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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery through discharge
Awards & highlights

SPAN Trial 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.Check my eligibility
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.See study design
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.

SPAN Trial Eligibility Criteria

Inclusion Criteria

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

SPAN Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite of Neonatal Morbidity and Perinatal Mortality
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
+10 more
Secondary outcome measures
Birthweight
Perinatal death
Duration of Neonatal hospital stay
+40 more

SPAN 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?

Duke UniversityOTHER
2,363 Previous Clinical Trials
3,414,036 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,590 Previous Clinical Trials
2,274,904 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still recruiting participants for this experiment?

"The clinical trial in question is not currently enrolling new patients. The study was first posted on October 1st, 2020 and the most recent update was September 8th, 2020. There are 1246 other trials that are actively recruiting right now."

Answered by AI

At how many center is this research project being conducted?

"There are presently 8 active sites for this study. If you enroll, it is important to choose the location nearest to you from the list of Falls Church, Chapel Hill and Birmingham among others, in order to minimize travel requirements."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Pregnancy And Neonatal Health (SPAN)
2023. "Study of Pregnancy And Neonatal Health (SPAN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05515744.
~4300 spots leftby Dec 2027
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