Acute Tocolysis With Terbutaline for Suspected Fetal Distress

Last updated: April 5, 2022
Sponsor: Hospital Kemaman
Overall Status: Completed

Phase

N/A

Condition

Pregnancy Complications

Birth Defects

Treatment

N/A

Clinical Study ID

NCT05326269
NMRR-16-1985-331
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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).

Study Design

Total Participants: 100
Study Start date:
April 23, 2017
Estimated Completion Date:
September 15, 2019

Study 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.

Connect with a study center

  • Hospital Kemaman

    Kuala Terengganu, Terengganu 24000
    Malaysia

    Site Not Available

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