Clinical trial NCT05326269: Acute Tocolysis With Terbutaline for Suspected Fetal Distress
Official title: Acute Tocolysis With Terbutaline vs Placebo Prior to Emergency Caesarean Delivery for Suspected Intrauterine Fetal Compromise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonreassuring Fetal Status
Keywords: fetal resuscitation
acute tocolysis
fetal distress
cesarean section
Lead sponsor: Hospital Kemaman
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Neonatal acidosis
timeFrame: within 1 hour of delivery
Secondary outcomes:
measure: Neonatal acid base status
timeFrame: within 1 hour of delivery
measure: Neonatal Apgar score
timeFrame: 5 minutes after delivery
measure: Neonatal intensive care unit admission
timeFrame: Within 24 hours of delivery
measure: Maternal blood pressure
timeFrame: Within 1 hours after drug administration
measure: Maternal heart rate
timeFrame: Within 1 hours after drug administration
measure: Blood loss
timeFrame: Within 24 hours of delivery
measure: Hematocrit change
timeFrame: Within 24 hours of delivery
Other outcomes:
Locations:
city: Kuala Terengganu
country: Malaysia
facility: Hospital Kemaman
state: Terengganu
Study officials:
affiliation: Hospital Kemaman
name: Zahar A Zakaria, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s0002-9378(87)80178-3.
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. doi: 10.1016/0002-9378(85)90690-8.
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(7):CD009770. doi: 10.1002/14651858.CD009770.pub2.
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. doi: 10.1016/j.ajog.2007.06.063.
citation: 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.
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. doi: 10.1111/j.1479-828x.1993.tb02109.x.