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In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04468568
Recruitment Status : Completed
First Posted : July 13, 2020
Last Update Posted : June 6, 2022
Sponsor:
Information provided by (Responsible Party):
Hermann dos Santos Fernandes, University of Sao Paulo General Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Myelomeningocele Terbutaline Adverse Reaction Pregnancy; Malformation Central Nervous System Drug: Atosiban Drug: Terbutaline

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 Design
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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessment of Maternal Blood Gas Changes When Using Atosiban and Terbutaline as Tocolytic Agents, During in Utero Repair of Myelomeningocele
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Atosiban
Intravenous Atosiban as main tocolytic agent
 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.
Terbutaline
Intravenous Terbutaline as main tocolytic agent
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Maternal arterial blood pH at the start of surgery [ Time Frame: Right after intubation ]
    Arterial blood pH

  2. Maternal arterial blood pH at the end of surgery [ Time Frame: Before extubation ]
    Arterial blood pH

  3. Maternal arterial blood pH at 120 minutes after surgery [ Time Frame: Two hours after the end of surgery ]
    Arterial blood pH


Secondary Outcome Measures :
  1. Short-term fetal repercussions [ Time Frame: In the end of the surgery, before extubation ]
    Fetal heart rate in the immediate postoperative period

  2. Long-term fetal repercussions [ Time Frame: At the birth ]
    Gestational age at birth


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04468568


Locations
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Brazil
Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Elaine I Moura, MD Hospital das Clinicas
Principal Investigator: Hermann S Fernandes, PhD Hospital das Clinicas
More Information
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Publications of Results:

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Responsible Party: Hermann dos Santos Fernandes, Attending Anesthetist, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04468568    
Other Study ID Numbers: 00607219.4.0030.0099
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The IPD sharing plan includes informations about the demographic sample, the results of the study and the statistical analysis
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: From October/2017 until January/2021
Access Criteria: Contact through email

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Meningomyelocele
Spina Bifida Cystica
Congenital Abnormalities
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Spinal Dysraphism
Terbutaline
Atosiban
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anti-Asthmatic Agents
Respiratory System Agents
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists