Trial of Immediate Versus Delayed Initiation of Oral Contraceptive Pills After Abortion
Immediate Versus Delayed Initiation of Oral Contraceptive Pills After Therapeutic Abortion - A Randomized Trial
調査の概要
詳細な説明
The United States has a higher rate of unintended pregnancy than Canada or any other developed nation in Europe. OCPs are the most common method of hormonal contraception used in this country. Perfect use can lead to failure rates as low as 0.1% per year. Actual failure rates are much higher, often due to non-compliance with OCP use. Several recent studies have examined the "Quick Start", or initiation of OCPs in front of the provider while still at the clinic, regardless of time in the cycle. These studies have shown that women who swallowed the first OCP in the clinic were more likely to continue the OCP into the second month. Women who are seen in clinics for a therapeutic abortion (TAB) are often at extremely high risk for another unintended/unwanted pregnancy. If compliance in OCP use could be improved in this group of women, unintended/unwanted pregnancy rates could be reduced. One concern about the "Quick Start" technique is that women may have already ovulated or conceived when OCPs are initiated mid-cycle. In the post-abortal setting, this is not a concern. Applying the "Quick Start" technique to post-abortion patients and having women take the first of their OCPs while still in the clinic after their abortion may improve compliance and continuation of OCP use.
This is a prospective, randomized, controlled trial in post-abortal women, and will last approximately 24 months. All of the study subjects will receive a single pack of combination OCPs and a one-year prescription after their TAB. The women in the immediate start arm will then take their first OCP in the clinic, observed by clinic staff, before leaving. The controls will be instructed to begin the OCPs on the first Sunday following their abortion. All subjects will receive the same medication with the only difference being the timing of initiation of the OCPs. Measurements of continuation will be determined by telephone interviews administered at two and six months after the subjects' abortion.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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California
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San Francisco、California、アメリカ、94110
- Women's Options Clinic at San Francisco General 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:
- Any woman aged 13-45 who presents to the Women's Options Clinic and desires to use OCPs for post-abortion contraception.
Exclusion Criteria:
- Gestational age above 23 weeks and 1 day.
- Any absolute contraindication for combination OCP use (smoking > 20 cigarettes a day over age 35, history of venous thromboembolic event or pulmonary embolism, history of or current ischemic heart disease, history of stroke, vascular disease, complicated valvular heart disease [pulmonary hypertension, atrial fibrillation, history of subacute bacterial endocarditis], severe hypertension with blood pressure >160/100, migraines with focal neurologic symptoms, current breast cancer, active viral hepatitis, severe cirrhosis, or benign or malignant liver tumors).
- Patients who speak languages other than English or Spanish.
- Patients who do not have a phone or who have a phone where any contact might compromise the confidentiality of their abortions.
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Immediate start
Initiate selected birth control method before leaving the clinic at the time of the abortion procedure.
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アクティブコンパレータ：Sunday start
Begin birth control the first Sunday after leaving the clinic
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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 |
|---|---|---|
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Continuation of OCPs after abortion
時間枠：Two and six months post-enrollment
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Assessed by phone survey
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Two and six months post-enrollment
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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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Compliance with OCPs after abortion
時間枠：Two and six months post-enrollment
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assessed by phone survey
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Two and six months post-enrollment
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Bleeding patterns on OCPs after abortion
時間枠：Two months post-abortion
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assessed by phone survey
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Two months post-abortion
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Satisfaction with OCPs after abortion
時間枠：six months post-enrollment
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assessed by phone survey
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six months post-enrollment
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協力者と研究者
捜査官
- 主任研究者：Jody E Steinauer, MD, MAS、University of California, San Francisco
- スタディディレクター：Sarah W Prager, MD、University of California, San Francisco
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
中絶の臨床試験
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HaEmek Medical Center, Israelわからない