Period Pills for Menstrual Regulation: A New Reproductive Health Option (Period Pills)
연구 개요
상세 설명
Period pills (a combination of mifepristone and misoprostol) for people who suspect, but have not confirmed pregnancy, has the potential to fulfill this growing need. In the United States (U.S.), a handful of providers currently offer period pills alongside other contraceptive and abortion services in their practice (https://www.periodpills.org/providers). This proposed study would aim to assess the acceptability of this growing service as a fertility regulation method to be utilized before a person confirms they are pregnant.
Dr. Ushma Upadhyay (Professor) and Dr. Tania Serna (Associate Clinical Professor) at UCSF's Department of Obstetrics, Gynecology & Reproductive Science are proposing the Period Pills Study to test a traditional but underutilized framework of menstrual regulation for pregnancy loss, to "bring back" a period when it is late, or missed. This study will aim to recruit 100 participants who have a late period to address research questions that focus on the feasibility and acceptability of using period pills for menstrual regulation.
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Jennifer Ko, MLIS
- 전화번호: 415-353-9113
- 이메일: jennifer.ko@ucsf.edu
연구 연락처 백업
- 이름: Ushma D Upadhyay, PhD, MPH
- 전화번호: 415-353-4626
- 이메일: ushma.upadhyay@ucsf.edu
연구 장소
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California
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Oakland, California, 미국, 94612
- 모집하지 않고 적극적으로
- UCSF Advancing New Standards in Reproductive Health (ANSIRH)
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Virginia
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Roanoke, Virginia, 미국, 24017
- 모병
- Roanoke Health Center
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연락하다:
- Christine Hernández, MPH, MPM, CPHQ
- 전화번호: 828-280-5723
- 이메일: christina.hernandez@ppsat.org
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연락하다:
- Matthew Zerden, MD, MPH
- 전화번호: 617-935-2394
- 이메일: matthew.zerden@ppsat.org
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Be 18 years old or older
- Read and speak English
- Know the date of their last menstrual period within 2 days
- Have a period that is late by up to 21 days
- Must have had regular periods in the last 4 months
- Does not want to be pregnant
- Does not want to verify pregnancy status
- Understand that if they are pregnant, the pills will end their pregnancy
- Does not have contraindications to mifepristone and misoprostol (Risk factors for ectopic pregnancy; history of bleeding disorder or anticoagulant therapy; history of chronic adrenal failure, long-term corticosteroid therapy; allergy to mifepristone/misoprostol/prostaglandins; history of hemorrhagic disorders or anticoagulant therapy; history of inherited porphyrias; has an IUD; currently use a contraceptive implant or injectable)
Exclusion Criteria:
- Under 18 years old
- Does not read and speak English
- Does not know the date of their last menstrual period within 2 days
- Has not had regular periods in the last 4 months
- Wants to be pregnant
- Wants to verify pregnancy status
- Does not display understanding that if they are pregnant, the pills will end their pregnancy
- Has any contraindications to mifepristone and misoprostol (Risk factors for ectopic pregnancy; history of bleeding disorder or anticoagulant therapy; history of chronic adrenal failure, long-term corticosteroid therapy; allergy to mifepristone/misoprostol/prostaglandins; history of hemorrhagic disorders or anticoagulant therapy; history of inherited porphyrias; has an IUD; currently use a contraceptive implant or injectable)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Study Participants
Study participants will be persons who have late period of up to 21 days
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Study participants are given mifepristone and misoprostol for menstrual regulation.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Interest in period pills
기간: Documented at Enrollment Survey
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The proportion of the clinic-going population that may be interested in a period pill to bring on a late period and accept not having their pregnancy confirmed beforehand, therefore not knowing whether they terminated a pregnancy.
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Documented at Enrollment Survey
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Satisfaction with period pills
기간: Documented at Follow-up Survey, 4 weeks after drug administration
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The proportion of participants reporting being "satisfied" or "very satisfied" with the period pills on a five-point Likert scale at follow-up (4 weeks).
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Documented at Follow-up Survey, 4 weeks after drug administration
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Efficacy of period pills
기간: Documented at the follow-up visit, through study completion at around 4 weeks after drug administration.
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The proportion of participants that successfully brought down their period, resulting in a negative pregnancy test and the return of their period.
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Documented at the follow-up visit, through study completion at around 4 weeks after drug administration.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ushma D Upadhyay, PhD, MPH, University of California, San Francisco
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 25-45282
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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