Myelomeningocele, Pregnancy; Malformation Central Nervous System, Terbutaline Adverse Reaction
Conditions
Brief 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.
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
DRUGAtosiban
Atosiban intravenous. Dose: attack of 6.75 mg, and maintenance of 300 mcg / min for 3 hours, and 100 mcg / min for 21 hours.
DRUGTerbutaline
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.
Sponsors
University of Sao Paulo General Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal arterial blood pH at the start of surgery | Right after intubation | Arterial blood pH |
| Maternal arterial blood pH at the end of surgery | Before extubation | Arterial blood pH |
| Maternal arterial blood pH at 120 minutes after surgery | Two hours after the end of surgery | Arterial blood pH |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-term fetal repercussions | In the end of the surgery, before extubation | Fetal heart rate in the immediate postoperative period |
| Long-term fetal repercussions | At the birth | Gestational age at birth |
Countries
Brazil
Outcome results
None listed