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Acute Tocolysis With Terbutaline for Suspected Fetal Distress

Primary Purpose

Nonreassuring Fetal Status

Status

Completed

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

Terbutaline

About this trial

This is an interventional treatment trial for Nonreassuring Fetal Status focused on measuring fetal resuscitation, acute tocolysis, fetal distress, cesarean section

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

Hospital Kemaman

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

Terbutaline 0.5 mls (0.25 mg) , subcutaneously

Placebo (normal saline) 0.5 mls , subcutaneously

Outcomes

Primary Outcome Measures

Neonatal acidosis

Umbilical artery acidosis

Secondary Outcome Measures

Neonatal acid base status

Mean umbilical artery pH & base excess

Neonatal Apgar score

Mean Apgar score at 5 minutes of life

Neonatal intensive care unit admission

Number of babies admitted to neonatal intensive care unit

Maternal blood pressure

Mean maternal arterial pressure (before and after drug or placebo administration)

Maternal heart rate

Mean maternal heart rate changes (before and after drug or placebo administration)

Blood loss

Mean estimated blood loss

Hematocrit change

Mean hematocrit changes before and after cesarean section

Full Information

NCT ID

NCT05326269

First Posted

March 22, 2022

Last Updated

April 5, 2022

Sponsor

Hospital Kemaman

1. Study Identification

Unique Protocol Identification Number

NCT05326269

Brief Title

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

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

April 23, 2017 (Actual)

Primary Completion Date

September 15, 2019 (Actual)

Study Completion Date

September 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Kemaman

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nonreassuring Fetal Status

Keywords

fetal resuscitation, acute tocolysis, fetal distress, cesarean section

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Masking Description

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

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Active Comparator

Arm Description

Terbutaline 0.5 mls (0.25 mg) , subcutaneously

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Placebo (normal saline) 0.5 mls , subcutaneously

Intervention Type

Drug

Intervention Name(s)

Terbutaline

Other Intervention Name(s)

beta mimetic

Intervention Description

Subcutaneous injection

Primary Outcome Measure Information:

Title

Neonatal acidosis

Description

Umbilical artery acidosis

Time Frame

within 1 hour of delivery

Secondary Outcome Measure Information:

Title

Neonatal acid base status

Description

Mean umbilical artery pH & base excess

Time Frame

within 1 hour of delivery

Title

Neonatal Apgar score

Description

Mean Apgar score at 5 minutes of life

Time Frame

5 minutes after delivery

Title

Neonatal intensive care unit admission

Description

Number of babies admitted to neonatal intensive care unit

Time Frame

Within 24 hours of delivery

Title

Maternal blood pressure

Description

Mean maternal arterial pressure (before and after drug or placebo administration)

Time Frame

Within 1 hours after drug administration

Title

Maternal heart rate

Description

Mean maternal heart rate changes (before and after drug or placebo administration)

Time Frame

Within 1 hours after drug administration

Title

Blood loss

Description

Mean estimated blood loss

Time Frame

Within 24 hours of delivery

Title

Hematocrit change

Description

Mean hematocrit changes before and after cesarean section

Time Frame

Within 24 hours of delivery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zahar A Zakaria, MD

Organizational Affiliation

Hospital Kemaman

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Kemaman

City

Kuala Terengganu

State/Province

Terengganu

ZIP/Postal Code

24000

Country

Malaysia

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Upon request

Citations:

PubMed Identifier

3303936

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.

Results Reference

background

PubMed Identifier

4073156

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.

Results Reference

background

PubMed Identifier

29971813

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.

Results Reference

background

PubMed Identifier

17904983

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.

Results Reference

background

PubMed Identifier

32378185

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.

Results Reference

result

PubMed Identifier

8179541

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.

Results Reference

result

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Acute Tocolysis With Terbutaline for Suspected Fetal Distress

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