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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03693885
• Other study ID #: Lacarus
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: June 1, 2025

Study information

• Verified date: October 2023
• Source: University of Zurich
• Contact: Tilo Burkhardt, MD
• Phone: +41 44 255 5192
• Email: tilo.burkhardt[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1450
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Singleton pregnancy >34 weeks

• primary caesarean section, that is without preceding contractions or rupture of the membranes,

• absence of a contraindication to oxytocin

Exclusion Criteria:

• Chromosomal aberration

• malformation,

• IUGR,

• Nonreassuring fetal heart rate pattern,

• Placenta praevia,

• maternal substance abuse,

• infections,

• hypertension,

• preeclampsia,

• diabetes type I or II,

• autoimmune disease (antiphospholipid syndrome, lupus erythematosus, etc.),

• renal disease,

• history of more than one previous caesarean section.

Related Conditions & MeSH terms

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

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Switzerland	Baden Cantonal Hospital	Baden
Switzerland	University Hospital Basel	Basel
Switzerland	Saint Gallen Cantonal Hospital	Saint Gallen
Switzerland	Winterthur Cantonal Hospital	Winterthur
Switzerland	University Hospital Zurich, Department of Obstetrics	Zurich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of neonatal respiratory morbidity	Percentage of infants to be monitored or admitted to neonatology for respiratory distress syndrome	in the first 4 hours of life
Secondary	Umbilical cord blood copeptin levels	copeptin levels in pmol/l	blood sample within 30 minutes after birth
Secondary	Postnatal neonatal weight change	Maximum neonatal weight change in percent of birth weight	postnatal day 1-4
Secondary	Breastfeeding status	Percentage of children who are not, partially or full breastfed	1 year