UnknownNot Applicable

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

Tanzania562 participantsStarted 2024-02-14

Plain-language 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

Who can participate

Age range

30 Minutes

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infants born by planned CS, 37-42 weeks gestational age Exclusion Criteria: * infants with significant congenital malformations influencing cardiopulmonary transition * infants whose mother has gestational diabetes, pre-eclampsia, eclampsia * infants where immediate cord clamping is needed due to resuscitation of the baby or mother * when spontaneous contractions before the cesarean section is done. * KCF will not be done to infants who will start breathing instantly after being extracted from the uterus so as not to interfere with their breathing efforts

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

respiratory distress

Timeframe: 24 hours

Trial details

NCT IDNCT06270823

SponsorKilimanjaro Clinical Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-14

Contact for this trial

Febronia L Shirima, MD

+255714143368 febbylaw17@gmail.com

View on ClinicalTrials.gov More Transient Tachypnea of the Newborn trials