Melatonin to improve induction of labour: a double blind, randomised, placebo controlled trial.

Phase 3

• Conditions: Failed Induction of Labour; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12616000311459
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-09
• Study Completion: 2021-08-14
• Last Update Posted: 31 January 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 187

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified