The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether melatonin supplementation improves glycemic control in pregnant women diagnosed with gestational diabetes mellitus (GDM).
The main question it aims to answer is:
Does melatonin supplementation help with glycemic control, especially in lowering fasting plasma glucose level?
Researchers will compare melatonin to a placebo (a look-alike substance that contains no melatonin) to see if melatonin works to improve glycemic control.
Participants will:
1. Take melatonin or a placebo every day after randomization until delivery 2. Visit the antenatal clinic once every 1 to 2 weeks for follow-ups
Women aged 18 to 45 years
Singleton pregnancy
A diagnosis of GDM from a 75-g OGTT during 24 to 28 gestational weeks, according to the IADPSG criteria, with at least fasting plasma glucose (FPG) ≥ 5.1 mmol/L
Intending to receive obstetric care and deliver in the study center
Use of melatonin 1 month before pregnancy or/and during pregnancy
Night shift work or exposed to jetlag on a regular basis during pregnancy
Contraindications to melatonin use, including hypersensitive or allergic to melatonin
Use of antidepressive or antipsychotic medications which can interfere with melatonin metabolism and/or elimination, such as fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, quinolones, and other CYP1A2 inhibitors; carbamazepine, rifampicin, and other CYP1A2 inducers; and zaleplon, zolpidem, zopiclone, and other non-benzodiazepine hypnotics
Obstetrics & Gynecology Hospital of Fudan University
Lead sponsor
West China Second University Hospital
Collaborator