Maternal Body Temperature in Caesarean Section

The Effects of Maternal Body Temperature Levels on Postoperative Maternal and Neonatal Results: a Cross-Sectional Study

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.

Study Overview

• Status: Completed
• Conditions: Body Temperature Regulation
• Intervention / Treatment: Behavioral: Cesarean section

Detailed Description

Research questions

1. What is the prevalence of maternal hypothermia in women who deliver by cesarean section?
2. What are the effects of maternal hypothermia on postoperative maternal vital signs, pain, mobilization, nutrition, digestive system, thermal comfort, and breastfeeding in women who deliver by cesarean section?
3. What are the effects of maternal hypothermia on neonatal vital signs, Apgar score, first sucking activity, nutrition, oxygen, and intensive care unit requirements in women who deliver by cesarean section? The study will be conducted with an analytical cross-sectional design. The study population will consist of women who gave birth by planned cesarean section in a state hospital in Turkey between 10.01.2021 and 10.01.2022.

The data of the study will be collected using the Pregnant Women Information Form, Postoperative Maternal and Neonatal Follow-up Forms, Faces Pain Scale (FPS) and Thermal Comfort Perception Scale (TCPS).

Statistical analyzes of the data will be performed using IBM SPSS (IBM Corp., NY, USA). Descriptive statistics (number, percentage, mean, standard deviation) will be used to evaluate sociodemographic data. In the comparison of categorical variables, parametric tests (Chi-square, t test, etc.) will be used when the data are normally distributed, and nonparametric tests (Mann-Whitney U test, Kruskal-Walli test, etc.) and regression analysis will be used when the data are not normally distributed.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli, Turkey, 41380
    • Kocaeli University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Cesarean section	Behavioral: Cesarean section; In the study, the participants' postoperative hypothermia development status was monitored.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative hypothermia	Postoperative Day 0 (will be measured at 1st hour, 6th hour, 12th hour and 24th hour)

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Principal Investigator: Sena Dilek Aksoy, Associate Professor, Ph.D., Kocaeli University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2021
• Primary Completion (Actual): January 10, 2022
• Study Completion (Actual): January 10, 2022

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Estimated): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Cesarean section; Body Temperature Regulation; Maternal Health; Birth; Newborn Health
• Other Study ID Numbers: sdilek11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No