Acute Tocolysis With Terbutaline for Suspected Fetal Distress

Study Overview
=================
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.

Official Title
-----------------
Acute Tocolysis With Terbutaline vs Placebo Prior to Emergency Caesarean Delivery for Suspected Intrauterine Fetal Compromise

Conditions
-----------------
Nonreassuring Fetal Status

Intervention / Treatment
-----------------
* Drug: Terbutaline


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>Terbutaline 0.5 mls (0.25 mg) , subcutaneously | Drug: Terbutaline<br>* Subcutaneous injection<br>* Other names: beta mimetic;|
| Placebo Comparator: Control group<br>Placebo (normal saline) 0.5 mls , subcutaneously | Drug: Terbutaline<br>* Subcutaneous injection<br>* Other names: beta mimetic;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal acidosis | Umbilical artery acidosis | within 1 hour of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal acid base status | Mean umbilical artery pH & base excess | within 1 hour of delivery | 
| Neonatal Apgar score | Mean Apgar score at 5 minutes of life | 5 minutes after delivery | 
| Neonatal intensive care unit admission | Number of babies admitted to neonatal intensive care unit | Within 24 hours of delivery | 
| Maternal blood pressure | Mean maternal arterial pressure (before and after drug or placebo administration) | Within 1 hours after drug administration | 
| Maternal heart rate | Mean maternal heart rate changes (before and after drug or placebo administration) | Within 1 hours after drug administration | 
| Blood loss | Mean estimated blood loss | Within 24 hours of delivery | 
| Hematocrit change | Mean hematocrit changes before and after cesarean section | Within 24 hours of delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fetal resuscitation, acute tocolysis, fetal distress, cesarean section