Acute Tocolysis With Terbutaline for Suspected Fetal Distress

NCT05326269 | Completed DMC

• 1 other identifier: NMRR-16-1985-331
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nonreassuring Fetal Status

Keywords

fetal resuscitation; acute tocolysis; fetal distress; cesarean section

Outcome Measures

Primary Outcomes (1)

• Neonatal acidosis

  Umbilical artery acidosis

  within 1 hour of delivery

Secondary Outcomes (7)

• Neonatal acid base status

  within 1 hour of delivery

• Neonatal Apgar score

  5 minutes after delivery

• Neonatal intensive care unit admission

  Within 24 hours of delivery

• Maternal blood pressure

  Within 1 hours after drug administration

• Maternal heart rate

  Within 1 hours after drug administration

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Terbutaline 0.5 mls (0.25 mg) , subcutaneously

Drug: Terbutaline

Control group

PLACEBO COMPARATOR

Placebo (normal saline) 0.5 mls , subcutaneously

Drug: Terbutaline

Interventions

Terbutaline DRUG

Subcutaneous injection

Also known as: beta mimetic

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Kemaman: lead

Study Sites (1)

Hospital Kemaman

Kuala Terengganu, Terengganu, 24000, Malaysia

Location

Related Publications (6)

• 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.

  PMID: 3303936 BACKGROUND

• 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.

  PMID: 4073156 BACKGROUND

• 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.

  PMID: 29971813 BACKGROUND

• 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.

  PMID: 17904983 BACKGROUND

• 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.

  PMID: 32378185 RESULT

• 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.

  PMID: 8179541 RESULT

MeSH Terms

Conditions

Fetal Distress

Interventions

Terbutaline

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Zahar A Zakaria, MD

  Hospital Kemaman

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Consultant Obstetrician

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 13, 2022
• Study Start: April 23, 2017
• Primary Completion: September 15, 2019
• Study Completion: September 15, 2019
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)