A double blind, randomised, placebo controlled trial to evaluate the effect of Melatonin as an adjuvant agent at Induction of labour on the rate of induction of labour failure in healthy, pregnant women undergoing cervical ripening prior to induction of labour for prolonged pregnancy

Monash Health0 个研究点目标入组 187 人开始时间: 2016年3月9日最近更新: 2022年1月31日

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•Pregnant women, parity: 0 (nulliparous) or up to para 3 (multiparous), who currently have a singleton, cephalic presentation undergoing induction of labour for prolonged pregnancy with a low Bishop score (a score of cervical ripeness) of 5 or less.
•Methods of cervical ripening/labour induction to include: cervical balloon catheter e.g. Foley, Cook, Atad and/or a Dinoprostone PGE 2 vaginal pessary e.g. Cervadil or Prostin or women who are only having an amniotomy as the initial method of labour induction.
•Intact membranes. No known significant maternal or obstetric medical condition that would affect melatonin pharmacokinetics or maternal safety. The woman must be able to provide written informed consent to participate in the clinical trial

•Non-reassuring fetal status (e.g. diminished or no fetal movements, non-reassuring CTG, known lethal fetal congenital anomalies or abnormal karyotype, fetal growth restriction (FGR) 10th centile or less, with Doppler changes), a clinical decision indicative of a low threshold for caesarean section, contraindication to a cervical ripening balloon catheter (as per Monash Health CPG IOL Cervical Ripening balloon catheter procedure. Prompt Doc No: SNH0003541 v3.0), known allergy or sensitivity to melatonin or any of the excipients in its formulation, unwillingness or inability to follow the procedures outlined in the PI&CF, mentally, cognitively or legally incapacitated or unable to provide informed consent, co-recruitment/participation in another clinical trial where there is pharmaceutical or herbal or nutritional intervention (such trial interventions would also include: multi-vitamins, minerals, complementary and alternative medicines), currently taking a medication known to influence melatonin pharmacokinetics or bioavailability.

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