MedTrace Logo

Evaluation of the Active Warming Effects on Maternal and Neonatal Outcome During Cesarean Delivery

NCT03473470 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2020-09-14

No results posted yet for this study

Summary

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).

Conditions

  • Hypothermia; Anesthesia

Interventions

DEVICE

forced air warming and warmed intravenous fluids

Use of warming system (forced air)

DEVICE

warmed intravenous fluids

Use of warming system to have warmed intravenous fluids

Sponsors & Collaborators

  • University of Foggia

    lead OTHER

Principal Investigators

  • Antonella Cotoia, MD · University of Foggia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-22
Primary Completion
2020-09-01
Completion
2020-11-30

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03473470 on ClinicalTrials.gov