductive age (age 14 to 50 or menopause) actively enrolled in Anticoagulation Monitoring Service (AMS) during the study timeframe.
Exclusion Criteria:
- Women who are pregnant.
- Women who have had a hysterectomy.
- Women who do not speak Kiswahili.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Percent of women who have initiated the use of contraception
기간: 3 months Post-intervention
|
Proportion of women who initiated contraception after study enrollment
|
3 months Post-intervention
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Caitlin Bernard, MD, Indiana University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 1504431629
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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Integrated Family Planning Services에 대한 임상 시험
-
Maureen LyonNational Institute of Mental Health (NIMH)완전한