Study of Pregnancy And Neonatal Health (SPAN)

Summary

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.

Conditions

• Gestational Diabetes Mellitus

Interventions

PROCEDURE

Childbirth

Induction or planned cesarean

Sponsors & Collaborators

• Ochsner Health System

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Intermountain Health Care, Inc.

  collaborator OTHER

• Duke University

  collaborator OTHER

• Inova Fairfax Hospital

  collaborator OTHER

• University of Utah

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Technical Resources International, Inc.

  collaborator UNKNOWN

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

  lead NIH

Principal Investigators

• Katherine L Grantz, MD, MS · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-01-20

Primary Completion

2024-12-16

Completion

2024-12-16

Countries

• United States

Study Locations