Acute Tocolysis With Terbutaline for Suspected Fetal Dist... | NCT05326269

Studies
Acute Tocolysis With Terbutaline for Suspected Fetal Distress

NCT05326269

Sponsor

Hospital Kemaman

Status

Completed

Last Update Posted

Apr 13, 2022Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Nonreassuring Fetal Status

Interventions

Terbutaline

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 23, 2017Actual

Primary Completion Date

Sep 15, 2019Actual

Completion Date

Sep 15, 2019Actual

First Submitted Date

Mar 22, 2022

First Submission Date that Met QC Criteria

Apr 5, 2022

First Posted Date

Apr 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2022

Last Update Posted Date

Apr 13, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zahar Azuar Zakaria, Principal investigator, Consultant Obstetrician, Hospital KemamanPrincipal Investigator

Lead Sponsor

Hospital KemamanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Terbutaline	Drug	Subcutaneous injection	Control group Intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neonatal acidosis	Umbilical artery acidosis	within 1 hour of delivery

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zahar A Zakaria, MD	Hospital Kemaman	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Kemaman		Kuala Terengganu	Terengganu	24000	Malaysia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
3303936	Background	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.
4073156	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.

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals