Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy
Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy: A Randomized Controlled Trial
調査の概要
詳細な説明
Induction of labour is commonly performed when continuation of pregnancy is considered less beneficial than delivery. This randomized controlled trial will compare the effectiveness and safety of two approaches to cervical ripening and induction of labour in women with term pregnancy.
Eligible participants will have a gestational age of 37-42 weeks and will be admitted to the hospital for induction of labour without significant comorbidities. Gestational age will be confirmed using a dating scan or last menstrual period, and baseline fetal monitoring will be performed using cardiotocography (CTG) before induction.
Participants will be randomly allocated to one of two treatment groups.
In the concurrent group, a PGE2 vaginal pessary and a Foley catheter will be inserted concurrently. The Foley catheter balloon will be inflated with 30 mL of normal saline.
In the sequential group, the Foley catheter will be inserted first, followed by insertion of the PGE2 vaginal pessary 12 hours later.
The study will primarily assess the rate of vaginal delivery within 24 hours of initiation of induction. The study will also assess the overall effectiveness and safety of the two induction approaches, including the induction-to-delivery interval and relevant maternal and fetal complications.
Potential complications associated with induction of labour include failure of induction, uterine hyperstimulation, fetal distress or abnormal CTG, meconium-stained liquor, postpartum haemorrhage, uterine rupture, and chorioamnionitis. Participants will be continuously monitored during the induction process so that appropriate clinical management can be provided if complications occur.
The findings of this study may contribute to the development of safe, effective, and patient-centred induction-of-labour protocols, particularly in resource-constrained healthcare settings.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Shahzadi Saima Hussain, MHR
- 電話番号:+923337111981
- メール:saima.hussain@lrh.edu.pk
研究連絡先のバックアップ
- 名前:Dr Jawad Khan, PhD
- 電話番号:+92 334 9011681
- メール:mdrjawad@yahoo.com
研究場所
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KPK
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Peshawar、KPK、パキスタン、25000
- Lady Reading Hospital
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コンタクト:
- Dr Jawad Khan, PhD
- 電話番号:+92 334 9011681
- メール:mdrjawad@yahoo.com
-
コンタクト:
- Shezadi Saima Hussain, MHR
- 電話番号:+92 333 7111981
- メール:saima.hussain@lrh.edu.pk
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Pregnant women aged 18-40 years with a singleton cephalic fetus between 37 and 42 weeks of gestation who require induction of labour, with BMI 20-35 kg/m², intact membranes, and reassuring cardiotocography (CTG), will be included.
Exclusion Criteria:
- Women with meconium-stained liquor, antepartum haemorrhage, low-lying placenta defined as placental edge less than 2 cm from the internal os on ultrasonography, pre-eclampsia, fetal growth restriction, previously scarred uterus, estimated fetal weight greater than 4 kg on ultrasound, cephalopelvic disproportion, or liquor abnormalities will be excluded.
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 |
|---|---|
|
実験的:Concurrent Induction of Labour
Participants will receive concurrent cervical ripening with a PGE2 vaginal pessary and insertion of a Foley catheter.
The Foley catheter balloon will be inflated with 30 mL of normal saline.
Both interventions will be initiated concurrently at the start of induction of labour.
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A Foley catheter will be used for mechanical cervical ripening.
The balloon will be inflated with 30 mL of normal saline.
A PGE2 vaginal pessary will be used as a pharmacological method of cervical ripening during induction of labour.
|
|
アクティブコンパレータ:Sequential Induction of Labour
Participants will receive sequential cervical ripening with a Foley catheter followed by insertion of a PGE2 vaginal pessary 12 hours later.
The Foley catheter will be inserted first, followed by the PGE2 vaginal pessary after 12 hours.
|
A Foley catheter will be used for mechanical cervical ripening.
The balloon will be inflated with 30 mL of normal saline.
A PGE2 vaginal pessary will be used as a pharmacological method of cervical ripening during induction of labour.
|
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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Time from initiation of induction of labour to vaginal delivery
時間枠:From initiation of induction of labour until vaginal delivery, up to 24 hours
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Time interval from the initiation of cervical ripening intervention to vaginal delivery, measured in hours.
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From initiation of induction of labour until vaginal delivery, up to 24 hours
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Successful vaginal delivery
時間枠:From initiation of induction of labour until delivery, up to 24 hours
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Proportion of participants who achieve vaginal delivery following induction of labour.
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From initiation of induction of labour until delivery, up to 24 hours
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協力者と研究者
捜査官
- 主任研究者:Shahzadi Saima Hussain, MHR、Khyber Medical University Peshawar, Pakistan
- スタディディレクター:Dr Jawad Khan, PhD、Khyber Medical University Peshawar, Pakistan
- 主任研究者:Dr Mehnaz Faisal, MHPE, FCPS、Lady Reading Hospital Peshawar
出版物と役立つリンク
一般刊行物
- Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
- Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.
- de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2019 Oct 18;10(10):CD001233. doi: 10.1002/14651858.CD001233.pub3.
- Eser A, Ozkaya E, Abide CY, Eser T, Eser GY, Abike F, Tayyar AT, Eroglu M. Transcervical Foley balloon catheter and vaginal prostaglandin E2 insert combination vs. vaginal prostaglandin E2 insert only for induction of labor at term: a randomized clinical trial. Arch Gynecol Obstet. 2019 Feb;299(2):451-457. doi: 10.1007/s00404-018-4998-8. Epub 2018 Dec 7.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
キーワード
その他の研究ID番号
- KMU/DIR/CTU/2026/12
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
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
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