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Trials / Completed

CompletedNCT06725407

Maternal Body Temperature in Caesarean Section

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

Status
Completed
Phase
Study type
Observational
Enrollment
250 (actual)
Sponsor
Kocaeli University · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCesarean sectionIn the study, the participants' postoperative hypothermia development status was monitored.

Timeline

Start date
2021-01-10
Primary completion
2022-01-10
Completion
2022-01-10
First posted
2024-12-10
Last updated
2024-12-10

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06725407. Inclusion in this directory is not an endorsement.