A Prospective, Randomized and Placebo Controlled Trial Comparing the Role of ARTificial Uterine CONtractions and no Intervention in Perinatal Respiratory Morbidity of Term Infants Delivered by Elective Caesarean Section - ARTCON Study
Overview
- Phase
- Not Applicable
- Intervention
- Oxytocin
- Conditions
- Neonatal Respiratory Distress
- Sponsor
- Institute for the Care of Mother and Child, Prague, Czech Republic
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Incidence of neonatal respiratory morbidity
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
In this study, the investigators aim to investigate if artificial uterine contractions prior to elective caesarean section delivery may have an impact on the respiratory morbidity of term neonates.
Detailed Description
Accumulating evidence suggests that the respiratory morbidity of infants is lower if delivered by caesarean section after the spontaneous onset of uterine contractions, or after oxytocin exposure. Moreover, benefits for the mother due to stretching of the lower uterine segment and possible lower blood loss are plausible. In obstetrics, there is a well described and standardized way to induce artificial uterine contractions in order to predict fetal wellbeing and tolerance of labor, without inducing the labor itself. This is the oxytocin challenge test (OCT). Although the OCT has not been performed previously in the context of planned elective caesarean section deliveries, it is generally considered a safe procedure if appropriate monitoring is granted. Hence evaluation of the role of artificial uterine contractions in perinatal respiratory morbidity of term infants delivered by elective caesarean section is possible and of interest.
Investigators
Ivan Berka
Head of Neonatal Intensive Care Unit
Institute for the Care of Mother and Child, Prague, Czech Republic
Eligibility Criteria
Inclusion Criteria
- •Term/near-term pregnancy (36+0 - 41+6 weeks of gestation)
- •Planned delivery by elective caesarean section
- •Absence of any exclusion criteria
- •Informed consent obtained
Exclusion Criteria
- •Term premature rupture of membranes (TPROM)
- •Spontaneous onset of uterine contractions
- •Known serious congenital malformations
- •Placenta praevia/vasa praevia
- •Abnormal placental attachment
- •Intrauterine growth restriction (birth weight below 3rd centile for given gestational age and gender)
Arms & Interventions
artificial contractions (ARTCON) group
All participating patients in the intervention (ARTCON) group will undergo oxytocin exposure in the form of a continuous intravenous infusion according to dosage guidelines of The Czech Society of Obstetrics and Gynaecology. The exposure will take two hours to complete and should be finished at least one hour before elective caesarean section is performed in order for the assumed effects of physiological stress associated with labor to occur.
Intervention: Oxytocin
standard approach (SA) group
All participating patients in the control (SA) group will undergo placebo exposure in the form of a continuous intravenous infusion. The exposure will take two hours to complete and should be finished at least one hour before elective caesarean section is performed.
Intervention: Normal saline
Outcomes
Primary Outcomes
Incidence of neonatal respiratory morbidity
Time Frame: First 24 hours after delivery
Neonatal respiratory morbidity during the first 24 hours after delivery is defined as presence of transitory tachypnoea of the newborn, or respiratory distress syndrome, and/or persistent pulmonary hypertension of the newborn.
Secondary Outcomes
- Total duration of surgery(Time of caesarean section)
- Incidence of significantly increased neonatal pulmonary vascular resistance(First 72 hours after delivery)
- Maternal blood loss(During caesarean section)
- Incidence of early onset sepsis(First 48 hours after delivery)
- Lamellar body count in amniotic fluid(During caesarean section)
- Incidence of respiratory distress syndrome(First 24 hours after delivery)
- Oxytocin challenge test effectivity(Before elective caesarean section)
- Oxytocin challenge test safety and feasibility(Before elective caesarean section)
- Incidence of transitory tachypnoea of the newborn(First 24 hours after delivery)
- Incidence of perinatal hypoxia(First 24 hours after delivery)
- Incidence of persistent pulmonary hypertension of the newborn(First 24 hours after delivery)