Oxytocin Administration Prior Planned Caesarean Section

University of Zurich (UZH)

Status: Enrolling

Conditions: Respiratory Insufficiency Syndrome of Newborn; Breastfeeding Status

Treatments: Other: Oxytocin challenge test (OCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03693885

Lacarus

Details and patient eligibility

About

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

Enrollment: 1,450 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,450 participants in 2 patient groups

OCT-group

Experimental group

Description:

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.

Treatment:

Other: Oxytocin challenge test (OCT)

Control

No Intervention group

Description:

standard procedure before planned caesarean section