NCT04468568

In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

The objective of the study was to evaluate maternal blood gas alterations among cases that used atosiban tocolytic agent and cases with terbutaline in in utero repair of myelomeningocele. It consists of a retrospective cohort study. It included 25 patients, who were divided into two groups, depending on which agent they received as main tocolytic agent during the intrauterine fetal myelomeningocele repair: terbutalineor atosiban. The primary outcome was maternal arterial pH at the end of surgery.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-10-01
• Primary completion: 2020-01-31
• Completion: 2022-04-01
• First posted: 2020-07-13
• Last updated: 2022-06-06

Locations

1 site across 1 country: Brazil