Misoprostol With Intrauterine Device Insertion
Effect of Prophylactic Misoprostol Prior to Intrauterine Device Insertion
調査の概要
詳細な説明
The investigators intend to conduct a randomized double blind study at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette.
Subjects will be approached only after deciding to get an intrauterine. When the participants return for intrauterine device placement, at 90 minutes prior to the procedure half will receive misoprostol and half will receive placebo. The subjects will be asked to rate their level of pain at specific points during the insertion. Providers will be asked to mark whether or not additional dilation was required as well as their perceived ease of intrauterine device placement.
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
-
-
Oregon
-
Portland、Oregon、アメリカ、97239
- Oregon Health & Science University
-
Portland、Oregon、アメリカ、97206
- Planned Parenthood of the Columbia Willamette
-
-
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:
- Nulliparous women (defined as those without a history of pregnancy, despite the outcome, beyond 20 weeks gestation)
- Ages 18-45
- Seeking long-term reversible contraception with an intrauterine device (either Mirena or Paraguard) through the OHSU Center for Women's Health and Planned Parenthood of the Columbia Willamette
Exclusion Criteria:
- Pregnancy occurring less than 6 weeks from time of presentation
- History of prior intrauterine device placement
- History of Mullerian tract anomalies
- History of uterine surgery
- Allergy or intolerance to misoprostol or other prostaglandin
- Pelvic inflammatory disease (current or within the past 3 months)
- Sexually transmitted diseases (current)
- Puerperal or postabortion sepsis (current or within the past 3 months)
- Purulent cervicitis (current)
- Undiagnosed abnormal vaginal bleeding
- Malignancy of the genital tract
- Known uterine anomalies or fibroids distorting the cavity in a way incompatible with intrauterine device insertion
- Allergy to any component of the intrauterine device or Wilson's disease (for copper- containing intrauterine device)
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:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Misoprostol
Cervical preparation with misoprostol prior to intrauterine device insertion
|
Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.
他の名前:
|
プラセボコンパレーター:Placebo
Cervical preparation with placebo prior to intrauterine device insertion
|
Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.
他の名前:
|
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 |
---|---|---|
The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).
時間枠:Time of IUD insertion
|
Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured.
When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right).
|
Time of IUD insertion
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).
時間枠:At time of IUD insertion
|
Perceived pain measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured.
When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right).
|
At time of IUD insertion
|
協力者と研究者
捜査官
- 主任研究者:Alison Edelman, M.D., M.P.H、Oregon Health and Science University
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
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。