Optimal Timing of Childbirth for Gestational Diabetes

(SPAN Trial)

Recruiting at 7 trial locations

Overseen By Katherine L Grantz, MD, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Must not be taking: Teratogens

Disqualifiers: Pre-gestational diabetes, Stillbirth, Substance dependency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 37-39 weeks

6450 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Katherine L Grantz, MD, MS

Principal Investigator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility Criteria

The SPAN trial is for pregnant women over 18 with gestational diabetes who plan to deliver at the study site hospital. They must have a verified diagnosis of GDM, an accurate pregnancy timeline confirmed by ultrasound, and be English or Spanish speakers. Women with pre-gestational diabetes, substance dependency issues in the past year, or other health conditions that require early delivery are not eligible.

Inclusion Criteria

Plans to deliver at the study site hospital

Your pregnancy stage has been confirmed by ultrasound.

You are pregnant with only one baby.

Exclusion Criteria

You have experienced a fetal demise after 20 weeks of pregnancy in the past.

You have been exposed to substances that can harm a developing fetus.

I do not have genetic disorders or major fetal anomalies.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Randomized timing of delivery for women with gestational diabetes, with initiation of delivery by induction or planned cesarean at specified weeks

37-39 weeks

Follow-up

Participants are monitored for neonatal and maternal outcomes from delivery through newborn discharge

Up to 2 weeks post-delivery

Chart Review (optional)

For women who do not consent to randomization, chart review will be conducted to gather data

Treatment Details

Interventions

• Childbirth

Trial Overview This trial aims to find the optimal time for initiating childbirth in women with uncontrolled gestational diabetes between 37-39 weeks of pregnancy. The goal is to determine when starting delivery minimizes risks for newborns. Participants will be randomly assigned a time within this window.

Participant Groups

Group I: Intervention Arm 7 Experimental Treatment 1 Intervention

Intervention Arm 7 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 4-6 days.

Group II: Intervention Arm 6 Experimental Treatment 1 Intervention

Intervention Arm 6 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 1-3 days.

Group III: Intervention Arm 5 Experimental Treatment 1 Intervention

Initiation of Delivery by induction or planned cesarean at 38 weeks 5 days to 39 weeks and 0 days.

Group IV: Intervention Arm 4 Experimental Treatment 1 Intervention

Intervention Arm 4 Experimental Initiation of Delivery by induction or planned cesarean at 38 weeks 2-4 days.

Group V: Intervention Arm 3 Experimental Treatment 1 Intervention

Initiation of Delivery by induction or planned cesarean at 37 weeks 6 days to 38 weeks and 1 day.

Group VI: Intervention Arm 2 Experimental Treatment 1 Intervention

Intervention Arm 2 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 3-5 days.

Group VII: Intervention Arm 1 Experimental Treatment 1 Intervention

Intervention Arm 1 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 0-2 days.

Who Is Running the Clinical Trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Lead Sponsor

Trials

2,103

Recruited

2,760,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Technical Resources International, Inc.

Collaborator

Trials

2

Recruited

6,500+

Ochsner Health System

Collaborator

Trials

97

Recruited

91,900+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Intermountain Health Care, Inc.

Collaborator

Trials

142

Recruited

1,965,000+

Inova Fairfax Hospital

Collaborator

Trials

12

Recruited

7,700+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+