Double-blind, randomised, placebo-controlled trial to evaluate the effectiveness of late gestation oral melatonin supplementation in reducing induction of labour rates in nulliparous women: the MyTIME study protocol
Introduction Around the world, rates of induction of labour (IOL) among nulliparous mothers have increased in the last 10 years. In Australia, rates have increased over the last decade by 43%, from 32% to 46%. There is growing concern about the rapid rise in IOL before 41 weeks for nulliparous women...
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BMJ Publishing Group
2025-01-01
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| Online Access: | https://bmjopen.bmj.com/content/15/1/e090370.full |
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| author | Miranda Davies-Tuck Emily Callander Mary Sharp Scott W White Dorota A Doherty Jane Warland Zoe Bradfield Lesley Kuliukas Monique Rose Amber Pettitt Kylie Ekin JA Keelan |
| author_facet | Miranda Davies-Tuck Emily Callander Mary Sharp Scott W White Dorota A Doherty Jane Warland Zoe Bradfield Lesley Kuliukas Monique Rose Amber Pettitt Kylie Ekin JA Keelan |
| author_sort | Miranda Davies-Tuck |
| collection | DOAJ |
| description | Introduction Around the world, rates of induction of labour (IOL) among nulliparous mothers have increased in the last 10 years. In Australia, rates have increased over the last decade by 43%, from 32% to 46%. There is growing concern about the rapid rise in IOL before 41 weeks for nulliparous women without medical complications because of the associated increased rates of caesarean section, reduced satisfaction with birth, and birth trauma. Melatonin potentiates the action of oxytocin and may promote the spontaneous onset of labour; therefore, we will test the hypothesis that exogenous melatonin supplementation in late pregnancy will reduce the rate of labour induction by 30% or more.Methods and analyses This is a double-blind, randomised, placebo-controlled trial in nulliparous pregnant women to reduce IOL rates. We will randomise 530 women to receive either 3 mg oral melatonin or placebo daily from 39+0 weeks’ gestation until they give birth. The primary endpoint will be IOL rate after 39 weeks post enrolment. Secondary endpoints will include the following: interval between administration of trial medication and birth; a range of maternal and neonatal outcomes, including birth outcomes; breastfeeding on discharge, at 10 days and at 2 months; maternal satisfaction; child developmental outcomes at 2 months of age; and cost-effectiveness of melatonin compared with standard care. All data will be analysed by intention to treat.Ethics and dissemination The study is approved by the Western Australia Health Central Human Research Ethics Committee (RGS0000006283). Trial findings will be disseminated through conference presentations and peer-reviewed publications.Trial registration number The trial has been prospectively registered on the Australian New Zealand Clinical Trials Registry as ACTRN12623000502639 on 17/05/2023. |
| format | Article |
| id | doaj-art-e49c791e986b4ffdb0f7c4b4a10ecdda |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-e49c791e986b4ffdb0f7c4b4a10ecdda2025-02-03T09:40:11ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-090370Double-blind, randomised, placebo-controlled trial to evaluate the effectiveness of late gestation oral melatonin supplementation in reducing induction of labour rates in nulliparous women: the MyTIME study protocolMiranda Davies-Tuck0Emily Callander1Mary Sharp2Scott W White3Dorota A Doherty4Jane Warland5Zoe Bradfield6Lesley Kuliukas7Monique Rose8Amber Pettitt9Kylie Ekin10JA Keelan11Obstetrics and Gynaecology, Monash University School of Clinical Sciences at Monash Health, Clayton, Victoria, Australia10 School of Public Health, Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia2 King Edward Memorial Hospital for Women Perth, Subiaco, Western Australia, Australia3 The University of Western Australia, Perth, Australia7 School of Women’s and Infants’ Health, University of Western Australia, Perth, Western Australia, Australia3 The University of Adelaide Faculty of Health and Medical Sciences, Adelaide, South Australia, AustraliaCurtin University, Australia1 Curtin University - Perth Bentley Campus, Perth, Western Australia, Australia1 Curtin University - Perth Bentley Campus, Perth, Western Australia, Australia1 Curtin University - Perth Bentley Campus, Perth, Western Australia, Australia1 Curtin University - Perth Bentley Campus, Perth, Western Australia, Australia3 The University of Western Australia, Perth, AustraliaIntroduction Around the world, rates of induction of labour (IOL) among nulliparous mothers have increased in the last 10 years. In Australia, rates have increased over the last decade by 43%, from 32% to 46%. There is growing concern about the rapid rise in IOL before 41 weeks for nulliparous women without medical complications because of the associated increased rates of caesarean section, reduced satisfaction with birth, and birth trauma. Melatonin potentiates the action of oxytocin and may promote the spontaneous onset of labour; therefore, we will test the hypothesis that exogenous melatonin supplementation in late pregnancy will reduce the rate of labour induction by 30% or more.Methods and analyses This is a double-blind, randomised, placebo-controlled trial in nulliparous pregnant women to reduce IOL rates. We will randomise 530 women to receive either 3 mg oral melatonin or placebo daily from 39+0 weeks’ gestation until they give birth. The primary endpoint will be IOL rate after 39 weeks post enrolment. Secondary endpoints will include the following: interval between administration of trial medication and birth; a range of maternal and neonatal outcomes, including birth outcomes; breastfeeding on discharge, at 10 days and at 2 months; maternal satisfaction; child developmental outcomes at 2 months of age; and cost-effectiveness of melatonin compared with standard care. All data will be analysed by intention to treat.Ethics and dissemination The study is approved by the Western Australia Health Central Human Research Ethics Committee (RGS0000006283). Trial findings will be disseminated through conference presentations and peer-reviewed publications.Trial registration number The trial has been prospectively registered on the Australian New Zealand Clinical Trials Registry as ACTRN12623000502639 on 17/05/2023.https://bmjopen.bmj.com/content/15/1/e090370.full |
| spellingShingle | Miranda Davies-Tuck Emily Callander Mary Sharp Scott W White Dorota A Doherty Jane Warland Zoe Bradfield Lesley Kuliukas Monique Rose Amber Pettitt Kylie Ekin JA Keelan Double-blind, randomised, placebo-controlled trial to evaluate the effectiveness of late gestation oral melatonin supplementation in reducing induction of labour rates in nulliparous women: the MyTIME study protocol BMJ Open |
| title | Double-blind, randomised, placebo-controlled trial to evaluate the effectiveness of late gestation oral melatonin supplementation in reducing induction of labour rates in nulliparous women: the MyTIME study protocol |
| title_full | Double-blind, randomised, placebo-controlled trial to evaluate the effectiveness of late gestation oral melatonin supplementation in reducing induction of labour rates in nulliparous women: the MyTIME study protocol |
| title_fullStr | Double-blind, randomised, placebo-controlled trial to evaluate the effectiveness of late gestation oral melatonin supplementation in reducing induction of labour rates in nulliparous women: the MyTIME study protocol |
| title_full_unstemmed | Double-blind, randomised, placebo-controlled trial to evaluate the effectiveness of late gestation oral melatonin supplementation in reducing induction of labour rates in nulliparous women: the MyTIME study protocol |
| title_short | Double-blind, randomised, placebo-controlled trial to evaluate the effectiveness of late gestation oral melatonin supplementation in reducing induction of labour rates in nulliparous women: the MyTIME study protocol |
| title_sort | double blind randomised placebo controlled trial to evaluate the effectiveness of late gestation oral melatonin supplementation in reducing induction of labour rates in nulliparous women the mytime study protocol |
| url | https://bmjopen.bmj.com/content/15/1/e090370.full |
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