Breastfeeding Status, Respiratory Insufficiency Syndrome of Newborn
Conditions
Keywords
caesarean section, Oxytocin challenge test
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
Interventions
OTHEROxytocin 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
University of Basel
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of neonatal respiratory morbidity | in the first 4 hours of life | Percentage of infants to be monitored or admitted to neonatology for respiratory distress syndrome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Umbilical cord blood copeptin levels | blood sample within 30 minutes after birth | copeptin levels in pmol/l |
| Postnatal neonatal weight change | postnatal day 1-4 | Maximum neonatal weight change in percent of birth weight |
| Breastfeeding status | 1 year | Percentage of children who are not, partially or full breastfed |
Countries
Switzerland
Contacts
Primary ContactTilo Burkhardt, MD
Backup ContactSven Wellmann, Prof
Outcome results
None listed