SPAN trial randomizes delivery timing in GDM women to optimize neonatal health 37-39 weeks.
Background
Gestational diabetes mellitus (GDM) affects a significant number of pregnancies, increasing risks for both mother and neonate, including macrosomia, birth trauma, and neonatal hypoglycemia. While managing GDM is crucial, the optimal timing for delivery in cases of uncontrolled GDM remains a clinical challenge. Current guidelines often vary, leading to uncertainty regarding when to induce labor to minimize neonatal morbidity and mortality without increasing maternal complications. This study addresses this critical gap by systematically evaluating delivery timing.
Study Design
The Study of Pregnancy And Neonatal Health (SPAN), TIMing of dElivery (TIME) is a randomized trial recruiting up to 3,450 pregnant women with uncontrolled GDM. Participants will be randomized to different delivery timings between 37-39 weeks gestation. The primary objective is to determine the best time to initiate delivery for GDM-complicated pregnancies, defined as the time when risk of illness and death for the newborn is the lowest. An additional 3,000 eligible non-consenting women will undergo chart review.
Results
As a recruiting clinical trial, this study has not yet reported findings. The trial aims to generate robust evidence on the optimal timing of delivery for pregnancies complicated by uncontrolled gestational diabetes. Results are anticipated to provide specific data on neonatal health outcomes across different induction windows within the 37-39 week gestational period. The study's completion is projected for March 2028, with initial data expected thereafter.
Why It Matters
Optimizing delivery timing in GDM could significantly improve neonatal health outcomes, reducing complications like respiratory distress, hypoglycemia, and birth trauma. For clinicians, this trial promises to establish an evidence-based protocol for managing uncontrolled GDM pregnancies, potentially standardizing care and reducing variability in practice. For pregnant individuals with GDM, clearer guidance on delivery timing could alleviate anxiety and lead to safer births. This research is crucial for refining existing obstetric protocols and translating directly into improved clinical decision-making.
gestational diabetes
gdm
pregnancy
neonatal health
delivery timing
randomized trial