Neonatal Respiratory Distress
Conditions
Brief 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.
Interventions
DRUGOxytocin
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.
OTHERNormal 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.
Sponsors
Institute for the Care of Mother and Child, Prague, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of neonatal respiratory morbidity | First 24 hours after delivery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxytocin challenge test safety and feasibility | Before elective caesarean section | CTG trace suggestive of hypoxia during oxytocin exposure. Subjectively unbearable pain and discomfort during oxytocin exposure. |
| Maternal blood loss | During caesarean section | Defined as the difference in hemoglobin levels before and after surgery |
| Total duration of surgery | Time of caesarean section | Minutes |
| Lamellar body count in amniotic fluid | During caesarean section | Particles per microlitre |
| Incidence of transitory tachypnoea of the newborn | First 24 hours after delivery | 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. |
| Oxytocin challenge test effectivity | Before elective caesarean section | Contractions being induced (felt or CTG recorded) before elective caesarean section |
| Incidence of perinatal hypoxia | First 24 hours after delivery | 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 |
| Incidence of early onset sepsis | First 48 hours after delivery | Clinical or proven (positive blood culture) |
| Incidence of significantly increased neonatal pulmonary vascular resistance | First 72 hours after delivery | 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). |
| Incidence of persistent pulmonary hypertension of the newborn | First 24 hours after delivery | Defined by marked pulmonary hypertension that causes hypoxemia secondary to right-to-left shunting of blood at the foramen ovale and ductus arteriosus. |
| Incidence of respiratory distress syndrome | First 24 hours after delivery | 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. |
Countries
Czechia
Contacts
Primary ContactIvan Berka, MD
Backup ContactZbynek Stranak, MD
Outcome results
None listed