Maternal Body Temperature in Caesarean Section

NCT06725407 | Completed

• 1 other identifier: sdilek11
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of maternal body temperature on the postpartum process and the newborn in innatal cesarean section is an important issue that needs to be emphasized. Hypothermia is defined as the patient's body temperature falling below 36.0 °C. Because hypothermia and shivering are frequently undesirable morbidities that occur during cesarean section. It can lead to many problems such as coagulopathy, increased transfusion requirement, surgical site infection, delayed metabolism of drugs, prolonged recovery, shivering and thermal discomfort. Many randomized controlled studies have been conducted on the heat regulation processes of women who gave birth by cesarean section, and maternal shivering and infection have been compared with parameters such as neonatal Apgar, blood pH and hypothermia. However, it is observational; data on care, breastfeeding, maternal mobilization and comfort are limited. The aim of this study was to determine the postoperative maternal and neonatal effects of maternal body temperature after cesarean section. An analytical cross-sectional study design will be used. All samples meeting the inclusion criteria of the study will be reached between 10.01.2021-10.01.2022. Research data will be collected using the pregnancy information form, postoperative maternal-neonatal follow-up form, Facial Pain Scale and Temperature Comfort Perception Scale. Research data will be collected using the IBM SPSS Statistic program.

Conditions

Body Temperature Regulation

Keywords

Cesarean section; Birth; Body Temperature Regulation; Maternal Health; Newborn Health

Outcome Measures

Primary Outcomes (1)

• Postoperative hypothermia

  Postoperative Day 0 (will be measured at 1st hour, 6th hour, 12th hour and 24th hour)

Study Arms (1)

Group 1

Cesarean section

Behavioral: Cesarean section

Interventions

Cesarean section BEHAVIORAL

In the study, the participants' postoperative hypothermia development status was monitored.

Group 1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women between the ages of 18-45 who have been given the decision to have a planned caesarean section.

You may qualify if:

• Participants who are 18 years of age or older,
• Able to answer the research questions,
• Without any contagious disease including middle ear infection,
• Volunteer

You may not qualify if:

• Those with clotting disorders,
• Thyroid disease,
• Those with a body mass index below 18.5,
• Those with mental problems that prevent them from answering questions,
• Those whose babies were born with anomalies,
• Those who had a stillbirth,
• Those who were given special heated blankets and fluids

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sena Dilek Aksoy, Associate Professor, Ph.D.

  Kocaeli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 10, 2024
• Study Start: January 10, 2021
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: December 10, 2024

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)