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.
In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline
Status
Completed
Phase
Not applicable
Enrollment
25
Locations
1
Results
Not posted
Publications
7
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
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.
Timeline
From registration to results.
First posted
Jul 13, 2020
Study start
Oct 1, 2017
Primary completion
Jan 31, 2020
Study completion
Apr 1, 2022
Results posted
Not reported
Registry updated
Jun 6, 2022
Outcomes
What the study measures.
Primary outcomes
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
Secondary outcomes
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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 40 Years
- Sex
- FEMALE
- Healthy volunteers
- Yes
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)
Study locations
1 registered sites.
Brazil. Showing up to 24 locations stored in the fast local snapshot.
Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil
Publications
Results and literature.
PMID 23508219 ↗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 18481813 ↗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 18417993 ↗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 21306277 ↗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 11605920 ↗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 11892506 ↗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 28547209 ↗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.
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