Acute Tocolysis With Terbutaline for Suspected Fetal Distress

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

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

Study Overview

• Status: Completed
• Conditions: Nonreassuring Fetal Status
• Intervention / Treatment: Drug: Terbutaline

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Terengganu
    • Kuala Terengganu, Terengganu, Malaysia, 24000
      • Hospital Kemaman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: Hospital Kemaman
• Investigators: Principal Investigator: Zahar A Zakaria, MD, Hospital Kemaman

Publications and helpful links

General Publications

• Patriarco MS, Viechnicki BM, Hutchinson TA, Klasko SK, Yeh SY. A study on intrauterine fetal resuscitation with terbutaline. Am J Obstet Gynecol. 1987 Aug;157(2):384-7. doi: 10.1016/s0002-9378(87)80178-3.
• Ingemarsson I, Arulkumaran S, Ratnam SS. Single injection of terbutaline in term labor. I. Effect on fetal pH in cases with prolonged bradycardia. Am J Obstet Gynecol. 1985 Dec 15;153(8):859-65. doi: 10.1016/0002-9378(85)90690-8.
• Leathersich SJ, Vogel JP, Tran TS, Hofmeyr GJ. Acute tocolysis for uterine tachysystole or suspected fetal distress. Cochrane Database Syst Rev. 2018 Jul 4;7(7):CD009770. doi: 10.1002/14651858.CD009770.pub2.
• Pullen KM, Riley ET, Waller SA, Taylor L, Caughey AB, Druzin ML, El-Sayed YY. Randomized comparison of intravenous terbutaline vs nitroglycerin for acute intrapartum fetal resuscitation. Am J Obstet Gynecol. 2007 Oct;197(4):414.e1-6. doi: 10.1016/j.ajog.2007.06.063.
• Buckley VA, Wu J, De Vries B. Outcomes following acute tocolysis prior to emergency caesarean section. Aust N Z J Obstet Gynaecol. 2020 Dec;60(6):884-889. doi: 10.1111/ajo.13170. Epub 2020 May 6.
• Magann EF, Cleveland RS, Dockery JR, Chauhan SP, Martin JN Jr, Morrison JC. Acute tocolysis for fetal distress: terbutaline versus magnesium sulphate. Aust N Z J Obstet Gynaecol. 1993 Nov;33(4):362-4. doi: 10.1111/j.1479-828x.1993.tb02109.x.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2017
• Primary Completion (Actual): September 15, 2019
• Study Completion (Actual): September 15, 2019

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: cesarean section; fetal resuscitation; acute tocolysis; fetal distress
• Additional Relevant MeSH Terms: Fetal Distress; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Sympathomimetics; Terbutaline
• Other Study ID Numbers: NMRR-16-1985-331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No