Ignite Creation Date:
2024-05-06 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03693885
Status:
RECRUITING
Last Update Posted:
2023-10-31
First Post:
2018-09-24
Brief Title:
Oxytocin Administration Prior Planned Caesarean Section
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Mild Induced Labour Prior to Planned Caesarean Delivery to Improve Neonatal and Maternal Outcome - a Randomized Trial
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Spontaneous vaginal delivery of a healthy infant provokes a unique surge in stress hormone concentrations eg 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
Objectives1 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 IU500 ml Ringer lactate at a rate of 12 mlh 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
Objectives1 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 IU500 ml Ringer lactate at a rate of 12 mlh 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None