Foley Catheter vs. Foley + Extra-amniotic Saline Infusion for Labor Induction at 41 Weeks and Beyond (FEASI)
The Effect of Foley Catheter Versus Foley Plus Extra-amniotic Saline Infusion on Bishop Progression, Labor Parameters, and Perinatal Outcomes in Pregnancies at 41 Weeks and Beyond: A Randomized Controlled Trial"
This study is a prospective, randomized controlled trial conducted at Ankara Bilkent City Hospital to compare two mechanical methods for labor induction in post-term pregnancies. The research evaluates the efficacy and safety of a Foley catheter alone versus a Foley catheter combined with extra-amniotic saline infusion (EASI). The study specifically targets primiparous women with a gestational age greater than or equal to 41+0 weeks and an unfavorable cervix, defined as an initial Bishop score less than or equal to 6. The primary objective is to determine the change in the Bishop score within the first 6 hours to identify which method more effectively promotes cervical ripening and successful labor induction.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Background and Rationale: Labor induction is the artificial initiation of contractions before spontaneous labor to achieve vaginal delivery. Mechanical methods, such as the Foley catheter, induce cervical ripening by creating physical pressure and stimulating the local release of prostaglandins. This study aims to provide evidence-based data on whether the addition of a continuous saline infusion (EASI) to the Foley catheter results in shorter labor durations and higher vaginal delivery rates compared to the catheter alone.
Study Design and Population:
- Design: A prospective, 1:1 randomized controlled clinical trial.
- Setting: All procedures are conducted under standardized aseptic conditions by trained operators in the delivery unit of Ankara Bilkent City Hospital.
- Sample Size: Based on a power analysis with an effect size of $d = 0.80$, a total of 60 to 64 participants (30 to 32 per group) will be enrolled to account for potential data loss.
Inclusion and Exclusion Criteria:
- Inclusion: Primiparous women , gestational age greater than or equal to 41+0 weeks , singleton pregnancy in cephalic presentation , reactive non-stress test (NST) with a biophysical profile greater than or equal to 8/10 , and a Bishop score less than or equal to 6.
- Exclusion: Multiple pregnancies , ruptured membranes , previous uterine surgery (e.g., Cesarean section) , placenta previa , fetal growth restriction (IUGR) , or high-risk systemic diseases such as severe heart disease or diabetes.
Study Procedures and Monitoring: Participants are randomly assigned to either the Foley group or the Foley+EASI group. Labor progress is monitored according to standard obstetric protocols. The study monitors several parameters, including the time from induction to active labor, total delivery time, and the mode of delivery.
Outcome Measures:
- Primary Outcome: Change in the Bishop score recorded 6 hours after induction.
- Secondary Outcomes: Vaginal delivery rate within 24 hours , Cesarean section rates and indications , maternal infection indicators such as fever greater than or equal to 38°C or chorioamnionitis , and neonatal outcomes including Apgar scores and birth weight.
Statistical Analysis: Data will be analyzed using descriptive statistics. Continuous variables will be compared using the Student's t-test or Mann-Whitney U test , while categorical variables will be evaluated using the Chi-square or Fisher's exact test. A p-value less than 0.05 will be considered statistically significant.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：AYŞENUR TÜRE, M.D
- 電話番号：+905377871445
- メール：draysenuryeniceri@gmail.com
研究場所
-
-
ÇANKAYA
-
Ankara、ÇANKAYA、トルコ（Türkiye）
- 募集
- Bilkent City Hospital
-
コンタクト：
- AYŞENUR TÜRE
- 電話番号：05377871445
- メール：draysenuryeniceri@gmail.com
-
-
参加基準
適格基準
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:
Primiparous women (First-time mothers).
Gestational age greater than or equal to 41+0 weeks.
Singleton pregnancy in cephalic presentation.
Unfavorable cervix, defined as a Bishop score less than or equal to 6.
Reactive Non-Stress Test (NST) and a biophysical profile score greater than or equal to 8/10.
Aged greater than or equal to 18 years.
Willingness to provide written informed consent. -
Exclusion Criteria:
Multiple pregnancies (e.g., twins, triplets).
Previous uterine surgery (e.g., prior Cesarean section or myomectomy).
