Oxytocin Administration Prior Planned Caesarean Section

October 26, 2023 updated by: University of Zurich

Mild Induced Labour Prior to Planned Caesarean Delivery to Improve Neonatal and Maternal Outcome - a Randomized Trial

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

Study Overview

Study Type

Interventional

Enrollment (Estimated)

1450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Baden, Switzerland
        • Recruiting
        • Baden Cantonal Hospital
        • Contact:
      • Basel, Switzerland
      • Saint Gallen, Switzerland
        • Recruiting
        • Saint Gallen Cantonal Hospital
        • Contact:
      • Winterthur, Switzerland
        • Recruiting
        • Winterthur Cantonal Hospital
        • Contact:
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich, Department of Obstetrics
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Control
standard procedure before planned caesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of neonatal respiratory morbidity
Time Frame: in the first 4 hours of life
Percentage of infants to be monitored or admitted to neonatology for respiratory distress syndrome
in the first 4 hours of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Umbilical cord blood copeptin levels
Time Frame: blood sample within 30 minutes after birth
copeptin levels in pmol/l
blood sample within 30 minutes after birth
Postnatal neonatal weight change
Time Frame: postnatal day 1-4
Maximum neonatal weight change in percent of birth weight
postnatal day 1-4
Breastfeeding status
Time Frame: 1 year
Percentage of children who are not, partially or full breastfed
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Tilo Burkhardt, MD, Dept. of Obstetrics, University Hospital Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

September 24, 2018

First Submitted That Met QC Criteria

October 2, 2018

First Posted (Actual)

October 3, 2018

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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