The Acceptability and Feasibility of an Alternative to Routine Follow-up Visit After Medical Abortion in Vietnam
The Acceptability and Feasibility of an Alternative to a Routine Follow-up Visit After Medical Abortion in Vietnam
This trial will compare the efficacy and acceptability of post-medical abortion follow-up by assigning women to either 1) alternative follow-up via routine semi-quantitative pregnancy test and a self-administered follow-up questionnaire, or 2) the standard of care: a routine follow-up visit including a bimanual exam and vaginal ultrasound.
The goal of the study is to provide answers to the following questions:
- Is a follow-up protocol that employs a self-administered questionnaire and at home use of a semi-quantitative pregnancy test effective at identifying women with ongoing pregnancies?
- Is an innovative follow-up protocol more acceptable to women and providers than the current standard of care?
- Is an innovative follow-up protocol feasible to implement in abortion services in Vietnam?
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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Hanoi、ベトナム
- National Ob-Gyn Hospital
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Hanoi、ベトナム
- Hanoi Ob-Gyn Hospital
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Ho Chi Minh City、ベトナム
- HocMon District Hospital
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Ho Chi Minh City、ベトナム
- Hung Vuong Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Reproductive age women seeking medical abortion services
- Intrauterine pregnancy less than or equal to 63 days gestation on the day of mifepristone administration
- Hold a working, personal phone number
- be willing and able to sign consent forms and agree to comply with study procedures
Exclusion Criteria:
- Pregnancy greater than 63 days gestation on the day of mifepristone administration
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
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介入なし：Standard of care for post medical abortion follow-up
Standard of care includes a routine hospital visit two weeks after mifepristone administration.
At the hospital visit, the woman will undergo a bimanual and vaginal ultrasound examination.
In the event the woman fails to return for the follow-up visit, each hospital will follow their standard procedure for contacting women who fail to attend their follow-up visit, i.e. three efforts to contact the woman.
Form 2a will document the results of any clinical examinations, any additional medical abortion-related care given and the abortion outcome.
At the follow-up visit, women will also be asked about the acceptability of current medical abortion follow-up procedures and their future preferences.
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アクティブコンパレータ：Alternative follow-up
At their first clinic visit, women will be asked to provide their phone number for contact purposes. Women will also be asked to complete a semi-quantitative pregnancy test in the clinic and the results of the test will be noted on a study form. After mifepristone administration, women will be provided with a second semi-quantitative pregnancy test and a self-administered checklist. Women will be instructed to complete the checklist and perform the pregnancy test at home on an assigned date two weeks after mifepristone administration. The checklist will indicate that if the woman answers "yes" to any of the questions, then she should return to the clinic for a follow-up visit. On the assigned date, women will also be contacted by phone by the clinic staff. Women will be asked to confirm whether they completed the pregnancy test and checklist and asked to report on the results of both tests. |
After mifepristone administration, women will be provided with a second semi-quantitative pregnancy test and a self-administered checklist.
Women will be instructed to complete the checklist and perform the pregnancy test at home on an assigned data two weeks after mifepristone administration.
On the assigned date, women will also be contacted by phone by the clinic staff.
Women will be asked to confirm whether they completed the pregnancy test and checklist and asked to report on the results of both tests.
Provider will review the women's responses to the checklist and confirm whether, based on the woman's responses, she should return for a follow up visit.
During the follow-up phone call, women will also be asked about the satisfaction and acceptability of the alternative follow-up procedure.
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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 |
時間枠 |
|---|---|
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Continued, ongoing pregnancy
時間枠：9 months
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9 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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percentage of women who return for follow-up
時間枠：9 months
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9 months
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percentage of women receiving other treatment for ongoing pregnancy
時間枠：9 months
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9 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Nguyen Thi Nhu Ngoc, MD, MSc、Center for Research and Consultancy in Reproductive Health
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
その他の研究ID番号
- 6.4
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