Keeping you warm during cesarean delivery
Randomized Control Trial Assessing Effectiveness of Perioperative Warming Measures in Parturients Undergoing Cesarean Delivery
NA · The University of Texas Health Science Center, Houston · NCT05015582
This test compares different warming methods for people having scheduled cesarean delivery to see how they affect the mother's and newborn's temperatures.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The University of Texas Health Science Center, Houston (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05015582 on ClinicalTrials.gov |
What this trial studies
This single-center interventional trial assigns patients scheduled for elective cesarean under neuraxial anesthesia to different perioperative warming strategies, including preoperative upper- or lower-body forced-air warming and warmed or room-temperature intravenous fluids, with some groups receiving intraoperative forced-air warming. Maternal core temperature and newborn temperature are measured before, during, and after delivery to track hypothermia and temperature changes. The study focuses on term, singleton pregnancies and excludes emergency procedures and preterm deliveries. Outcomes will compare how each warming approach affects maternal and neonatal thermal status and related sequelae.
Who should consider this trial
Good fit: People with a singleton pregnancy scheduled for an elective cesarean under neuraxial anesthesia at or after 37 weeks would be eligible.
Not a fit: Those undergoing emergency cesarean, deliveries before 37 weeks, or multiple gestations would not meet eligibility and are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, using the best warming approach could reduce maternal and newborn hypothermia and related complications during and after cesarean delivery.
How similar studies have performed: Forced-air warming and warmed intravenous fluids have reduced intraoperative hypothermia in other surgical and some obstetric studies, though improvements in newborn outcomes are less consistently shown.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * scheduled for elective cesarean section under neuraxial anesthesia * singleton pregnancy Exclusion Criteria: * gestational age of less than 37 week * emergency cesarean
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Stacy Norrell, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Stacy Norrell, MD
- Email: Stacy.Norrell@uth.tmc.edu
- Phone: (713) 500-6200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypothermia, Anesthesia, Hypothermia, Newborn, Hypothermia, Sequela