NCT03899597

The Role of ARTificial Uterine CONtractions in Perinatal Respiratory Morbidity of Term Infants Delivered by Elective Caesarean Section

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Institute for the Care of Mother and Child, Prague, Czech Republic · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Respiratory Distress

Interventions

Type	Name	Description
DRUG	Oxytocin	The intervention group (ARTCON) will receive the standard assignment for the elective caesarean section, but at least one hour before surgery oxytocin exposure will be performed with cardiotocographic (CTG) monitoring and obstetrical supervision.
OTHER	Normal saline	The control group (SA) will receive the standard assignment for the elective caesarean section, but at least one hour before surgery placebo exposure will be performed with cardiotocographic (CTG) monitoring and obstetrical supervision.

Timeline

• Start date: 2024-01-30
• Primary completion: 2025-09-30
• Completion: 2025-12-30
• First posted: 2019-04-02
• Last updated: 2022-11-02

Locations

1 site across 1 country: Czechia