In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2022-04-01

Brief Summary

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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.

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Detailed Description

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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

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Myelomeningocele Terbutaline Adverse Reaction Pregnancy; Malformation Central Nervous System

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Atosiban

Intravenous Atosiban as main tocolytic agent

Atosiban

Intervention Type DRUG

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

Terbutaline

Intravenous Terbutaline as main tocolytic agent

Terbutaline

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes