Oxytocin Administration Prior Planned Caesarean Section

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 24, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

January 1, 2019

Estimated Primary Completion Date

June 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Oxytocin Administration Prior Planned Caesarean Section

Official Title ^ICMJE

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

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

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.
No Intervention: Control
standard procedure before planned caesarean section

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

1450

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 31, 2022

Estimated Primary Completion Date

June 30, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Switzerland

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University of Zurich

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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