Oxytocin Administration Prior Planned Caesarean Section

Study Overview
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Brief Summary
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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

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

Conditions
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Respiratory Insufficiency Syndrome of Newborn, Breastfeeding Status

Intervention / Treatment
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* Other: Oxytocin challenge test (OCT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCT-group<br>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. | Other: Oxytocin challenge test (OCT)<br>* 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.<br>|
| No Intervention: Control<br>standard procedure before planned caesarean section | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caesarean section, Oxytocin challenge test