Clinical trial NCT03693885: Oxytocin Administration Prior Planned Caesarean Section
Official title: Mild Induced Labour Prior to Planned Caesarean Delivery to Improve Neonatal and Maternal Outcome - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Insufficiency Syndrome of Newborn
Breastfeeding Status
Keywords: caesarean section
Oxytocin challenge test
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Basel
First posted: 2018-10-03
Enrollment: 1450
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of neonatal respiratory morbidity
timeFrame: in the first 4 hours of life
Secondary outcomes:
measure: Umbilical cord blood copeptin levels
timeFrame: blood sample within 30 minutes after birth
measure: Postnatal neonatal weight change
timeFrame: postnatal day 1-4
measure: Breastfeeding status
timeFrame: 1 year
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Department of Obstetrics
state: ZH
city: Baden
country: Switzerland
facility: Baden Cantonal Hospital
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Saint Gallen
country: Switzerland
facility: Saint Gallen Cantonal Hospital
city: Winterthur
country: Switzerland
facility: Winterthur Cantonal Hospital
Study officials:
affiliation: Dept. of Obstetrics, University Hospital Zurich
name: Tilo Burkhardt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wellmann S, Manegold-Brauer G, Fischer T, Schaffer L, Gaertner VD, Malfertheiner SF, Burkhardt T. Improving Neonatal and Maternal Outcome by Inducing Mild Labor before Elective Cesarean Section: The Lacarus Randomized Controlled Trial. Neonatology. 2021;118(1):116-121. doi: 10.1159/000512752. Epub 2021 Jan 20.