AzTrials
AzTrials

MyelomeningoceleNCT04468568

In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline

An observational study of Myelomeningocele and Terbutaline Adverse Reaction, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
What is being tested?
Atosiban and Terbutaline
Type of treatment
Injection or infusion
How many people
25 participants
Where
1 siteBrazil
Study dates
1 Oct 2017to 1 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • Carrier of HIV, hepatitis B or hepatitis C
  • Maternal-fetal isoimmunization
  • Uterine Alteration
  • Obesity (IMC greater than 30)

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Faculdade de Medicina da Universidade de São Paulo

    São Paulo

Other trials in Brazil

About this study

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

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.

Read the 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.

Being tested
Atosiban, Terbutaline
Medical subject headings
Meningomyelocele

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtosibanDrug

    Atosiban intravenous. Dose: attack of 6.75 mg, and maintenance of 300 mcg / min for 3 hours, and 100 mcg / min for 21 hours.

  • TerbutalineDrug

    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 in NCT04468568
Study groupRoleWhat they receive
AtosibanIntravenous Atosiban as main tocolytic agent
Receives: Drug: Atosiban
TerbutalineIntravenous Terbutaline as main tocolytic agent
Receives: Drug: Terbutaline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal arterial blood pH at the start of surgery

    Arterial blood pH

    Measured: Right after intubation

  2. Maternal arterial blood pH at the end of surgery

    Arterial blood pH

    Measured: Before extubation

  3. Maternal arterial blood pH at 120 minutes after surgery

    Arterial blood pH

    Measured: Two hours after the end of surgery

Secondary outcomes (2)

  1. Short-term fetal repercussions

    Fetal heart rate in the immediate postoperative period

    Measured: In the end of the surgery, before extubation

  2. Long-term fetal repercussions

    Gestational age at birth

    Measured: At the birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2020
  2. Study start1 Oct 2017
  3. Primary completion31 Jan 2020
  4. Study completion1 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04468568
Sponsor's protocol ID
00607219.4.0030.0099
Status last verified
Jun 2022
First submitted
1 Mar 2020
Last updated
6 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The IPD sharing plan includes informations about the demographic sample, the results of the study and the statistical analysis

Publications

  • 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.

    PubMed 23508219

  • 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.

    PubMed 18481813

  • 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.

    PubMed 18417993

  • 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.

    PubMed 21306277

  • 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.

    PubMed 11605920

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

    PubMed 11892506

  • 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.

    PubMed 28547209

  • Andrade Santos S, Souza Nani F, Imaeda de Moura E, Lima de Carvalho D, Jorge Mattos Miguel G, Maria Federicci Haddad C, Edson Vieira J, Bunduki V, Henrique Burlacchini de Carvalho M, Pulcineli Vieira Francisco R, Dante Cardeal D, Dos Santos Fernandes H. Comparison of terbutaline and atosiban as tocolytic agents in intrauterine repair of myelomeningocele: a retrospective cohort study. Braz J Anesthesiol. 2024 May-Jun;74(3):844495. doi: 10.1016/j.bjane.2024.844495. Epub 2024 Mar 22.

    PubMed 38521500

Questions about this trial

What is this clinical trial studying?

An observational study of Myelomeningocele and Terbutaline Adverse Reaction, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal arterial blood pH at the start of surgery (time frame: Right after intubation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04468568, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in