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Completed

NCT Number: NCT05326269

Acute Tocolysis With Terbutaline for Suspected Fetal Distress

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Kemaman

Kuala Terengganu, Terengganu, 24000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Terbutaline

Drug

Subcutaneous injection

Other names: beta mimetic

Primary outcomes

  1. Neonatal acidosis

    Time frame: within 1 hour of delivery

    Umbilical artery acidosis

Secondary outcomes

  1. Neonatal acid base status

    Time frame: within 1 hour of delivery

    Mean umbilical artery pH & base excess

  2. Neonatal Apgar score

    Time frame: 5 minutes after delivery

    Mean Apgar score at 5 minutes of life

  3. Neonatal intensive care unit admission

    Time frame: Within 24 hours of delivery

    Number of babies admitted to neonatal intensive care unit

  4. Maternal blood pressure

    Time frame: Within 1 hours after drug administration

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

  5. Maternal heart rate

    Time frame: Within 1 hours after drug administration

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

  6. Blood loss

    Time frame: Within 24 hours of delivery

    Mean estimated blood loss

  7. Hematocrit change

    Time frame: Within 24 hours of delivery

    Mean hematocrit changes before and after cesarean section

Sponsors and collaborators

Lead sponsor

Hospital Kemaman

Other

Registry information

Official study title

Acute Tocolysis With Terbutaline vs Placebo Prior to Emergency Caesarean Delivery for Suspected Intrauterine Fetal Compromise

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2022
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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