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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atosiban | Intravenous Atosiban as main tocolytic agent |
| |
| Terbutaline | Intravenous Terbutaline as main tocolytic agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term fetal repercussions | Fetal heart rate in the immediate postoperative period | In the end of the surgery, before extubation |
| Long-term fetal repercussions | Gestational age at birth |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who underwent intrauterine myelomeningocele surgical repair in a tertiary obstetrical center (Hospital das ClÃnicas da Faculdade de Medicina da Universidade de São Paulo), from November of 2017 to January of 2020.
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| Name | Affiliation | Role |
|---|---|---|
| Elaine I Moura, MD | Hospital das Clinicas | Principal Investigator |
| Hermann S Fernandes, PhD | Hospital das Clinicas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculdade de Medicina da Universidade de São Paulo | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23508219 | Result | 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. | |
| 18481813 | 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. |
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The IPD sharing plan includes informations about the demographic sample, the results of the study and the statistical analysis
From October/2017 until January/2021
Contact through email
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| ID | Term |
|---|---|
| D008591 | Meningomyelocele |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| C047046 | atosiban |
| D013726 | Terbutaline |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 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. |
|
| At the birth |
| 18417993 | 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. |
| 21306277 | 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. |
| 11605920 | 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. |
| 11892506 | 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. |
| 28547209 | 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. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000588 |
| Amines |