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Balloon catheter plus concurrent vaginal misoprostol versus vaginal misoprostol alone for cervical ripening in induction of labour: An individual participant data meta-analysis of randomised controlled trials.
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  • Malitha PATABENDIGE,
  • Fei Chan,
  • Zainab Al-Ibraheemi,
  • Davies K. Kibii,
  • Alfred O. Osoti,
  • Philip Ayieko,
  • Tarakeswari Surapaneni,
  • Marino Romero Ramirez,
  • Angeles Vives Argilagos,
  • Sidra Gilani,
  • Syeda Mazhar,
  • Daniel Rolnik,
  • Ben Mol,
  • Wentao Li
Malitha PATABENDIGE
Monash University Department of Obstetrics and Gynaecology

Corresponding Author:[email protected]

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Fei Chan
Monash University Department of Obstetrics and Gynaecology
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Zainab Al-Ibraheemi
Mount Sinai West Hospital
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Davies K. Kibii
University of Nairobi
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Alfred O. Osoti
University of Nairobi
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Philip Ayieko
London School of Hygiene & Tropical Medicine Department of Infectious Disease Epidemiology
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Tarakeswari Surapaneni
Fernandez Hospital
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Marino Romero Ramirez
Consorci Sanitari de Terrassa
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Angeles Vives Argilagos
Consorci Sanitari de Terrassa
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Sidra Gilani
MCH center
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Syeda Mazhar
MCH center
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Daniel Rolnik
Monash University Department of Obstetrics and Gynaecology
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Ben Mol
Monash University Department of Obstetrics and Gynaecology
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Wentao Li
Monash University Department of Obstetrics and Gynaecology
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Abstract

Background: Cervical ripening in labour induction using a combination of methods is gaining popularity, but the effectiveness and safety of this approach are not clear. Objective: To compare the effectiveness, perinatal and maternal safety of cervical ripening in the induction of labour (IOL) using a balloon catheter with concurrent low-dose vaginal misoprostol (combined group) versus low-dose vaginal misoprostol alone. Search Strategy: MEDLINE, Embase, Emcare, Scopus, Cochrane Library, WHO ICTRP and clinicaltrials.gov. Selection Criteria: Randomised controlled trials (RCTs), viable singleton gestation, no language restrictions, published and unpublished data. Data Collection and Analysis: Systematic search, screening for trustworthiness and study quality, and an individual participant data (IPD) meta-analysis were conducted. Main Results: Eight of 22 RCTs provided IPD, of which three were excluded due to trustworthiness concerns after IPD checking (604 women). Thirteen of 22 RCTs (59.1%) were identified as ‘ not meeting trustworthiness criteria’. This IPD meta-analysis included five RCTs (649 women): two had prospective, another two had retrospective trial registrations, and one RCT was unregistered. Vaginal delivery rate, composite adverse perinatal and maternal outcomes were comparable between the two groups in the IPD meta-analysis. Vaginal delivery rate, based on aggregate data from eight RCTs ‘meeting trustworthiness criteria’ (IPD and non-IPD), had an Odds Ratio (OR) of 1.07 (95% CI 0.68;1.68). In comparison, data from thirteen RCTs ‘not meeting trustworthiness criteria’ (IPD and non-IPD) showed an OR of 1.25 (95% CI 0.88;1.77). Conclusions: Based on trustworthy data, the effectiveness of the combined group and the low-dose vaginal misoprostol group is likely to be comparable. We are uncertain about the safety of using a balloon catheter with concurrent low-dose vaginal misoprostol due to low data retrieval and trustworthiness concerns among the underlying RCTs.
25 Nov 2024Submitted to BJOG: An International Journal of Obstetrics and Gynaecology
29 Nov 2024Submission Checks Completed
29 Nov 2024Assigned to Editor
29 Nov 2024Review(s) Completed, Editorial Evaluation Pending
10 Dec 2024Reviewer(s) Assigned