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Reducing Respiratory Distress After Elective Caesarean Birth Through Knee-chest-flexion: a Randomized Controlled Trial

NCT06270823 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 562

Last updated 2024-02-21

No results posted yet for this study

Summary

Planned caesarean birth is a risk factor for the development of neonatal respiratory distress commonly known as transient tachypnoea of the newborn. This is due to the absence of labor physiology which facilitates the clearance of fetal lung fluid. We hypothesized that by mimicking flexion induced by uterine contractions by manually performing knee-to-chest flexion directly at birth to achieve expulsion of excess lung liquid, we could reduce the incidence of respiratory distress in term children born by planned CS.

The goal of this clinical trial is to test whether performing a knee-to-chest flexion maneuver directly after elective caesarean section will decrease the incidence of respiratory distress in term infants when compared to the standard care

Conditions

  • Transient Tachypnea of the Newborn

Interventions

PROCEDURE

Knee-to-chest-flexion manoeuvre

The obstetrician will place one hand at the neck and shoulder of the baby and gently bend the infant into dorsiflexion while with the other hand bending the hips and knees against the abdomen and chest (squatting into fetal position). This holding position will be continued for 30 seconds, while compression of the umbilical cord is avoided to maintain an undisturbed umbilical circulation to and from the infant during KCF.

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • Kilimanjaro Clinical Research Institute

    lead OTHER

Principal Investigators

  • Bariki Mchome, PhD · Kilimanjaro Christian Medical Centre

  • Blandina T Mmbaga, PhD · Kilimanjaro Clinical Research Institute

  • Febronia L Shirima, MD · Kilimanjaro Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
30 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-14
Primary Completion
2025-02-14
Completion
2025-02-14

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06270823 on ClinicalTrials.gov