Acute Tocolysis With Terbutaline for Suspected Fetal Distress

Not Applicable

Completed

• Conditions: Nonreassuring Fetal Status
• Interventions: Drug: Terbutaline

• Registration Number: NCT05326269
• Lead Sponsor: Hospital Kemaman

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.

Study Timeline

• Study Start: 2017-04-23
• Primary Completion: 2019-09-15
• Study Completion: 2019-09-15
• Study First Submitted: 2022-03-22
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-05
• Last Update Submitted: 2022-04-05
• Study First Posted: 2022-04-13
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Terbutaline	Terbutaline 0.5 mls (0.25 mg) , subcutaneously
Control group	Terbutaline	Placebo (normal saline) 0.5 mls , subcutaneously

Primary Outcome Measures

Name	Time	Method
Neonatal acidosis	within 1 hour of delivery	Umbilical artery acidosis

Secondary Outcome Measures

Name	Time	Method
Neonatal Apgar score	5 minutes after delivery	Mean Apgar score at 5 minutes of life
Neonatal acid base status	within 1 hour of delivery	Mean umbilical artery pH \& base excess
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)
Maternal heart rate	Within 1 hours after drug administration	Mean maternal heart rate changes (before and after drug or placebo administration)
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

Trial Locations

Locations (1)

Hospital Kemaman; 🇲🇾 Kuala Terengganu, Terengganu, Malaysia