- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01199952
RCT: Can a Single Counseling Phone Call Improve Contraception After an Abortion? (PPR)
A Randomized Controlled Trial: Contraceptive Counseling After an Abortion
Hypothesis: Use of an effective contraceptive six weeks after abortion will be higher in the treatment group than in the control group.
Primary Aim ·To determine use of an effective contraceptive method six weeks after abortion in women who choose combined hormonal contraception (CHC) and who receive a three-week educational phone call as compared to women who do not receive the intervention.
Secondary Aims
- To describe the most common concerns and logistical problems women experience with initiating and adhering to CHC after abortion.
- To describe the concerns that lead to discontinuation or method change. *To assess feasibility of conducting a follow-up telephone call in this population This is a randomized, controlled trial to assess the effect of a three-week follow-up phone call in women who choose combined hormonal contraception on the day of their abortion at the San Francisco General Hospital Women's Options Center. Subjects randomized to the treatment group will receive an interventional phone call three weeks after their abortion; participants randomized to the control group will not receive the call. All subjects will receive a follow-up call six weeks after their abortion to assess and compare method use between the two groups. Calls will be made at three- and six-weeks post abortion in order to give subjects enough time to initiate CHC and to assess continuation into the second month of the method. Data will be collected at baseline, during the intervention for the treatment group and during the final follow-up call for both groups. The primary outcome is use of an effective contraceptive six weeks after abortion.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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San Francisco, California, 미국, 94110
- San Francisco General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Women over the age of 15 who choose pill, patch or ring to begin after their abortion
- Women able and willing to be contacted by phone for up to 2 months after enrollment
Exclusion Criteria:
- Women who do not speak and read English or Spanish
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: Control
The control group will not receive a counseling phone call one month after enrollment.
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실험적: Intervention
Intervention arm receives a counseling phone call 3 to 4 weeks after enrollment.
The call is from a health educator intended to assist with contraception.
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Subjects in the treatment arm will receive a phone call from a health educator to assist with contraception, 3 to 4 weeks after enrollment.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants Using an Effective Contraceptive Method 6 Weeks After Abortion
기간: 6 weeks after abortion procedure
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To determine use of an effective contraceptive method six weeks after abortion in women who choose combined hormonal contraception (CHC) and who receive a three-week educational phone call as compared to women who do not receive the intervention.
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6 weeks after abortion procedure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Reasons for Discontinuation of Contraception
기간: 6 weeks after abortion procedure
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To describe the most common concerns and logistical problems women experience with initiating and adhering to CHC after abortion. To describe the concerns that lead to discontinuation or method change. To assess feasibility of conducting a follow-up telephone call in this population |
6 weeks after abortion procedure
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jody Steinauer, MD, MAS, University of California, San Francisco
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
키워드
기타 연구 ID 번호
- RCT 10-01978
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