Clinical trial NCT04468568: In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline
Official title: Assessment of Maternal Blood Gas Changes When Using Atosiban and Terbutaline as Tocolytic Agents, During in Utero Repair of Myelomeningocele
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelomeningocele
Terbutaline Adverse Reaction
Pregnancy; Malformation Central Nervous System
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent intrauterine myelomeningocele surgical repair in a tertiary obstetrical center (Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo), from November of 2017 to January of 2020.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Maternal arterial blood pH at the start of surgery
timeFrame: Right after intubation
measure: Maternal arterial blood pH at the end of surgery
timeFrame: Before extubation
measure: Maternal arterial blood pH at 120 minutes after surgery
timeFrame: Two hours after the end of surgery
Secondary outcomes:
measure: Short-term fetal repercussions
timeFrame: In the end of the surgery, before extubation
measure: Long-term fetal repercussions
timeFrame: At the birth
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: Hospital das Clinicas
name: Elaine I Moura, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital das Clinicas
name: Hermann S Fernandes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferschl M, Ball R, Lee H, Rollins MD. Anesthesia for in utero repair of myelomeningocele. Anesthesiology. 2013 May;118(5):1211-23. doi: 10.1097/ALN.0b013e31828ea597.
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citation: Devoto JC, Alcalde JL, Otayza F, Sepulveda W. Anesthesia for myelomeningocele surgery in fetus. Childs Nerv Syst. 2017 Jul;33(7):1169-1175. doi: 10.1007/s00381-017-3437-7. Epub 2017 May 25.