Active warming during cesarean to improve maternal comfort and breastfeeding outcomes
EVALUATION OF THE EFFECT OF ACTIVE WARMING APPLIED TO THE MOTHER DURING CESAREAN SECTION ON POST-BREASTFEEDING OUTCOMES: A RANDOMIZED CONTROLLED STUDY
This will test whether using an active warming bed during and after cesarean delivery helps first-time, term mothers feel warmer and have better breastfeeding outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Female |
| Sponsor | Kutahya Health Sciences University Academic / other |
| Locations | 1 site (Kütahya, None Selected) |
| Trial ID | NCT07331168 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study compares active warming applied during cesarean delivery and continued in the postpartum unit with usual care for primiparous women at term undergoing elective cesarean under spinal anesthesia. Warming is provided with an active warming bed for about 45 minutes during surgery and another 45 minutes postoperatively. Primary outcomes include mothers' thermal comfort, perceived insufficient milk supply, and measures of breastfeeding success. Participants with urgent deliveries, multiple gestation, significant comorbidities, fever, or thermoregulation disorders are excluded. The trial is conducted at Kütahya Health Sciences University and affiliated hospitals in Kütahya, Turkey.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 or older with a singleton, term pregnancy planning an elective cesarean under spinal anesthesia who are first-time mothers and willing to breastfeed.
Not a fit: Patients with urgent or complicated deliveries, multiple pregnancies, preexisting thermoregulation or thyroid disorders, a core temperature above 37.5 °C, or those converted to general anesthesia are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, active warming could reduce maternal hypothermia, increase comfort, and improve early breastfeeding outcomes after cesarean delivery.
How similar studies have performed: Perioperative active warming has been shown to reduce hypothermia and improve thermal comfort in other surgical settings, but evidence specifically linking warming to improved post-cesarean breastfeeding is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Translated with DeepL.com (free version) \-
Where this trial is running
Kütahya, None Selected
- Kütahya Health Sciences University — Kütahya, None Selected, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Havva Yeşildere Sağlam, PhD
- Email: havva.yesilderesaglam@ksbu.edu.tr
- Phone: 0 (274) 260 00 43
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.