Oxytocin Administration Prior Planned Caesarean Section

NCT03693885 | Unknown DMC

• 1 other identifier: Lacarus
• Study Type: interventional
• Target: 1,450
• Locations: 1 country
• Sites: 5

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

Conditions

Respiratory Insufficiency Syndrome of Newborn; Breastfeeding Status

Keywords

caesarean section; Oxytocin challenge test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Umbilical cord blood copeptin levels

  blood sample within 30 minutes after birth

• Postnatal neonatal weight change

  postnatal day 1-4

• Breastfeeding status

  1 year

Study Arms (2)

OCT-group

EXPERIMENTAL

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.

Other: Oxytocin challenge test (OCT)

Control

NO INTERVENTION

standard procedure before planned caesarean section

Interventions

Oxytocin challenge test (OCT) OTHER

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.

OCT-group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton pregnancy \>34 weeks
• primary caesarean section, that is without preceding contractions or rupture of the membranes,
• absence of a contraindication to oxytocin

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead
• University of Basel: collaborator

Study Sites (5)

University Hospital Zurich, Department of Obstetrics

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Baden Cantonal Hospital

Baden, Switzerland

RECRUITING

University Hospital Basel

Basel, Switzerland

RECRUITING

Saint Gallen Cantonal Hospital

Sankt Gallen, Switzerland

RECRUITING

Winterthur Cantonal Hospital

Winterthur, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 33472211 DERIVED

Study Officials

• Tilo Burkhardt, MD

  Dept. of Obstetrics, University Hospital Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tilo Burkhardt, MD

CONTACT

+41 44 255 5192; tilo.burkhardt@usz.ch

Sven Wellmann, Prof

CONTACT

+41 61 704 29 24; sven.wellmann@ukbb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: October 3, 2018
• Study Start: January 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: June 1, 2025
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (5)