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
Parallel
Melatonin
Drug1. Melatonin tablets will be administered orally 0.5 to 1 hour before sleep and at least 2 hours after the last meal. 2. Participants will take 5 mg melatonin every night during the first week of intervention after randomization, followed by 10 mg melatonin every night from the second week until delivery.
Placebo
Other intervention1. Identical placebo tablets in terms of packaging, appearance, smell and taste will be administered orally 0.5 to 1 hour before sleep and at least 2 hours after the last meal. 2. Participants will take identical placebo tablets after randomization until delivery.
Change in fasting plasma glucose (FPG) from baseline to 36 to 38 gestational weeks
The primary outcome is defined as the change in FPG levels from baseline, measured at the time of OGTT performed between 24 and 28 gestational weeks, to follow-up assessment at 36 to 38 gestational weeks. For participants who deliver before 36 gestational weeks, the last available FPG measurement obtained will be used.
Change in glycated hemoglobin (HbA1c) from baseline to 36 to 38 gestational weeks
This outcome is defined as change in HbA1c levels from baseline, measured at the time of OGTT performed between 24 and 28 gestational weeks, to follow-up assessment at 36 to 38 gestational weeks.
Initiation of insulin therapy
This outcome is defined as the proportion of participants requiring initiation of insulin therapy.
Change in mean glucose levels assessed by continuous glucose monitoring (CGM)
This outcome is defined as the change in mean glucose levels measured by CGM at baseline and before delivery.
Gestational weight gain in late pregnancy
This outcome is defined as total gestational weight gain and the rate of weight gain from baseline to the last assessment prior to delivery.
Pregnancy complications
This outcome is defined as a series of pregnancy complications including but not limited to gestational hypertensive disorders and intrahepatic cholestasis of pregnancy.
Perinatal outcomes
This outcome is defined as a series of perinatal outcomes including but not limited to the percentages of macrosomia, large for gestational age, small for gestational age, neonatal hypoglycemia, birth trauma, cesarean section, postpartum hemorrhage, placenta abruption, and spontaneous premature rupture of membranes.
Click on the lead sponsor to view all of their trials.
Obstetrics & Gynecology Hospital of Fudan University
Lead sponsor
West China Second University Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
