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Oxytocin Administration Prior Planned Caesarean Section

NCT03693885 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1450

Last updated 2023-10-31

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • University of Basel

    collaborator OTHER

  • University of Zurich

    lead OTHER

Principal Investigators

  • Tilo Burkhardt, MD · Dept. of Obstetrics, University Hospital Zurich

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2024-12-31
Completion
2025-06-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03693885 on ClinicalTrials.gov