Clinical trial NCT06725407: Maternal Body Temperature in Caesarean Section
Official title: The Effects of Maternal Body Temperature Levels on Postoperative Maternal and Neonatal Results: a Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Temperature Regulation
Keywords: Cesarean section
Birth
Body Temperature Regulation
Maternal Health
Newborn Health
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative hypothermia
timeFrame: Postoperative Day 0 (will be measured at 1st hour, 6th hour, 12th hour and 24th hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Sena Dilek Aksoy, Associate Professor, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: