University of North Carolina-Healthwise Partnership Project on Birth Options Decision Aid (B-READY)
Pilot Study to Assess the Effectiveness of a Decision Tool for Cesarean Delivery vs. Trial of Labor
This is pilot quasi-experimental study of women with one or two prior cesarean deliveries who are now pregnant and eligible for a trial of labor after cesarean delivery, to assess whether a decision aid, providing knowledge about trial of labor (VBAC) and planned repeat cesarean delivery can improve the birth options decision-making process for patients.
Participants are screened for eligibility through electronic health records. Once an individual is screened eligible, and email invite is sent providing information about the study and assessing the interest in participation. An on-line consent is completed and women are entered sequentially into the usual care group and then through further recruitment, another sample of women are entered into the decision aid group. The primary outcome is satisfaction with the shared decision-making process with their provider.
調査の概要
詳細な説明
Once a potential participant is screened eligible, completes the on-line informed consent, they are officially enrolled in the study and sent a link confirming their enrollment and the study group in which they have been assigned. Participants are sequentially enrolled in the study with enrollment first into the usual care group. Once enrollment in the usual care group is complete, enrollment into the decision aid group will occur.
The study includes two non-randomized groups:
Arm 1 (Usual care group): Women in this group will undergo usual care and complete the survey questions on knowledge of risks and benefits of TOLAC (also referred to as VBAC) and planned repeat cesarean (PRCS), certainty of their decision, and involvement in the decision for trial of labor (TOLAC) or repeat cesarean delivery.
Arm 2: (Decision aid group- group receiving the decision tool): Women in this group will receive a decision aid prior to undergoing counseling by their physician. Following completion of the decision aid and physician counseling, they will complete a series of survey questions to assess their knowledge of the risks and benefits of TOLAC and PRCS, certainty of their decision, and involvement in the decision for repeat cesarean or TOLAC.
The decision aid group will be compared with women who do not receive the decision aid (usual care group).
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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North Carolina
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Chapel Hill、North Carolina、アメリカ、27517
- University of North Carolina - Chapel Hill
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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:
- Gestational age between 19/0 and 36/6 weeks
- History of 1 or 2 prior cesarean deliveries
Exclusion Criteria:
- No contraindications to trial of labor after cesarean (TOLAC)
- No history of prior TOLAC
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：非ランダム化
- 介入モデル：順次割り当て
- 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 |
|---|---|
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介入なし：Usual care
Women in this group will undergo usual care and the complete the survey questions on knowledge and involvement in the decision for trial of labor after cesarean (TOLAC) or repeat cesarean.
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アクティブコンパレータ：Decision Aid
Women in this group will receive a decision aid prior to undergoing counseling by their physician.
Following completion of the decision aid and physician counseling, they will complete a series of survey questions to assess their perceptions of their knowledge and involvement in the decision for trial of labor after cesarean (TOLAC) or repeat cesarean delivery.
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The decision aid is a series of web pages that includes videos, questions, and evidence-based information.
The decision aid is designed to help women think about what matters to them and what questions they may have for their doctor or midwife.
At the end, they receive a summary of which way they are leaning and what matters most to them.
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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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Shared Decision Making (SDM) Process score
時間枠：Up to 6 months prior to delivery
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This is a measure of the patient's involvement in the decision.
1 point is assigned for discussing the pros 'a lot' or 'some'; 1 point is assigned for discussing the cons 'a lot' or 'some'; 1 point is assigned for responding 'yes' if the provider explained the options; and 1 point is assigned for responding 'yes' that the provider asked the patient what treatment she wanted.
The tool's score range is 0-4.
A higher score indicates more involvement in the decision.
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Up to 6 months prior to delivery
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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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Number of Participants (by category) With the Intent to Deliver by Repeat Cesarean Section or by Vaginal Delivery
時間枠：Date of Admission
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Intended mode of delivery (repeat cesarean or vaginal) prior to actual delivery
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Date of Admission
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Number of Participants (by category) who Delivered by Repeat Cesarean or Vaginal Delivery
時間枠：Up to 72 hours after delivery
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Actual method of delivery (repeat cesarean or vaginal delivery)
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Up to 72 hours after delivery
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Maternal or Fetal Complications at Delivery
時間枠：Up to 72 hours after delivery
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Number of complication events: maternal postpartum hemorrhage, infection, fetal admission to neonatal intensive care unit.
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Up to 72 hours after delivery
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Number of Participants (by Category) who desired Repeat Cesarean, Vaginal Delivery or Are Undecided after completion of the study survey
時間枠：Up to 6 months prior to delivery
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Participant responses are: 1) repeat cesarean delivery, 2) vaginal delivery and 3) undecided
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Up to 6 months prior to delivery
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協力者と研究者
協力者
捜査官
- 主任研究者：Wanda K Nicholson, MD、Univerisity of North Carolina - Chapel Hill
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 (実際)
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 (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
その他の研究ID番号
- 17-2023
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
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
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。