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| Name | Class |
|---|---|
| University of Basel | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCT-group | Experimental | 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. |
|
| Control | No Intervention | standard procedure before planned caesarean section |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin challenge test (OCT) | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tilo Burkhardt, MD | Contact | +41 44 255 5192 | tilo.burkhardt@usz.ch | |
| Sven Wellmann, Prof | Contact | +41 61 704 29 24 | sven.wellmann@ukbb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Tilo Burkhardt, MD | Dept. of Obstetrics, University Hospital Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Department of Obstetrics | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33472211 | Derived | Wellmann S, Manegold-Brauer G, Fischer T, Schaffer L, Gaertner VD, Malfertheiner SF, Burkhardt T. Improving Neonatal and Maternal Outcome by Inducing Mild Labor before Elective Cesarean Section: The Lacarus Randomized Controlled Trial. Neonatology. 2021;118(1):116-121. doi: 10.1159/000512752. Epub 2021 Jan 20. |
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| postnatal day 1-4 |
| Breastfeeding status | Percentage of children who are not, partially or full breastfed | 1 year |
| Baden Cantonal Hospital | Recruiting | Baden | Switzerland |
|
| University Hospital Basel | Recruiting | Basel | Switzerland |
|
| Saint Gallen Cantonal Hospital | Recruiting | Sankt Gallen | Switzerland |
|
| Winterthur Cantonal Hospital | Recruiting | Winterthur | Switzerland |
|