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NCT03473470
Evaluation of the Active Warming Effects on Maternal and Neonatal Outcome During Cesarean Delivery
NA trial testing forced air warming and warmed intravenous fluids in Hypothermia; Anesthesia in 165 participants. Status unknown.
1 September 2020
Quick facts
| Lead sponsor | University of Foggia |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 165 |
| Start date | 22 December 2016 |
| Primary completion | 1 September 2020 |
| Estimated completion | 30 November 2020 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- forced air warming and warmed intravenous fluids
- warmed intravenous fluids
Conditions studied
- Hypothermia; Anesthesia — all drugs for Hypothermia; Anesthesia →
Sponsor
University of Foggia
Who can join
18 and older, female only, with Hypothermia; Anesthesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A prospective randomized study of healthy term parturients undergoing cesarean delivery was designed to assess the impact of the active warming on perioperative and postoperative temperature. The main objective is to evaluate the maternal core temperature in the perioperative and postoperative period during cesarean delivery. The secondary objectives are to assess the incidence of maternal hypothermia, the incidence of maternal shivers, the evaluation of maternal thermal comfort, the neonatal temperature at birth, the Apgar score at 1 and 5 minutes, the umbilical pH, the evaluation of coagulative assessment in case of maternal hypothermia trough the use of thromboelastography. The patients are randomized into three groups: a group of no warmed patients, a second group of Active waming patients with iv fluids and lower body forced air warming and a third group of Active warming patients with only warmed iv fluids. The inclusion criteria are healthy parturients up to age 18. The exclusion criteria included parturients who develop fever, diabetes mellitus, BMI up to 40kg/ m2, coagulative disorders, pre eclampsia or eclampsia, all the factors that can cause intraoperative bleeding such as placental abruption or antecedent placenta overgrowth ( placenta previa).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effectiveness of Combined Strategies for the Prevention of Hypothermia Measured by Noninvasive Zero-Heat Flux Thermometer During Cesarean Section.
Cotoia A, Mariotti PS, Ferialdi C, Del Vecchio P, et al · · 2021 · cited 3× · PMID 35004715 · DOI 10.3389/fmed.2021.734768
Verify or expand the search:
- PubMed search for NCT03473470
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hypothermia; Anesthesia
Currently open trials in the same condition.
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- NCT05015582 — Perioperative Warming Measures in Cesarean Delivery · NA · recruiting
Other University of Foggia trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03473470 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Foggia
- Last refreshed: 14 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03473470.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing