Period Pills for Menstrual Regulation: A New Reproductive Health Option (Period Pills)
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Jennifer Ko, MLIS
- 電話番号：415-353-9113
- メール：jennifer.ko@ucsf.edu
研究連絡先のバックアップ
- 名前：Ushma D Upadhyay, PhD, MPH
- 電話番号：415-353-4626
- メール：ushma.upadhyay@ucsf.edu
研究場所
-
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California
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Oakland、California、アメリカ、94612
- 積極的、募集していない
- UCSF Advancing New Standards in Reproductive Health (ANSIRH)
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Virginia
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Roanoke、Virginia、アメリカ、24017
- 募集
- Roanoke Health Center
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コンタクト：
- Christine Hernández, MPH, MPM, CPHQ
- 電話番号：828-280-5723
- メール：christina.hernandez@ppsat.org
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コンタクト：
- Matthew Zerden, MD, MPH
- 電話番号：617-935-2394
- メール：matthew.zerden@ppsat.org
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Interest in period pills
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Efficacy of period pills
時間枠：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.
|
協力者と研究者
捜査官
- 主任研究者：Ushma D Upadhyay, PhD, MPH、University of California, San Francisco
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 25-45282
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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