In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline

NCT04468568 | Completed

• 1 other identifier: 00607219.4.0030.0099
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Short-term fetal repercussions

  In the end of the surgery, before extubation

• Long-term fetal repercussions

  At the birth

Study Arms (2)

Atosiban

Intravenous Atosiban as main tocolytic agent

Drug: Atosiban

Terbutaline

Intravenous Terbutaline as main tocolytic agent

Drug: Terbutaline

Interventions

Atosiban 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.

Atosiban

Terbutaline 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.

Terbutaline

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Pregnant women over 18 years
• Single fetus pregnancy
• Fetus with myelomeningocele
• Gestational age from 19 to 26
• Fetus with normal karyotype

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

Location

Related Publications (7)

• 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.

  PMID: 23508219 RESULT

• Boulet SL, Yang Q, Mai C, Kirby RS, Collins JS, Robbins JM, Meyer R, Canfield MA, Mulinare J; National Birth Defects Prevention Network. Trends in the postfortification prevalence of spina bifida and anencephaly in the United States. Birth Defects Res A Clin Mol Teratol. 2008 Jul;82(7):527-32. doi: 10.1002/bdra.20468.

  PMID: 18481813 RESULT

• Fichter MA, Dornseifer U, Henke J, Schneider KT, Kovacs L, Biemer E, Bruner J, Adzick NS, Harrison MR, Papadopulos NA. Fetal spina bifida repair--current trends and prospects of intrauterine neurosurgery. Fetal Diagn Ther. 2008;23(4):271-86. doi: 10.1159/000123614. Epub 2008 Apr 14.

  PMID: 18417993 RESULT

• Adzick NS, Thom EA, Spong CY, Brock JW 3rd, Burrows PK, Johnson MP, Howell LJ, Farrell JA, Dabrowiak ME, Sutton LN, Gupta N, Tulipan NB, D'Alton ME, Farmer DL; MOMS Investigators. A randomized trial of prenatal versus postnatal repair of myelomeningocele. N Engl J Med. 2011 Mar 17;364(11):993-1004. doi: 10.1056/NEJMoa1014379. Epub 2011 Feb 9.

  PMID: 21306277 RESULT

• Fisk NM, Gitau R, Teixeira JM, Giannakoulopoulos X, Cameron AD, Glover VA. Effect of direct fetal opioid analgesia on fetal hormonal and hemodynamic stress response to intrauterine needling. Anesthesiology. 2001 Oct;95(4):828-35. doi: 10.1097/00000542-200110000-00008.

  PMID: 11605920 RESULT

• Cauldwell CB. Anesthesia for fetal surgery. Anesthesiol Clin North Am. 2002 Mar;20(1):211-26. doi: 10.1016/s0889-8537(03)00062-2.

  PMID: 11892506 RESULT

• 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.

  PMID: 28547209 RESULT

MeSH Terms

Conditions

Meningomyelocele

Interventions

atosiban; Terbutaline

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Elaine I Moura, MD

  Hospital das Clinicas

  PRINCIPAL INVESTIGATOR

• Hermann S Fernandes, PhD

  Hospital das Clinicas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthetist

Study Record Dates

• First Submitted: March 1, 2020
• First Posted: July 13, 2020
• Study Start: October 1, 2017
• Primary Completion: January 31, 2020
• Study Completion: April 1, 2022
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From October/2017 until January/2021
• Access Criteria: Contact through email

Locations

BR (1)