Oxytocin Administration Prior Planned Caesarean Section

Respiratory Insufficiency Syndrome of Newborn Clinical Trial

Official title: Mild Induced Labour Prior to Planned Caesarean Delivery to Improve Neonatal and Maternal Outcome - a Randomized Trial

Status Recruiting

Clinical Trial Summary

Spontaneous vaginal delivery of a healthy infant provokes a unique surge in stress hormone concentrations (e.g. AVP (arginine vasopressin) /copeptin) incommensurable with child or adult levels measured in any other situation. In contrast, infants delivered by primary caesarean section without preceding labour have low stress hormone concentrations at birth unless other stressors are present, including chorioamnionitis or intrauterine growth restriction. Infants delivered by caesarean section after a trial of labour show copeptin concentrations between these two extremes.

Objectives:1) To reduce neonatal respiratory morbidity and admission to the Neonatal Intensive Care Unit and increase bonding and breastfeeding by triggering uterine contractions prior to planned caesarean delivery.

2) To collect prospectively weight data of infants in the first 6 months of life to validate and expand our online neonatal weight calculator.

Study design: Open label; randomised, placebo controlled trail Intervention: Oxytocin challenge test (OCT): Infusion of oxytocin 5 IU/500 ml Ringer® lactate at a rate of 12 ml/h and doubled every 10 min until three uterine contractions per 10-min interval are induced, at which point it will be stopped.

Primary endpoint:

• Incidence of neonatal respiratory morbidity

Secondary endpoints:

• Umbilical cord blood copeptin levels

• Postnatal neonatal weight change

• Breastfeeding status

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Breastfeeding Status
• Respiratory Insufficiency
• Respiratory Insufficiency Syndrome of Newborn

• NCT number: NCT03693885
• Study type: Interventional
• Source: University of Zurich
• Contact: Tilo Burkhardt, MD
• Phone: +41 44 255 5192
• Email: tilo.burkhardt@usz.ch
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Completion date: June 1, 2025