In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline

Completed

• Conditions: Myelomeningocele; Terbutaline Adverse Reaction; Pregnancy; Malformation Central Nervous System
• Interventions: Drug: Atosiban; Drug: Terbutaline

• Registration Number: NCT04468568
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

Study Timeline

• Study Start: 2017-10-01
• Primary Completion: 2020-01-31
• Study First Submitted: 2020-03-01
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-13
• Study Completion: 2022-04-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• Pregnant women over 18 years
• Single fetus pregnancy
• Fetus with myelomeningocele
• Gestational age from 19 to 26
• Fetus with normal karyotype

Exclusion Criteria

• Multiple pregnancy
• Fetal abnormality not related to myelomeningocele
• Kyphosis greater than or equal to 30 degrees
• Placenta previa
• Maternal disease that increases the risk of pregnancy (insulin-dependent DM, hypertension poorly controlled)
• History of incompetent cervix
• Carrier of HIV, hepatitis B or hepatitis C
• Maternal-fetal isoimmunization
• Uterine Alteration
• Obesity (IMC greater than 30)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atosiban	Atosiban	Intravenous Atosiban as main tocolytic agent
Terbutaline	Terbutaline	Intravenous Terbutaline as main tocolytic agent

Primary Outcome Measures

Name	Time	Method
Maternal arterial blood pH at the start of surgery	Right after intubation	Arterial blood pH
Maternal arterial blood pH at the end of surgery	Before extubation	Arterial blood pH
Maternal arterial blood pH at 120 minutes after surgery	Two hours after the end of surgery	Arterial blood pH

Secondary Outcome Measures

Name	Time	Method
Short-term fetal repercussions	In the end of the surgery, before extubation	Fetal heart rate in the immediate postoperative period
Long-term fetal repercussions	At the birth	Gestational age at birth

Trial Locations

Locations (1)

Faculdade de Medicina da Universidade de São Paulo; 🇧🇷 São Paulo, Brazil