Clinical trial NCT03899597: The Role of ARTificial Uterine CONtractions in Perinatal Respiratory Morbidity of Term Infants Delivered by Elective Caesarean Section
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neonatal Respiratory Distress
Lead sponsor: Institute for the Care of Mother and Child, Prague, Czech Republic
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Incidence of neonatal respiratory morbidity
timeFrame: First 24 hours after delivery
Secondary outcomes:
measure: Oxytocin challenge test effectivity
timeFrame: Before elective caesarean section
measure: Oxytocin challenge test safety and feasibility
timeFrame: Before elective caesarean section
measure: Maternal blood loss
timeFrame: During caesarean section
measure: Total duration of surgery
timeFrame: Time of caesarean section
measure: Lamellar body count in amniotic fluid
timeFrame: During caesarean section
measure: Incidence of transitory tachypnoea of the newborn
timeFrame: First 24 hours after delivery
measure: Incidence of respiratory distress syndrome
timeFrame: First 24 hours after delivery
measure: Incidence of perinatal hypoxia
timeFrame: First 24 hours after delivery
measure: Incidence of early onset sepsis
timeFrame: First 48 hours after delivery
measure: Incidence of significantly increased neonatal pulmonary vascular resistance
timeFrame: First 72 hours after delivery
measure: Incidence of persistent pulmonary hypertension of the newborn
timeFrame: First 24 hours after delivery
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute for the Care of Mother and Child
Study officials:
affiliation: Institute for the Care of Mother and Child, Prague, Czech Republic
name: Ivan Berka, MD
role: PRINCIPAL_INVESTIGATOR
References: