Foley Labor Induction Trial at Term and in PROM
A Randomized Trial of Foley Bulb Induction With and Without Simultaneous Use of Oxytocin
This study is considering current standard oxytocin dosing regimen in combination with Foley bulb for cervical ripening is associated with improved outcomes including greater percentage of women delivered within or less than 24 hours. The investigators will also assess other maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis), bleeding, uterine atony, cesarean delivery and use of regional analgesia.
Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or no oxytocin while the Foley bulb is in place. As part of standard of care for inductions, Foley bulbs will be placed for all participants. Study participants who are randomly assigned to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed. Study participants randomly assigned to no oxytocin will receive the oxytocin once the Foley bulb is removed.
After delivery, information will be collected from participant's chart on the outcome of pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean section), and baby's outcome (such as birth weight, APGAR scores, and any complications).
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
New York
-
Elmhurst、New York、アメリカ、11373
- Elmhurst Hospital Center
-
New York、New York、アメリカ、10029
- Icahn School of Medicine at Mount Sinai
-
-
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:
- women at > 24 weeks gestation
- a non-anomalous, singleton fetus in a vertex presentation
Exclusion Criteria:
- history of prior uterine surgery such as cesarean section or myomectomy
- unexplained vaginal bleeding
- latex allergy
- contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active vaginal bleeding, macrosomia etc)
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：処理
- 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 |
|---|---|
|
介入なし：Control
No oxytocin while the Foley bulb is in place
|
|
|
実験的：Oxytocin
Use of oxytocin while the Foley bulb is in place
|
Use of oxytocin while the Foley bulb is in place
他の名前：
|
|
実験的：PROMS Foley and oxytocin
Subjects who are induced due to premature rupture of membranes randomized to use of Foley bulb and oxytocin once the bulb is removed.
|
Use of oxytocin while the Foley bulb is in place
他の名前：
|
|
介入なし：PROMS no Foley bulb
Subjects who are induced due to premature rupture of membranes randomized to no Foley bulb.
|
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 |
|---|---|---|
|
induction time to delivery
時間枠：Time from induction to delivery, average 12-28 hours
|
The time from induction to delivery will be starting from the time the first induction agent is used on the patient until the official time of birth of the neonate.
|
Time from induction to delivery, average 12-28 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mode of delivery
時間枠：average of 12-28 hours from induction until official time of birth
|
The mode of delivery is ascertained from the delivery summary as either spontaneous vaginal delivery, cesarean delivery, vacuum assisted vaginal delivery, or forcep assisted vaginal delivery.
|
average of 12-28 hours from induction until official time of birth
|
|
estimated blood loss
時間枠：average of 12-28 hours from induction until official time of birth
|
average of 12-28 hours from induction until official time of birth
|
|
|
uterine atony
時間枠：average of 12-28 hours from induction until official time of birth
|
uterine atony is assessed by both provider report and/or the use of uterotonics as indicated by the chart.
|
average of 12-28 hours from induction until official time of birth
|
|
chorioamnionitis
時間枠：average of 12-28 hours from induction until official time of birth
|
Chorioamnionitis is ascertained from provider report as fever with either maternal/fetal tachycardia, fundal tenderness, or foul smelling fluid while the patient is in labor.
|
average of 12-28 hours from induction until official time of birth
|
|
neonatal birthweight
時間枠：average of 12-28 hours from induction until official time of birth
|
average of 12-28 hours from induction until official time of birth
|
協力者と研究者
捜査官
- 主任研究者：Angela Bianco, MD、Icahn School of Medicine at Mount Sinai
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 (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
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。