Status:

COMPLETED

Immediate Skin-To-Skin Contact and Early Breastfeeding During Caesarean Section

Lead Sponsor:

Qingdao Municipal Hospital

Conditions:

Neonatal Hypoglycemia

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Background: Neonatal hypoglycemia is a prevalent and serious condition among late preterm and term infants, which can lead to severe neurodevelopmental consequences if not managed properly. Immediate ...

Detailed Description

Neonatal hypoglycemia is a common condition among late preterm and term infants. It can lead to severe neurodevelopmental consequences if not managed properly. Immediate skin-to-skin contact (SSC) and...

Eligibility Criteria

Inclusion

  • mothers aged 18 years or older with a singleton pregnancy, gestational age between 34+1 and 41+6 weeks.
  • undergoing elective cesarean section with epidural, subarachnoid block, or combined spinal-epidural anesthesia, willing to engage in mother-infant SSC during and after the surgery, without experiencing severe reactions to anesthesia like vomiting or shivering that could affect SSC.
  • having intention to breastfeed with no major contraindications (e.g., hepatitis B, syphilis, HIV, or other infectious diseases).
  • newborns with Apgar scores above 8 at 1 and 5 minutes, a strong sucking reflex, and no critical neonatal conditions requiring transfer.

Exclusion

  • serious pregnancy complications such as placenta previa, placenta accreta spectrum, eclampsia, and grade 3 or higher cardiac issues per NYHA standards.
  • challenges in initiating mother-infant SSC include emergencies such as neonatal asphyxia or respiratory distress, maternal excessive bleeding during surgery, and maternal infectious dermatoses.
  • previous breast surgeries such as biopsies or augmentations, nipple inversions complicating breastfeeding, or taking medications affecting lactation.

Key Trial Info

Start Date :

July 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 20 2024

Estimated Enrollment :

336 Patients enrolled

Trial Details

Trial ID

NCT06543160

Start Date

July 1 2023

End Date

July 20 2024

Last Update

August 7 2024

Active Locations (1)

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Qingdao Municipal Hospital

Qingdao, Shandong, China, 266000