Status:
COMPLETED
Neonatal Acid-Base Status After C Section With Maternal Tilt vs. Supine
Lead Sponsor:
Columbia University
Conditions:
Aortocaval Compression
Fetal Acidosis
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
This study aims to compare the neonatal acid-base status of women who remain supine horizontal, with women who are tilted to the left side by 15° during elective cesarean delivery at term under spinal...
Detailed Description
Methods: This will be a randomized trial structured as an equivalence trial. Subjects will be American Society of Anesthesiologists (ASA) I and II women aged ≥18 years, non-laboring, at term (\>37 wee...
Eligibility Criteria
Inclusion
- ASA I and II women aged ≥18 years
- Non-laboring
- At term (\>37 weeks gestation) with singleton pregnancies in cephalic presentation
- Scheduled for elective cesarean delivery under spinal anesthesia.
- Maternal height will be between 150 - 180 cm and the body mass index (BMI)≤ 40 kg/m2.
Exclusion
- Ruptured membranes
- Severe polyhydramnios or oligohydramnios
- Nonreassuring fetal heart rate
- Intrauterine growth restriction
- Abnormal lie - e.g. breech, transverse lie
- Multiple gestation
- Maternal comorbidities: hypertension, preeclampsia, other cardiovascular disease, renal failure, diabetes mellitus\> 10 years, severe scoliosis or kyphosis, uterine abnormalities (e.g. large fibroids, bicornuate uterus)
- Medications - anti-hypertensive agents
- Current smoking or illicit drug use
- Failed spinal (sensory level \< T6 after 15 minutes), need to convert to general anesthesia before delivery (exclusion from data analysis
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02243423
Start Date
October 1 2014
End Date
January 1 2016
Last Update
January 26 2016
Active Locations (1)
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1
New York Presbyterian, Allen Hospital
New York, New York, United States, 10034