Premature Rupture of Membranes (PROM).
Presence of placenta previa or vasa previa.
Fetal growth restriction (IUGR).
Active genital herpes infection.
Known hypersensitivity to the materials used (e.g., latex allergy if applicable).
Serious maternal systemic diseases (e.g., severe heart disease, uncontrolled diabetes, or preeclampsia).
Fetal anomalies or non-reassuring fetal heart rate patterns.
-
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）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Foley Catheter + EASI
"Participants in this arm will receive a single-balloon Foley catheter (16-18 French) inserted into the extra-amniotic space through the internal os of the cervix. The balloon will be inflated with 30-50 ml of sterile saline. Additionally, a continuous extra-amniotic saline infusion (EASI) will be administered at a rate of 30 ml/hour to enhance cervical ripening." |
A single-balloon Foley catheter (16-18 French) is inserted through the internal os of the cervix into the extra-amniotic space under aseptic conditions. The balloon is inflated with 30-50 ml of sterile saline. Following placement, a continuous extra-amniotic saline infusion (EASI) is administered through the catheter at a constant rate of 30 ml per hour using an infusion pump. The procedure aims to induce cervical ripening through both mechanical pressure and biochemical stimulation.
他の名前：
|
|
アクティブコンパレータ：Foley Catheter Alone
Participants in this arm will receive a single-balloon Foley catheter (16-18 French) inserted into the extra-amniotic space through the internal os of the cervix. The balloon will be inflated with 30-50 ml of sterile saline. No additional saline infusion will be administered. This group serves as the standard mechanical induction control." |
A single-balloon Foley catheter (16-18 French) is inserted through the internal os of the cervix into the extra-amniotic space under aseptic conditions. The balloon is inflated with 30-50 ml of sterile saline. The catheter is then taped to the inner thigh of the patient to maintain tension. No saline infusion is administered in this group. The catheter remains in place until spontaneous expulsion or for a maximum duration of 12 hours.
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
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Bishop Score (ΔBishop)
時間枠：From baseline (0 hour) to 6 hours after catheter insertion
|
The Bishop score is a pre-labor scoring system to assist in predicting whether induction of labor will be required. The score (ranging from 0 to 13) evaluates cervical dilation, effacement, consistency, position, and fetal station. This measure represents the numerical increase in the score after 6 hours of induction. |
From baseline (0 hour) to 6 hours after catheter insertion
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rate of Vaginal Delivery within 24 Hours
時間枠：Within 24 hours of induction initiation
|
The percentage of participants who achieved a successful vaginal delivery within the first 24 hours |
Within 24 hours of induction initiation
|
|
Total Induction to Delivery Duration
時間枠：From the start of catheter insertion until the birth of the neonate (typically up to 48 hours).
|
The total time elapsed (in hours) from the beginning of the induction procedure to the actual delivery |
From the start of catheter insertion until the birth of the neonate (typically up to 48 hours).
|
|
Neonatal Apgar Scores
時間枠：At 1 minute and 5 minutes after birth.
|
Evaluation of the newborn's physical condition using the Apgar scoring system (0-10 scale). |
At 1 minute and 5 minutes after birth.
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Karjane NW, Brock EL, Walsh SW. Induction of labor using a foley balloon, with and without extra-amniotic saline infusion. Obstet Gynecol. 2006 Feb;107(2 Pt 1):234-9. doi: 10.1097/01.AOG.0000198629.44186.c8.
- Abramovici D, Goldwasser S, Mabie BC, Mercer BM, Goldwasser R, Sibai BM. A randomized comparison of oral misoprostol versus Foley catheter and oxytocin for induction of labor at term. Am J Obstet Gynecol. 1999 Nov;181(5 Pt 1):1108-12. doi: 10.1016/s0002-9378(99)70090-6.
- Vaknin Z, Kurzweil Y, Sherman D. Foley catheter balloon vs locally applied prostaglandins for cervical ripening and labor induction: a systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Nov;203(5):418-29. doi: 10.1016/j.ajog.2010.04.038.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- TABED 2-25-1766
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
There is no plan to share individual participant data. The study results will be published in aggregate form in a peer-reviewed journal
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。