Mild induced labour prior to planned caesarean delivery to improve neonatal outcome - a randomized trial (Lacarus)
Phase 3
Withdrawn
- Conditions
- gezonde zwangerschap met sectio indicatie (electief)cesarean section
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
* singleton pregnancy
* ECS without preceding contractions or rupture of the membranes
* Absence of a contraindication to oxytocin.
* Informed Consent as documented by signature.
Exclusion Criteria
Non-inclusion criteria mother:
* Known or suspected unwillingness to follow the protocol
* Substance abuse (for example heroin, cocaine, amphetamine)
* Placenta praevia
* Clinical signs of infection
* Treated hypertension
* Preeclampsia
* Diabetes type I or II
* Steroid therapy during pregnancy
* Betablocker intake at inclusion
* Antenatal steroid administration for lung maturation
* A history of more than one previous caesarean section
Non-inclusion criteria fetus:
* Chromosomal aberration
* Malformation
* IUGR
* Nonreassuring fetal heart rate pattern
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint will be the rate of respiratory morbidity between infants<br /><br>in the study group (OCT prior ECS) and the control group (no OCT prior ECS).<br /><br>Neonatal respiratory morbidity is characterized by one or more of the following<br /><br>criteria, tachypnea (more than 60 breaths per minute), expiratory grunting,<br /><br>chest wall retractions, flaring of the nostrils, cyanosis, need for oxygen or<br /><br>any positive pressure support present for at least two hours within the first<br /><br>48 hours after birth. Corresponding diagnoses of neonatal respiratory morbidity<br /><br>are usually but not exclusively respiratory distress syndrome (RDS) or<br /><br>transient tachypnea of the newborn (TTN).<br /><br>Positive pressure support includes continuous positive airway pressure (CPAP)<br /><br>or high-flow nasal cannula or mechanical ventilation.<br /><br>Neonatal death within 48 hours after delivery are also included in the<br /><br>composite outcome as competing events.</p><br>
- Secondary Outcome Measures
Name Time Method