Study of Pregnancy And Neonatal Health (SPAN)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-20

Study Completion Date

2024-12-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a randomized clinical trial under an adaptive design nested in a larger observational study, among women who are diagnosed with uncontrolled gestational diabetes mellitus (GDM). Women from multiple clinical sites around the United States will be recruited into the study (n=3,450). Women with GDM who are approached for the trial and are found eligible but do not consent to participating to randomization for delivery will be asked to consent for chart review only (estimated additional n=3,000). The primary objective is to determine the optimal time to initiate delivery for GDM complicated deliveries (defined as the time when neonatal morbidity and perinatal mortality risk is the lowest) between 37-39 weeks (n=3,450 women). Newborn developmental and behavior outcomes, and anthropometric measures will also be assessed as secondary outcomes, as well as an exploratory analysis to investigate whether there are clinical, non-clinical or biochemical factors such as glucose measures that will further assist in refining the interval for optimizing time of GDM complicated deliveries relative to neonatal morbidity and perinatal mortality.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gestational Diabetes Mellitus

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Gestational Diabetes Mellitus Delivery Timing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Childbirth

Induction or planned cesarean

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥ 18 Years
2. Verified diagnosis of Gestational Diabetes Mellitus (GDM) with abnormal glucose levels\*\*\* or meeting other criteria for poor control, specifically any one of the following: Estimated fetal weight ≥90th percentile (LGA), Polyhydramnios, and or Demonstrate noncompliance or nonadherence as defined clinically, including missing visits, not keeping accurate log, etc.

\*\*\*One or more elevated fasting blood glucoses OR three or more elevated post-prandial blood glucoses after receiving education about appropriate diet and lifestyle modification (e.g. physical activity)
3. Accurate gestational age as verified by ultrasound
4. Singleton gestation
5. English or Spanish speaker
6. Plans to deliver at the study site hospital
7. Ability to provide informed consent to be randomized to initiation of delivery

Exclusion Criteria

1. Pre-gestational diabetes\*

\*will be defined as diabetes diagnosis before pregnancy OR before 13 weeks of gestation with a documented fasting plasma glucose ≥ 126 mg/dL, random plasma glucose ≥ 200 mg/dL, 2 hour post glucose ≥ 200 mg/dL during an oral glucose tolerance test (75 g glucose load), or hemoglobin A1c ≥ 6.5%.110.
2. Previous stillbirth defined as fetal demise ≥ 20 weeks of gestation
3. Self-reported history of alcohol dependency disorder and/or other drug/substance dependency in the past year
4. Teratogen exposure (e.g. cyclophosphamide, valproic acid, warfarin)
5. Known infectious diseases associated with neonatal morbidity (e.g. malaria, cytomegalovirus, rubella, toxoplasmosis, syphilis or Zika virus)
6. Genetic disorders, aneuploidy and known major fetal anomalies
7. Fetal demise
8. Pregnancies with concurrent conditions and other indications for earlier delivery will also be excluded.
9. Participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Katherine L Grantz, MD, MS

Role: PRINCIPAL_INVESTIGATOR

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

Review additional registry numbers or institutional identifiers associated with this trial.

000737-CH

Identifier Type: -

Identifier Source: secondary_id

10000737

Identifier Type: -

Identifier Source: org_study_id

Study of Pregnancy And Neonatal Health (SPAN)

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Intervention Arm 1

Childbirth

Intervention Arm 2

Childbirth

Intervention Arm 3

Childbirth

Intervention Arm 4

Childbirth

Intervention Arm 5

Childbirth

Intervention Arm 6

Childbirth

Intervention Arm 7

Childbirth

Interventions

Childbirth

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Ochsner Health System

University of Pennsylvania

Intermountain Health Care, Inc.

Duke University

Inova Fairfax Hospital

University of Utah

University of Alabama at Birmingham

University of North Carolina, Chapel Hill

Technical Resources International, Inc.

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

Responsible Party

Principal Investigators

Katherine L Grantz, MD, MS

Locations

University of Alabama at Birmingham

Ochsner Baptist

University of North Carolina - Chapel Hill

Duke University Perinatal Research Center

University of Pennsylvania

Intermountain Healthcare

University of Utah

INOVA Fairfax Hospital

Countries

Other Identifiers

000737-CH

10000737