Oxytocin Administration Prior Planned Caesarean Section

Not Applicable

Recruiting

• Conditions: Respiratory Insufficiency Syndrome of Newborn; Breastfeeding Status
• Interventions: Other: Oxytocin challenge test (OCT)

• Registration Number: NCT03693885
• Lead Sponsor: University of Zurich

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-03
• Study Start: 2019-01-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-31
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OCT-group	Oxytocin challenge test (OCT)	Oxytocin challenge test: Oxytocin 5 IU/500 ml Ringer® lactate will be infused at a rate of 12 ml/h and doubled every 10 min until it induced three uterine contractions per 10-min interval at which point it will stopped.

Primary Outcome Measures

Name	Time	Method
Incidence of neonatal respiratory morbidity	in the first 4 hours of life	Percentage of infants to be monitored or admitted to neonatology for respiratory distress syndrome

Secondary Outcome Measures

Name	Time	Method
Postnatal neonatal weight change	postnatal day 1-4	Maximum neonatal weight change in percent of birth weight
Umbilical cord blood copeptin levels	blood sample within 30 minutes after birth	copeptin levels in pmol/l
Breastfeeding status	1 year	Percentage of children who are not, partially or full breastfed

Trial Locations

Locations (5)

Baden Cantonal Hospital; 🇨🇭 Baden, Switzerland

University Hospital Zurich, Department of Obstetrics; 🇨🇭 Zurich, ZH, Switzerland

University Hospital Basel; 🇨🇭 Basel, Switzerland

Winterthur Cantonal Hospital; 🇨🇭 Winterthur, Switzerland

Saint Gallen Cantonal Hospital; 🇨🇭 Saint Gallen, Switzerland