Trial · NCT07369284
Melatonin for Glycemic Control in Gestational Diabetes Mellitus
NCT07369284, Phase 2, Not yet recruiting, Obstetrics & Gynecology Hospital of Fudan University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Melatonin for Glycemic Control in Gestational Diabetes Mellitus. Trials, record NCT07369284. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07369284
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Melatonin for Glycemic Control in Gestational Diabetes Mellitus
- NCT number
- NCT07369284
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 150 participants, estimated
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Conditions
- Gestational Diabetes
- Interventions
- Melatonin, Placebo
- First posted
- 2026-01-27
- Last updated
- 2026-01-27
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in fasting plasma glucose (FPG) from baseline to 36 to 38 gestational weeks | Baseline (24 to 28 gestational weeks), and 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. |
| Secondary | Change in glycated hemoglobin (HbA1c) from baseline to 36 to 38 gestational weeks | Baseline and 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. |
| Secondary | Initiation of insulin therapy | From baseline until delivery | This outcome is defined as the proportion of participants requiring initiation of insulin therapy. |
| Secondary | Change in mean glucose levels assessed by continuous glucose monitoring (CGM) | Baseline and 36 to 38 gestational weeks | This outcome is defined as the change in mean glucose levels measured by CGM at baseline and before delivery. |
| Secondary | Gestational weight gain in late pregnancy | From baseline until delivery | This outcome is defined as total gestational weight gain and the rate of weight gain from baseline to the last assessment prior to delivery. |
| Secondary | Incidence of intervention-related adverse events | From initiation of the intervention until 6 weeks postpartum | This outcome is defined as the proportion of participants reporting adverse events potentially related to study intervention, including but not limited to dizziness, hypersomnia, nausea, vomiting and hypoglycemia. Adverse events will be collected from participants' medication diaries and systematically assessed through participant self-report at each antenatal clinic visit. |
| Secondary | Impact of melatonin on fetal growth | From baseline until delivery | The antenatal use of melatonin on estimated fetal growth (grams) will be assessed using ultrasound biometry parameters performed every two to four weeks following trial recruitment until birth. |
| Secondary | Percentage of time in range, time above range, and time below range measured by CGM | Baseline and 36 to 38 gestational weeks | This outcome is defined as percentages of time in range, time above range, and time below range measured by CGM at baseline and before delivery. |
| Other | Pregnancy complications | From baseline until the end of follow-up at 6 weeks postpartum | This outcome is defined as a series of pregnancy complications including but not limited to gestational hypertensive disorders and intrahepatic cholestasis of pregnancy. |
| Other | Perinatal outcomes | From baseline until the end of follow-up at 6 weeks postpartum | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07369284
GET https://conductscience.org/api/trials/v1/NCT07369284/registered