In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline

Myelomeningocele Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04468568
• Other study ID #: 00607219.4.0030.0099
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: April 1, 2022

Study information

• Verified date: June 2022
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 1, 2022
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

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

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.
• 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.

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina da Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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. — View Citation

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 C — View Citation

Cauldwell CB. Anesthesia for fetal surgery. Anesthesiol Clin North Am. 2002 Mar;20(1):211-26. — View 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. Review. — View 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. — View Citation

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/ — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal arterial blood pH at the start of surgery	Arterial blood pH	Right after intubation
Primary	Maternal arterial blood pH at the end of surgery	Arterial blood pH	Before extubation
Primary	Maternal arterial blood pH at 120 minutes after surgery	Arterial blood pH	Two hours after the end of surgery
Secondary	Short-term fetal repercussions	Fetal heart rate in the immediate postoperative period	In the end of the surgery, before extubation
Secondary	Long-term fetal repercussions	Gestational age at birth	At the birth