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Optimal Timing of Childbirth for Gestational Diabetes (SPAN Trial)

N/A
Recruiting
Led By Katherine L Grantz, MD, MS
Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 Years
Verified diagnosis of Gestational Diabetes Mellitus (GDM) with abnormal glucose levels or meeting other criteria for poor control
Must not have
Genetic disorders, aneuploidy and known major fetal anomalies
Pre-gestational diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery through discharge
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves timing of childbirth rather than medication or surgical intervention, there are no direct side effects from treatments being tested. However, general risks associated with childbirth may apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with gestational diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have genetic disorders or major fetal anomalies.
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I had diabetes before becoming pregnant.
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My newborn has an infection linked to serious health issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~delivery through newborn discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and delivery through newborn discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
Birth Injuries
+5 more
Secondary study objectives
Perinatal death
Duration of Neonatal hospital stay
Duration of maternal hospital stay
+21 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

University of Alabama at BirminghamOTHER
1,646 Previous Clinical Trials
2,335,934 Total Patients Enrolled
Duke UniversityOTHER
2,455 Previous Clinical Trials
2,965,102 Total Patients Enrolled
Technical Resources International, Inc.UNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Childbirth 2023 Treatment Timeline for Medical Study. Trial Name: NCT05515744 — N/A
~4045 spots leftby Dec 2027
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