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

Institute for the Care of Mother and Child, Prague, Czech Republic

Status: Not yet enrolling

Conditions: Neonatal Respiratory Distress

Treatments: Drug: Oxytocin; Other: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03899597

ARTCON Study Protocol

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

artificial contractions (ARTCON) group

Experimental group

Description:

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.

Treatment:

Drug: Oxytocin

standard approach (SA) group

Placebo Comparator group

Description:

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.

Treatment:

Other: Normal saline