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In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline

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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

Tracking Information
First Submitted Date March 1, 2020
First Posted Date July 13, 2020
Last Update Posted Date June 6, 2022
Actual Study Start Date October 1, 2017
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 10, 2020)
  • Maternal arterial blood pH at the start of surgery [ Time Frame: Right after intubation ]
    Arterial blood pH
  • Maternal arterial blood pH at the end of surgery [ Time Frame: Before extubation ]
    Arterial blood pH
  • Maternal arterial blood pH at 120 minutes after surgery [ Time Frame: Two hours after the end of surgery ]
    Arterial blood pH
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 10, 2020)
  • Short-term fetal repercussions [ Time Frame: In the end of the surgery, before extubation ]
    Fetal heart rate in the immediate postoperative period
  • Long-term fetal repercussions [ Time Frame: At the birth ]
    Gestational age at birth
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Myelomeningocele
  • Terbutaline Adverse Reaction
  • Pregnancy; Malformation Central Nervous System
Intervention
  • 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.
  • 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.
Study Groups/Cohorts
  • Atosiban
    Intravenous Atosiban as main tocolytic agent
    Intervention: Drug: Atosiban
  • Terbutaline
    Intravenous Terbutaline as main tocolytic agent
    Intervention: Drug: Terbutaline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 2, 2022)
25
Original Estimated Enrollment
 (submitted: July 10, 2020)
28
Actual Study Completion Date April 1, 2022
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT04468568
Other Study ID Numbers 00607219.4.0030.0099
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: From October/2017 until January/2021
Access Criteria: Contact through email
Current Responsible Party Hermann dos Santos Fernandes, University of Sao Paulo General Hospital
Original Responsible Party Same as current
Current Study Sponsor University of Sao Paulo General Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Elaine I Moura, MD Hospital das Clinicas
Principal Investigator: Hermann S Fernandes, PhD Hospital das Clinicas
PRS Account University of Sao Paulo General Hospital
Verification Date June 2022