Nonreassuring Fetal Status
Conditions
Keywords
fetal resuscitation, acute tocolysis, fetal distress, cesarean section
Brief summary
The trial was to determine the effect of administrating subcutaneous terbutaline prior to emergency caesarean delivery for suspected fetal distress
Detailed description
The trial was a double-blinded, placebo-controlled study using subcutaneous terbutaline for acute tocolysis prior to emergency caesarean delivery in suspected fetal distress. The intervention (subcutaneous terbutaline) was compared to placebo looking at the neonatal and maternal outcomes. The primary outcome was the proportion of babies with neonatal acidosis (based on umbilical artery blood sampling at delivery). Other outcome of interest were the mean cord pH and base excess, the Apgar score at 5 minutes after delivery, he proportion of babies requiring intubation and admission to the Neonatal Intensive Care Unit. The maternal outcomes of interest were the changes in mean arterial pressure (before and after the drug or placebo injection), the maternal heart rate changes, the estimated blood loss, and the hematocrit changes.
Interventions
DRUGTerbutaline
Subcutaneous injection
Sponsors
Hospital Kemaman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The participants are randomly assigned a number (generated using an online random number generator) and given an opaque envelope containing instructions for study drug or placebo administration. The envelope will be opened by a nurse who prepared the injection in a treatment room, separated from the Labour Suite. The doctors managing the cases, the surgeons who performed the surgeries, the anaesthetists and the patients themselves were blinded against the injection given
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* term singleton pregnancy * cephalic presentation * in labour with cervix dilatation \> 4cm and regular uterine contractions of 3 or more 10 min * abnormal fetal heart rate status diagnosed using standard electronic FHR according to NICE guideline (2014) * acceptance of participation by the signing of a written consent.
Exclusion criteria
* maternal cardiopathy * hyperthyroidism * abruptio placentae or other placental accidents * hypertensive disease of pregnancy * hyperstimulation with oxytocin * multiple gestation * abnormal fetus planned for conservative management * evidence of intrauterine growth restriction * patient on medication which will interact with terbutaline (tricyclic antidepressants, beta-blockers, diuretics and sympathomimetic medicine).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal acidosis | within 1 hour of delivery | Umbilical artery acidosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Apgar score | 5 minutes after delivery | Mean Apgar score at 5 minutes of life |
| Neonatal intensive care unit admission | Within 24 hours of delivery | Number of babies admitted to neonatal intensive care unit |
| Maternal blood pressure | Within 1 hours after drug administration | Mean maternal arterial pressure (before and after drug or placebo administration) |
| Neonatal acid base status | within 1 hour of delivery | Mean umbilical artery pH & base excess |
| Blood loss | Within 24 hours of delivery | Mean estimated blood loss |
| Hematocrit change | Within 24 hours of delivery | Mean hematocrit changes before and after cesarean section |
| Maternal heart rate | Within 1 hours after drug administration | Mean maternal heart rate changes (before and after drug or placebo administration) |
Countries
Malaysia
Outcome results
None listed