Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction

PHASE3RecruitingINTERVENTIONAL
Enrollment

336

Participants

Timeline

Start Date

May 29, 2019

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2027

Conditions
Fetal Growth RetardationStillbirth and Fetal DeathPregnancy Preterm
Interventions
OTHER

Placebo

Tablets, visually identical to the melatonin tablets, but containing no active ingredient are administered three times a day.

DRUG

Melatonin 10 MG

Melatonin 10 mg tablets will be administered three times a day, up to a maximum of 30 mg daily

Trial Locations (12)

1023

RECRUITING

Auckland Hospital, Auckland

2025

RECRUITING

Middlemore Hospital, Auckland

2050

RECRUITING

Royal Prince Alfred, Camperdown

2305

RECRUITING

John Hunter Hospital, Newcastle

3021

RECRUITING

Joan Kirner Hospital, Saint Albans

3052

RECRUITING

Royal Women's Hospital, Parkville

3084

RECRUITING

Mercy Hospital, Heidelberg

3168

RECRUITING

Monash Health, Clayton

4101

RECRUITING

Mater Misericordiae, South Brisbane

4215

RECRUITING

Gold Coast University Hospital, Southport

5006

RECRUITING

Women's and Children's Hospital, North Adelaide

6021

RECRUITING

Wellington Regional Hospital, Wellington

All Listed Sponsors
collaborator

National Health and Medical Research Council, Australia

OTHER

collaborator

Cerebral Palsy Alliance

OTHER

collaborator

Equity Trustees

UNKNOWN

lead

Monash University

OTHER