CompletedNot Applicable

Intact-cord Stabilisation and Physiology-based Cord Clamping in Caesarean Sections

Norway263 participantsStarted 2022-10-03

Plain-language summary

This is a feasibility study with historical control designed to evaluate whether delivery of the placenta prior to umbilical cord clamping at caesarean sections is a feasible, safe and acceptable way of facilitating intact-cord stabilisation of preterm and term newborn infants.

Who can participate

Age range32 Weeks – 42 Weeks

SexFEMALE

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: * live infants (singletons or dichorionic twins) born in gestational week 32+0 to 42+0 * delivered by CS in regional anaesthesia * immediate care may be planned with involved personnel prior to delivery * informed maternal consent is obtained (parental consent on behalf of the unborn child). Exclusion Criteria: * twins, triplets * significant congenital malformations * placenta complications with high risk of abnormal maternal blood loss * severe fetal distress requiring cesarean section in general anaesthesia (crash CS) * participation in any other clinical study within the last month * not sufficient time for preparations or collection of maternal/parental consent * mother does not comprehend Norwegian or English

What they're measuring

Intervention fidelity (cohort 1)

Timeframe: First 10 minutes after delivery

Intervention fidelity (cohort 2)

Timeframe: First 10 minutes after delivery

Trial details

NCT IDNCT05461950

SponsorHelse Møre og Romsdal HF

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2024-03-31

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