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
Verified date | June 2022 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Brazil | Faculdade de Medicina da Universidade de São Paulo | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
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
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 |
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