An interventional study of Oxytocin and Normal saline in Neonatal Respiratory Distress, sponsored by Institute for the Care of Mother and Child, Prague, Czech Republic. Not yet recruiting at 1 site in Czechia. Open to female participants. Per ClinicalTrials.gov, last updated 2022-11-02.
Sponsored by Institute for the Care of Mother and Child, Prague, Czech Republic · Not applicable, Interventional, and Prevention
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.
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.
1,179 studies on the registry are indexed under Respiratory Distress Syndrome, Newborn; 161 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 712 interventional studies indexed under Respiratory Distress Syndrome, Newborn.
Browse Respiratory Distress Syndrome, Newborn studies →Institute for the Care of Mother and Child, Prague, Czech Republic is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 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.
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.
Also known as: Placebo
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.
Time frame: First 24 hours after delivery
Oxytocin challenge test effectivity
Contractions being induced (felt or CTG recorded) before elective caesarean section
Time frame: 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.
Time frame: Before elective caesarean section
Maternal blood loss
Defined as the difference in hemoglobin levels before and after surgery
Time frame: During caesarean section
Total duration of surgery
Minutes
Time frame: Time of caesarean section
Lamellar body count in amniotic fluid
Particles per microlitre
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: First 24 hours after delivery
Incidence of early onset sepsis
Clinical or proven (positive blood culture)
Time frame: 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).
Time frame: 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.
Time frame: First 24 hours after delivery
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Respiratory Distress Syndrome, Newborn→
Institute for the Care of Mother and Child, Prague, Czech Republic