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In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline

NCT04468568 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2022-06-06

No results posted yet for this study

Summary

Myelomeningocele is a malformation with high incidence, and it consists in a neural tube defect. Fetal intrauterine surgery is an alternative for correction, and it improves the prognosis of the fetus, but has an increased risk of maternal complications and premature labor, as it can occur due to uterine stimulation. It is therefore essential that tocolysis is performed before, during and after surgery, and the most commonly used tocolytics are terbutaline and atosiban. Terbutaline has no specificity and may have several adverse effects such as maternal acidosis.

Conditions

  • Myelomeningocele
  • Terbutaline Adverse Reaction
  • Pregnancy; Malformation Central Nervous System

Interventions

DRUG

Atosiban

Atosiban intravenous. Dose: attack of 6.75 mg, and maintenance of 300 mcg / min for 3 hours, and 100 mcg / min for 21 hours.

DRUG

Terbutaline

Terbutaline intravenous. Dose: 2.5 mg in 500 mL saline, infusion rate of 30 mL / hr (150 mcg / h) during the surgery and for 24 hours.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Elaine I Moura, MD · Hospital das Clinicas

  • Hermann S Fernandes, PhD · Hospital das Clinicas

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2020-01-31
Completion
2022-04-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04468568 on ClinicalTrials.gov