Acute Tocolysis With Terbutaline for Suspected Fetal Distress

Nonreassuring Fetal Status Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05326269
• Other study ID #: NMRR-16-1985-331
• Status: Completed
• Phase: N/A
• Start date: April 23, 2017
• Est. completion date: September 15, 2019

Study information

• Verified date: April 2022
• Source: Hospital Kemaman
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 15, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Fetal Distress
• Nonreassuring Fetal Status

Intervention

Drug:
• Terbutaline
Subcutaneous injection

Locations

Country	Name	City	State
Malaysia	Hospital Kemaman	Kuala Terengganu	Terengganu

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Kemaman

Country where clinical trial is conducted

Malaysia, 

References & Publications (6)

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. — View Citation

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. — View Citation

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:CD009770. doi: 10.1002/14651858.CD009770.pub2. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal acidosis	Umbilical artery acidosis	within 1 hour of delivery
Secondary	Neonatal acid base status	Mean umbilical artery pH & base excess	within 1 hour of delivery
Secondary	Neonatal Apgar score	Mean Apgar score at 5 minutes of life	5 minutes after delivery
Secondary	Neonatal intensive care unit admission	Number of babies admitted to neonatal intensive care unit	Within 24 hours of delivery
Secondary	Maternal blood pressure	Mean maternal arterial pressure (before and after drug or placebo administration)	Within 1 hours after drug administration
Secondary	Maternal heart rate	Mean maternal heart rate changes (before and after drug or placebo administration)	Within 1 hours after drug administration
Secondary	Blood loss	Mean estimated blood loss	Within 24 hours of delivery
Secondary	Hematocrit change	Mean hematocrit changes before and after cesarean section	Within 24 hours of delivery