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

Neonatal Respiratory Distress Clinical Trial

— ARTCON  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03899597
• Other study ID #: ARTCON Study Protocol
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: November 2022
• Source: Institute for the Care of Mother and Child, Prague, Czech Republic
• Contact: Ivan Berka, MD
• Phone: 0042296511807
• Email: ivan.berka[@]upmd.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Neonatal Respiratory Distress
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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.

Locations

Country	Name	City	State
Czechia	Institute for the Care of Mother and Child	Prague

Sponsors (1)

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

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of neonatal respiratory morbidity	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.	First 24 hours after delivery
Secondary	Oxytocin challenge test effectivity	Contractions being induced (felt or CTG recorded) before elective caesarean section	Before elective caesarean section
Secondary	Oxytocin challenge test safety and feasibility	CTG trace suggestive of hypoxia during oxytocin exposure. Subjectively unbearable pain and discomfort during oxytocin exposure.	Before elective caesarean section
Secondary	Maternal blood loss	Defined as the difference in hemoglobin levels before and after surgery	During caesarean section
Secondary	Total duration of surgery	Minutes	Time of caesarean section
Secondary	Lamellar body count in amniotic fluid	Particles per microlitre	During caesarean section
Secondary	Incidence of transitory tachypnoea of the newborn	Breathing rate above 60 per minute at least for 3 hours (3 consecutive measurements) and /or dyspnoea for at least two hours in the follow-up period (consecutive) and /or the need for oxygen therapy during the first 24 hours after birth.	First 24 hours after delivery
Secondary	Incidence of respiratory distress syndrome	Defined by need for ventilatory support in the first 24 hours after birth (nasal continuous positive airway pressure, mechanical ventilation) and X-ray examination results consistent with RDS diagnosis.	First 24 hours after delivery
Secondary	Incidence of perinatal hypoxia	Presence of diagnostic criteria of hypoxic-ischaemic encephalopathy: 5-min Apgar score of less than 5, need for delivery room intubation or CPR, umbilical cord arterial pH less than 7.00 and abnormal neurological signs such as hypotonic muscles or lack of sucking reflex	First 24 hours after delivery
Secondary	Incidence of early onset sepsis	Clinical or proven (positive blood culture)	First 48 hours after delivery
Secondary	Incidence of significantly increased neonatal pulmonary vascular resistance	Pulmonary vascular resistance measurements consist of measuring the right ventricular systolic pressure (RVSP), pulmonary artery pressure (PAP) and persistent ductus arteriosus (PDA) shunting (if present).	First 72 hours after delivery
Secondary	Incidence of persistent pulmonary hypertension of the newborn	Defined by marked pulmonary hypertension that causes hypoxemia secondary to right-to-left shunting of blood at the foramen ovale and ductus arteriosus.	First 24 hours after delivery