TerminatedNot Applicable

Intrapartum Glycemic Control in GDMA2

Stopped: Poor recruitment

United States2 participantsStarted 2023-05-22

Plain-language summary

This is a randomized, parallel, controlled, non-inferiority trial to assess the impact of a tight versus a more liberalized intrapartum glycemic control in gestational diabetic mothers on neonatal glycemia. National guidelines for the management of intrapartum glucose in women with GDM are lacking. This is likely due to the scarcity of high-quality data on the topic.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women 18 years or older * Non-anomalous singleton gestation * Gestational diabetes type A2 diagnosed at 24 weeks' gestation or beyond * Planned vaginal delivery at term at Inova Fairfax Women's Hospital Exclusion Criteria: * Women \< 18 years * Fetus with major congenital malformations * Twin or higher order gestation * Pre-existing diabetes mellitus * Exposure to antenatal or any systemic steroids 14 days or less prior to delivery * Preterm delivery * Scheduled cesarean birth * Intrapartum cesarean birth prior to 4-5 cm of cervical dilatation

What they're measuring

Initial neonatal glucose post delivery

Timeframe: first 2 hours of life

Trial details

NCT IDNCT05647798

SponsorInova Health Care Services

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-15

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