Acute Tocolysis With Terbutaline for Suspected Fetal Distress

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-23

Study Completion Date

2019-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement

NCT01651962

Labor Pain

UNKNOWN PHASE4

The Role of ARTificial Uterine CONtractions in Perinatal Respiratory Morbidity of Term Infants Delivered by Elective Caesarean Section

NCT03899597

Neonatal Respiratory Distress

NOT_YET_RECRUITING NA

Omission of Controlled Cord Traction During Active Management of Third Stage of Labor

NCT02656108

Labor Stage, Third

UNKNOWN NA

Intraumbilical Oxytocin Versus Placental Cord Drainage in the Management of 3rd Stage of Labor

NCT03395730

Postpartum Haemorrhage With Retained Placenta

UNKNOWN PHASE2

Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation

NCT00185887

Fetal Distress

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nonreassuring Fetal Status

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

Terbutaline 0.5 mls (0.25 mg) , subcutaneously

Group Type ACTIVE_COMPARATOR

Terbutaline

Intervention Type DRUG

Subcutaneous injection

Control group

Placebo (normal saline) 0.5 mls , subcutaneously

Group Type PLACEBO_COMPARATOR

Terbutaline

Intervention Type DRUG

Subcutaneous injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Terbutaline

Subcutaneous injection

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

beta mimetic

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes