Oxytocin Administration Prior Planned Caesarean Section

NCT ID: NCT03693885

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2025-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

OCT-group

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.

Group Type: EXPERIMENTAL

Oxytocin challenge test (OCT)

Intervention Type: 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.

Control

standard procedure before planned caesarean section

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Basel

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tilo Burkhardt, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Obstetrics, University Hospital Zurich

Locations

University Hospital Zurich, Department of Obstetrics

Zurich, Canton of Zurich, Switzerland

Site Status: RECRUITING

Baden Cantonal Hospital

Baden, , Switzerland

Site Status: RECRUITING

University Hospital Basel

Basel, , Switzerland

Site Status: RECRUITING

Saint Gallen Cantonal Hospital

Sankt Gallen, , Switzerland

Site Status: RECRUITING

Winterthur Cantonal Hospital

Winterthur, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Tilo Burkhardt, MD

Role: CONTACT

tilo.burkhardt@usz.ch

+41 44 255 5192

Sven Wellmann, Prof

Role: CONTACT

sven.wellmann@ukbb.ch

+41 61 704 29 24

Facility Contacts

Tilo Burkhardt, MD

Role: primary

tilo.burkhardt@usz.ch

+41 44 255 51 92

Leonhard Schäffer, MD

Role: primary

leonhard.Schaeffer@ksb.ch

+41 56 486 35 07

Gwendolin Manegold-Brauer, MD

Role: primary

Gwendolin.Manegold-Brauer@usb.ch

+41 61 265 90 46

Sven Wellmann, Prof

Role: backup

sven.wellmann@ukbb.ch

+41 61 704 29 24

Tina Fischer, MD

Role: primary

tina.fischer@kssg.ch

+41 71 494 18 66

Leila Sultan-Beyer, MD

Role: primary

leila.sultan-beyer@ksw.ch

+41 52 266 27 61

References

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.

Reference Type: DERIVED

PMID: 33472211 (View on PubMed)

Other Identifiers

Lacarus

Identifier Type: -

Identifier Source: org_study_id