Neonatal Acid-Base Status After C Section With Maternal Tilt vs. Supine
Completed · Not applicable
Conditions studied: Aortocaval Compression, Fetal Acidosis
In brief
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 anesthesia, with systolic BP maintained at baseline with a phenylephrine (PE) infusion. The null hypothesis is that the position of the patient (supine horizontal or tilted) during cesarean section will make no difference to neonatal wellbeing. The primary outcome will be the neonatal umbilical arterial base deficit (BD) at birth. The investigators will also examine the effects of maternal position during cesarean section under spinal anesthesia on maternal cardiac output (CO) and whether these changes have a correlation with the neonatal umbilical cord blood acid-base status. The secondary outcome will be the total phenylephrine dose requirement at 15 minutes after spinal injection.
Key facts
- Study ID
- NCT02243423
- Run by
- Columbia University
- People needed
- 100
- Starts
- 2014-10-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2016-01-26
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- New York Presbyterian, Allen Hospital — New York, New York, United States
Full record on ClinicalTrials.gov
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