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

NCT03473470 | Unknown

• 1 other identifier: 76/CE/2017
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Maternal and Neonatal Hypothermia, cesarean delivery

Outcome Measures

Primary Outcomes (1)

• incidence of hypothermia (body temperature < 36°C)

  to assess the incidence of maternal hypothermia during caesarean delivery

  From the date of randomization until the end of surgery, up to four hours of surgery

Secondary Outcomes (5)

• Incidence of maternal shivering

  From the date of randomization until the end of surgery, up to four hours of surgery

• Neonatal body temperature (T°C)

  From neonatal birth until five minutes after the birth

• Neonatal Apgar score

  From neonatal birth and until five minutes after the birth

• Incidence of maternal coagulative disorders

  From the date of randomization until the end of surgery, up to four hours of surgery

• maternal thermal comfort

  From the date of randomization until the end of surgery, up to four hours of surgery

Study Arms (3)

not warmed

NO INTERVENTION

Not warming system

warmed group 1

ACTIVE COMPARATOR

forced air warming and warmed intravenous fluids

Device: forced air warming and warmed intravenous fluids

warmed group 2

ACTIVE COMPARATOR

warmed intravenous fluids

Device: warmed intravenous fluids

Interventions

forced air warming and warmed intravenous fluids DEVICE

Use of warming system (forced air)

warmed group 1

warmed intravenous fluids DEVICE

Use of warming system to have warmed intravenous fluids

warmed group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Fever;
• Diabetes mellitus;
• BMI\> 40Kg/m²;
• Coaugulation disorders;
• Pre-eclampsia and eclampsia;
• Increased risk of intraoperative hemorrhage

Sponsors & Collaborators

• University of Foggia: lead

Study Sites (1)

Ospedali Riuniti

Foggia, Apulia, 71100, Italy

RECRUITING

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonella Cotoia, MD

  University of Foggia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonella Cotoia, MD

CONTACT

+393297174175; antonella.cotoia@unifg.it

Gilda Cinnella, MD

CONTACT

gilda.cinnella@unifg.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 22, 2018
• Study Start: December 22, 2016
• Primary Completion: September 1, 2020
• Study Completion: November 30, 2020
• Last Updated: September 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)