Childbirth for Gestational Diabetes Mellitus (GDM)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Gestational Diabetes Mellitus (GDM)+2 More
Childbirth - Procedure
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial will study the best time to deliver for women with gestational diabetes, in order to reduce risk of illness and death for the newborn.

Eligible Conditions
  • Gestational Diabetes Mellitus (GDM)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Gestational Diabetes Mellitus (GDM)

Study Objectives

13 Primary · 43 Secondary · Reporting Duration: Pregnancy through Delivery

Antepartum pregnancy period through Newborn Discharge
Occurrence of Antepartum, intrapartum or neonatal death (Component of )
Delivery through Discharge
Incidence of Chorioamnionitis
Incidence of Maternal venous thromboembolism
Incidence of Preeclampsia, with or without severe features
Maternal hypertension
Maternal postpartum infection
Number of hours in labor and delivery unit
Occurrence of Maternal ICU Admission
Occurrence of Maternal lacerations
Occurrence of Postpartum hemorrhage
Use of antihypertensive drugs
Delivery through Newborn Discharge
Birthweight
Duration of Neonatal hospital stay
Duration of any respiratory support
Duration of moderate respiratory support
Incidence of Shoulder dystocia
Incidence of Therapeutic hypothermia
Incidence of Transfusion of blood products or blood in neonates
Incidence of large for gestational age and macrosomia
Incidence of moderate or higher neonatal respiratory support within 72 hours after birth (Component of )
Incidence of neonatal intensive care unit (NICU) > 1 day (24 hours) stay
Incidence of respiratory support less than moderate
Incidence of small for gestational age
Birth Injuries
Occurrence of Hyperbilirubinemia in Neonates
Occurrence of Hypoglycemia in neonates
Occurrence of Hypotension requiring pressor support (Component of )
Occurrence of Intracranial hemorrhage (Component of )
Occurrence of Meconium aspiration syndrome (Component of )
Occurrence of Neonatal encephalopathy (Component of )
Occurrence of Pneumonia (Component of )
Occurrence of Polycythemia in Neonates
Occurrence of Respiratory distress syndrome in Neonates
Occurrence of Seizures (Component of )
Occurrence of Sepsis (Component of )
Occurrence of Transient tachypnea of the newborn
Occurrence of hypertrophic cardiomyopathy (Component of )
Occurrence of neonatal intensive care unit (NICU) or intermediate care unit admission
Hospital discharge
Composite of Neonatal Morbidity and Perinatal Mortality
Pregnancy through Delivery
Incidence of induced labor
Incidence of planned cesarean
Incidence of spontaneous labor
Indication for cesarean
Indication for delivery including cesarean for suspected macrosomia
Indications for operative vaginal delivery
Occurrence of Cesarean delivery
Occurrence of Operative vaginal delivery
Occurrence of Placental abruption
Occurrence of Spontaneous vaginal delivery
Pregnancy through Discharge
Perinatal death
Incidence of Maternal Blood transfusion
Eclampsia
Occurrence of HELLP syndrome
Occurrence of Maternal Pulmonary edema
Occurrence of maternal death
Pregnancy through Newborn Discharge
Duration of maternal hospital stay

Trial Safety

Safety Progress

1 of 3

Other trials for Gestational Diabetes Mellitus (GDM)

Trial Design

7 Treatment Groups

Intervention Arm 2
1 of 7
Intervention Arm 4
1 of 7
Intervention Arm 3
1 of 7
Intervention Arm 1
1 of 7
Intervention Arm 5
1 of 7
Intervention Arm 6
1 of 7
Intervention Arm 7
1 of 7
Experimental Treatment

6450 Total Participants · 7 Treatment Groups

Primary Treatment: Childbirth · No Placebo Group · N/A

Intervention Arm 2
Procedure
Experimental Group · 1 Intervention: Childbirth · Intervention Types: Procedure
Intervention Arm 4
Procedure
Experimental Group · 1 Intervention: Childbirth · Intervention Types: Procedure
Intervention Arm 3
Procedure
Experimental Group · 1 Intervention: Childbirth · Intervention Types: Procedure
Intervention Arm 1
Procedure
Experimental Group · 1 Intervention: Childbirth · Intervention Types: Procedure
Intervention Arm 5
Procedure
Experimental Group · 1 Intervention: Childbirth · Intervention Types: Procedure
Intervention Arm 6
Procedure
Experimental Group · 1 Intervention: Childbirth · Intervention Types: Procedure
Intervention Arm 7
Procedure
Experimental Group · 1 Intervention: Childbirth · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pregnancy through delivery

Who is running the clinical trial?

University of North Carolina, Chapel HillOTHER
1,359 Previous Clinical Trials
3,920,618 Total Patients Enrolled
4 Trials studying Gestational Diabetes Mellitus (GDM)
314 Patients Enrolled for Gestational Diabetes Mellitus (GDM)
University of PennsylvaniaOTHER
1,816 Previous Clinical Trials
41,108,643 Total Patients Enrolled
2 Trials studying Gestational Diabetes Mellitus (GDM)
140 Patients Enrolled for Gestational Diabetes Mellitus (GDM)
Technical Resources International, Inc.UNKNOWN
Duke UniversityOTHER
2,154 Previous Clinical Trials
3,173,363 Total Patients Enrolled
1 Trials studying Gestational Diabetes Mellitus (GDM)
16 Patients Enrolled for Gestational Diabetes Mellitus (GDM)
University of Alabama at BirminghamOTHER
1,419 Previous Clinical Trials
2,211,215 Total Patients Enrolled
3 Trials studying Gestational Diabetes Mellitus (GDM)
1,830 Patients Enrolled for Gestational Diabetes Mellitus (GDM)
Intermountain Health Care, Inc.OTHER
133 Previous Clinical Trials
1,785,122 Total Patients Enrolled
2 Trials studying Gestational Diabetes Mellitus (GDM)
310 Patients Enrolled for Gestational Diabetes Mellitus (GDM)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
1,805 Previous Clinical Trials
2,228,793 Total Patients Enrolled
7 Trials studying Gestational Diabetes Mellitus (GDM)
27,379 Patients Enrolled for Gestational Diabetes Mellitus (GDM)
Ochsner Health SystemOTHER
86 Previous Clinical Trials
176,690 Total Patients Enrolled
1 Trials studying Gestational Diabetes Mellitus (GDM)
962 Patients Enrolled for Gestational Diabetes Mellitus (GDM)
University of UtahOTHER
990 Previous Clinical Trials
1,762,498 Total Patients Enrolled
Inova Fairfax HospitalOTHER
8 Previous Clinical Trials
728 Total Patients Enrolled
Katherine L Grantz, MD, MSPrincipal InvestigatorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility Criteria

Age 18+ · Female Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have one or more elevated fasting blood glucoses or three or more elevated post-prandial blood glucoses after receiving education about appropriate diet and lifestyle modification (e.g
You must be fluent in English or Spanish.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: October 16th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.