Study of Pregnancy And Neonatal Health (SPAN)
Purpose
This study will conduct a randomized trial among women with gestational diabetes (GDM). Study of Pregnancy And Neonatal health (SPAN), TIMing of dElivery (TIME) is a randomized trial that will recruit up to 3,450 pregnant women with uncontrolled GDM and randomize the timing of their delivery. Women with GDM who are approached for the trial and are found eligible but do not consent to participating in randomization for delivery will be asked to consent for chart review only (estimated additional n=3,000). The primary objective is to determine the best time to initiate delivery for GDM-complicated deliveries (defined as the time when risk of illness and death for the newborn is the lowest) between 37-39 weeks.
Condition
- Gestational Diabetes Mellitus
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
Aim 3 (GDM randomized trial, TIME) inclusion criteria: Women inclusion criteria: 1. Age ≥ 18 Years 2. Verified diagnosis of Gestational Diabetes Mellitus (GDM) with abnormal glucose levels*** or meeting other criteria for poor control, specifically any one of the following: Estimated fetal weight ≥90th percentile (LGA), Polyhydramnios, and or Demonstrate noncompliance or nonadherence as defined clinically, including missing visits, not keeping accurate log, etc. ***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. physical activity) 3. Accurate gestational age as verified by ultrasound 4. Singleton gestation 5. English or Spanish speaker 6. Plans to deliver at the study site hospital 7. Ability to provide informed consent to be randomized to initiation of delivery
Exclusion Criteria
Aim 3 (GDM randomized trial, TIME) exclusion criteria: 1. Pre-gestational diabetes* *will be defined as diabetes diagnosis before pregnancy OR before 13 weeks of gestation with a documented fasting plasma glucose ≥ 126 mg/dL, random plasma glucose ≥ 200 mg/dL, 2 hour post glucose ≥ 200 mg/dL during an oral glucose tolerance test (75 g glucose load), or hemoglobin A1c ≥ 6.5%.110. 2. Previous stillbirth defined as fetal demise ≥ 20 weeks of gestation 3. Self-reported history of alcohol dependency disorder and/or other drug/substance dependency in the past year 4. Teratogen exposure (e.g. cyclophosphamide, valproic acid, warfarin) 5. Known infectious diseases associated with neonatal morbidity (e.g. malaria, cytomegalovirus, rubella, toxoplasmosis, syphilis or Zika virus) 6. Genetic disorders, aneuploidy and known major fetal anomalies 7. Fetal demise 8. Pregnancies with concurrent conditions and other indications for earlier delivery will also be excluded. 9. Participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention Arm 1 |
Intervention Arm 1 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 0-2 days. |
|
|
Experimental Intervention Arm 2 |
Intervention Arm 2 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 3-5 days. |
|
|
Experimental Intervention Arm 3 |
Initiation of Delivery by induction or planned cesarean at 37 weeks 6 days to 38 weeks and 1 day. |
|
|
Experimental Intervention Arm 4 |
Intervention Arm 4 Experimental Initiation of Delivery by induction or planned cesarean at 38 weeks 2-4 days. |
|
|
Experimental Intervention Arm 5 |
Initiation of Delivery by induction or planned cesarean at 38 weeks 5 days to 39 weeks and 0 days. |
|
|
Experimental Intervention Arm 6 |
Intervention Arm 6 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 1-3 days. |
|
|
Experimental Intervention Arm 7 |
Intervention Arm 7 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 4-6 days. |
|
Recruiting Locations
Birmingham, Alabama 35233
Alan Tita
More Details
- Status
- Recruiting
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Detailed Description
This is a randomized clinical trial under an adaptive design nested in a larger observational study, among women who are diagnosed with uncontrolled gestational diabetes mellitus (GDM). Women from multiple clinical sites around the United States will be recruited into the study (n=3,450). Women with GDM who are approached for the trial and are found eligible but do not consent to participating to randomization for delivery will be asked to consent for chart review only (estimated additional n=3,000). The primary objective is to determine the optimal time to initiate delivery for GDM complicated deliveries (defined as the time when neonatal morbidity and perinatal mortality risk is the lowest) between 37-39 weeks (n=3,450 women). Newborn developmental and behavior outcomes, and anthropometric measures will also be assessed as secondary outcomes, as well as an exploratory analysis to investigate whether there are clinical, non-clinical or biochemical factors such as glucose measures that will further assist in refining the interval for optimizing time of GDM complicated deliveries relative to neonatal morbidity and perinatal mortality.