In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline

Study Overview
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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.

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.

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

Conditions
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Myelomeningocele, Terbutaline Adverse Reaction, Pregnancy; Malformation Central Nervous System

Intervention / Treatment
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* Drug: Atosiban
* Drug: Terbutaline


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atosiban<br>Intravenous Atosiban as main tocolytic agent | Drug: Atosiban<br>* Atosiban intravenous. Dose: attack of 6.75 mg, and maintenance of 300 mcg / min for 3 hours, and 100 mcg / min for 21 hours.<br>|
| Terbutaline<br>Intravenous Terbutaline as main tocolytic agent | Drug: Terbutaline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal arterial blood pH at the start of surgery | Arterial blood pH | Right after intubation | 
| Maternal arterial blood pH at the end of surgery | Arterial blood pH | Before extubation | 
| Maternal arterial blood pH at 120 minutes after surgery | Arterial blood pH | Two hours after the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term fetal repercussions | Fetal heart rate in the immediate postoperative period | In the end of the surgery, before extubation | 
| Long-term fetal repercussions | Gestational age at birth | At the birth |