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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neonatal Respiratory Distress
• Intervention / Treatment: Drug: Oxytocin; Other: Normal saline

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ivan Berka, MD; Phone Number: 0042296511807; Email: ivan.berka@upmd.eu
• Study Contact Backup: Name: Zbynek Stranak, MD; Phone Number: 0042296511806; Email: zbynek.stranak@upmd.eu

Study Locations

• Czechia
  • Prague, Czechia, 14700
    • Institute for the Care of Mother and Child
    • Contact: Ivan Berka, MD; Phone Number: 0042296511807; Email: ivan.berka@upmd.eu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Placebo Comparator: 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.	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.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxytocin challenge test effectivity	Contractions being induced (felt or CTG recorded) before elective caesarean section	Before elective caesarean section
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
Maternal blood loss	Defined as the difference in hemoglobin levels before and after surgery	During caesarean section
Total duration of surgery	Minutes	Time of caesarean section
Lamellar body count in amniotic fluid	Particles per microlitre	During caesarean section
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
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
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
Incidence of early onset sepsis	Clinical or proven (positive blood culture)	First 48 hours after delivery
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
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

Collaborators and Investigators

• Sponsor: Institute for the Care of Mother and Child, Prague, Czech Republic
• Investigators: Principal Investigator: Ivan Berka, MD, Institute for the Care of Mother and Child, Prague, Czech Republic

Study record dates

Study Major Dates

• Study Start (Anticipated): January 30, 2024
• Primary Completion (Anticipated): September 30, 2025
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: March 31, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: ARTCON Study Protocol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No