Acute Tocolysis With Terbutaline for Suspected Fetal Distress

Sponsor

Hospital Kemaman (Other)

Overall Status

Completed

CT.gov ID

NCT05326269

Collaborator

(none)

100

Enrollment

Location

Arms

28.7

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The trial was to determine the effect of administrating subcutaneous terbutaline prior to emergency caesarean delivery for suspected fetal distress

Condition or Disease	Intervention/Treatment	Phase
Nonreassuring Fetal Status	Drug: Terbutaline	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, 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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 23, 2017

Actual Primary Completion Date :

Sep 15, 2019

Actual Study Completion Date :

Sep 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention group Terbutaline 0.5 mls (0.25 mg) , subcutaneously	Drug: Terbutaline Subcutaneous injection Other Names: beta mimetic
Placebo Comparator: Control group Placebo (normal saline) 0.5 mls , subcutaneously	Drug: Terbutaline Subcutaneous injection Other Names: beta mimetic

Arm

Intervention/Treatment

Active Comparator: Intervention group

Terbutaline 0.5 mls (0.25 mg) , subcutaneously

Drug: Terbutaline

Subcutaneous injection

Other Names:

beta mimetic

Placebo Comparator: Control group

Placebo (normal saline) 0.5 mls , subcutaneously

Drug: Terbutaline

Subcutaneous injection

Other Names:

beta mimetic

Outcome Measures

Primary Outcome Measures

Neonatal acidosis [within 1 hour of delivery]
Umbilical artery acidosis

Secondary Outcome Measures

Neonatal acid base status [within 1 hour of delivery]
Mean umbilical artery pH & base excess
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)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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).