Acute Tocolysis With Terbutaline for Suspected Fetal Distress

Hospital Kemaman

Status: Completed

Conditions: Nonreassuring Fetal Status

Treatments: Drug: Terbutaline

Study type: Interventional

Funder types: Other

Identifiers

NCT05326269

NMRR-16-1985-331

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Intervention group

Active Comparator group

Description:

Terbutaline 0.5 mls (0.25 mg) , subcutaneously

Treatment:

Drug: Terbutaline

Control group

Placebo Comparator group

Description:

Placebo (normal saline) 0.5 mls , subcutaneously

Treatment:

Drug: Terbutaline