CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Atosiban +1 moredrug
Likely dose
Atosiban 6.75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04468568
NCT04468568N/ACompleted

Assessment of Maternal Blood Gas Changes When Using Atosiban and Terbutaline as Tocolytic Agents, During in Utero Repair of Myelomeningocele

University of Sao Paulo General Hospital·observational·Posted Jul 13, 2020·Updated Jun 6, 2022

In Brief

An observational study evaluating Atosiban and Terbutaline for Myelomeningocele and 2 related conditions. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 13, 2020
Enrollment StartOct 1, 2017
Primary CompletionJan 31, 2020
Study CompletionApr 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.0 years ago

Interventions

Atosibandrug

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

Terbutalinedrug

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.