6450 Participants Needed

Optimal Timing of Childbirth for Gestational Diabetes

(SPAN Trial)

Recruiting at 7 trial locations
EY
KL
Overseen ByKatherine L Grantz, MD, MS
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

KL

Katherine L Grantz, MD, MS

Principal Investigator

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

Are You a Good Fit for This Trial?

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.
See 2 more

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.
See 6 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Group I: Intervention Arm 7Experimental Treatment1 Intervention
Intervention Arm 7 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 4-6 days.
Group II: Intervention Arm 6Experimental Treatment1 Intervention
Intervention Arm 6 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 1-3 days.
Group III: Intervention Arm 5Experimental Treatment1 Intervention
Initiation of Delivery by induction or planned cesarean at 38 weeks 5 days to 39 weeks and 0 days.
Group IV: Intervention Arm 4Experimental Treatment1 Intervention
Intervention Arm 4 Experimental Initiation of Delivery by induction or planned cesarean at 38 weeks 2-4 days.
Group V: Intervention Arm 3Experimental Treatment1 Intervention
Initiation of Delivery by induction or planned cesarean at 37 weeks 6 days to 38 weeks and 1 day.
Group VI: Intervention Arm 2Experimental Treatment1 Intervention
Intervention Arm 2 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 3-5 days.
Group VII: Intervention Arm 1Experimental Treatment1 Intervention
Intervention Arm 1 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 0-2 days.

Find a Clinic Near You

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+
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