EVALUATION OF THE EFFECT OF ACTIVE WARMING APPLIED TO THE MOTHER DURING CESAREAN SECTION ON POST-BREASTFEEDING OUTCOMES: A RANDOMIZED CONTROLLED STUDY

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-01-31

Brief Summary

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Hypothermia is a complication of cesarean section and a cause of breastfeeding problems. Preventing maternal hypothermia is one of the goals of the enhanced postoperative recovery (ERAS) protocol and is important for the health of both mother and baby. This clinical trial aims to determine the effects of active warming during and after cesarean delivery on breastfeeding outcomes, thermal comfort, and perceived insufficient milk supply.

The primary questions it aims to answer are:

1. To evaluate the effect of active warming during cesarean delivery on mothers' perception of thermal comfort.
2. To evaluate the effect of active warming after cesarean delivery on mothers' perceived insufficient milk supply.
3. To determine the effect of active warming after cesarean delivery on breastfeeding success.

Participants:

Warming will be provided using an active warming bed during cesarean delivery (45 minutes). Warming will continue in the postpartum care unit (45 minutes).

The control group will not receive any warming and will receive the hospital's standard care procedure.

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Detailed Description

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Conditions

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Cesarean Resection Breastfeeding Thermal Comfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, controlled, parallel-group interventional study evaluating the effect of active warming applied to mothers during and after cesarean delivery on early postpartum breastfeeding outcomes. Participants will be randomly assigned, via computer-generated allocation, to either the intervention group receiving active warming or the control group receiving standard care without warming. The study will be conducted in a \[single-blind / open-label\] manner. The primary objective is to assess the effect of active warming on breastfeeding success, thermal comfort, and perceived insufficient milk supply.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

Active warming group

Group Type EXPERIMENTAL

active warming

Intervention Type OTHER

During the cesarean section, heating will be applied at 37 degrees. (45 minutes)

Carbon fiber resistive heating pads are reusable, where a low-voltage electric current flows, causing heat to accumulate in the carbon fibers that make up the blanket's filling. A heating pad will be used to warm participants. This pad has a control unit, is 120 cm long, and is suitable for operating room conditions. It is safe and operates at low voltage. It heats to a maximum of 40 degrees Celsius. In this study, heating will be used to a temperature of 37 degrees Celsius.

active warming II

Intervention Type OTHER

After the cesarean section, heating will be applied to the recovery area at 37 degrees. (45 minutes)

Carbon fiber resistive heating pads are reusable, where a low-voltage electric current flows, causing heat to accumulate in the carbon fibers that make up the blanket's filling. A heating pad will be used to warm participants. This pad has a control unit, is 120 cm long, and is suitable for operating room conditions. It is safe and operates at low voltage. It heats to a maximum of 40 degrees Celsius. In this study, heating will be used to a temperature of 37 degrees Celsius.

Control

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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active warming

During the cesarean section, heating will be applied at 37 degrees. (45 minutes)

Carbon fiber resistive heating pads are reusable, where a low-voltage electric current flows, causing heat to accumulate in the carbon fibers that make up the blanket's filling. A heating pad will be used to warm participants. This pad has a control unit, is 120 cm long, and is suitable for operating room conditions. It is safe and operates at low voltage. It heats to a maximum of 40 degrees Celsius. In this study, heating will be used to a temperature of 37 degrees Celsius.

Intervention Type OTHER

active warming II

After the cesarean section, heating will be applied to the recovery area at 37 degrees. (45 minutes)

Carbon fiber resistive heating pads are reusable, where a low-voltage electric current flows, causing heat to accumulate in the carbon fibers that make up the blanket's filling. A heating pad will be used to warm participants. This pad has a control unit, is 120 cm long, and is suitable for operating room conditions. It is safe and operates at low voltage. It heats to a maximum of 40 degrees Celsius. In this study, heating will be used to a temperature of 37 degrees Celsius.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Over 18 years of age
* Primiparous, singleton pregnancy
* Gestational age \>37 weeks, elective cesarean section under spinal anesthesia
* No issues with breastfeeding the baby or herself during the postpartum period
* Voluntarily participating

Exclusion Criteria

* Those with a gestational age of less than 37 weeks,
* Those with an urgent delivery decision or those with accompanying comorbidities (severe preeclampsia, placenta previa, placental abruption, umbilical cord prolapse, fetal distress),
* those with multiple pregnancies,
* those with a core body temperature above 37.5 °C,
* those who started cesarean delivery with spinal anesthesia and later switched to general anesthesia due to complications,
* those with known impaired thermoregulation or thyroid disorder

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Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes