Optimal Timing of Childbirth for Gestational Diabetes

(SPAN Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal delivery time for pregnant women with uncontrolled gestational diabetes, a type of diabetes that develops during pregnancy. Researchers will compare delivery times between 37 and 39 weeks to identify which option minimizes health risks for newborns. Women with gestational diabetes who have high blood sugar levels despite treatment and plan to deliver at the study site hospital may be suitable candidates for this trial. Participants will be randomly assigned to deliver at specified times to evaluate which timing offers the safest outcomes. As an unphased trial, this study provides an opportunity to contribute to important research that could improve delivery outcomes for future mothers and their babies.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that having a baby around 39 weeks is generally safe for mothers with gestational diabetes. Studies suggest this timing helps reduce risks for both mother and baby. Waiting too long can lead to complications, while delivering too early might not be ideal for the baby's development.

Timing delivery in pregnancies with gestational diabetes is crucial. It aims to lower the risk of newborn illness while ensuring the baby is ready for life outside the womb. Overall, previous research considers delivery between 37 and 39 weeks safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to pinpoint the optimal timing for childbirth in pregnancies complicated by gestational diabetes. Current practice often involves delivering around 39 to 40 weeks, but this study is exploring a range of timing from 37 to 39 weeks, using both induction and planned cesarean delivery. By evaluating different delivery windows, researchers hope to improve outcomes for both mothers and babies, potentially reducing complications associated with gestational diabetes. This could lead to more personalized and effective care, tailoring delivery timing to better manage the condition.

What evidence suggests that this trial's timing of delivery treatments could be effective for gestational diabetes?

Research shows that timing childbirth for women with gestational diabetes (GDM) is crucial. This trial will explore various delivery timing options. Studies suggest that delivering after 39 weeks can reduce newborn risks. The NICHD advises delivery between 34 and 39 weeks if blood sugar is poorly controlled. However, one study found that delivering after 39 weeks led to better outcomes for babies, reducing complications. Thus, waiting until after 39 weeks might benefit both mother and baby in managing GDM. ^{1 6 7 8 9}

Who Is on the Research Team?

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.

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 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?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10075038/

Gestational diabetes mellitus: The optimal time of delivery For pregnant women with poor glycemic control, NICHD recommends delivery between 34 and 39 + 6 wk of gestation[48], and ACOG states that delivery should be ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4967397/

Timing of delivery and pregnancy outcomes in women with ... Women with gestational diabetes commonly undergo induction of labor at term, but the risks and benefits of induction of labor are incompletely understood.

3. diabetesjournals.org diabetesjournals.org/diabetes/article/73/Supplement_1/1221-P/155274/1221-P-Optimal-Delivery-Timing-in-Pregnancies

1221-P: Optimal Delivery Timing in Pregnancies Complicated ... Conclusion: In pregnancies complicated by GDM, planned delivery after 39 weeks was associated with lower odds of neonatal morbidity compared to ...

4. nature.com nature.com/articles/s41598-025-93449-9

Comparative analysis of perinatal outcomes in pregnant ... Comparative analysis of perinatal outcomes in pregnant women with pregestational diabetes mellitus based on diagnostic timing.

5. academic.oup.com academic.oup.com/jcem/article/110/9/2405/8196670

Preexisting Diabetes and Pregnancy: An Endocrine Society ... Unfavorable pregnancy outcomes are common in individuals with preexisting diabetes mellitus (PDM) and are related to modifiable factors such as ...

6. ajog.org ajog.org/article/S0002-9378(17)32296-2/fulltext

995: Gestational Diabetes: is there an optimal delivery time? The data suggest that 39 weeks gestation is “safe” and an optimal time to deliver patients with GDM. Delivery should probably occur by 41 weeks gestation.

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa2214956

Treatment of Gestational Diabetes Mellitus Diagnosed ... In cohort studies, women with pregnancies complicated by early (<20 weeks' gestation) hyperglycemia showed accelerated fetal growth by 24 to 28 weeks' gestation ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2451965020300806

The timing of interventions in early life and long-term ... While GDM can immediately impact perinatal outcomes, it importantly heralds life-long and sizably increased risk of cardiometabolic disease for the child.

9. diabetesjournals.org diabetesjournals.org/care/article/48/Supplement_1/S306/157565/15-Management-of-Diabetes-in-Pregnancy-Standards

15. Management of Diabetes in Pregnancy: Standards of Care ... Pregnant individuals with type 1 diabetes have an increased risk of hypoglycemia in the first trimester and after delivery, and like all ...