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Neonatal Acid-Base Status After C Section With Maternal Tilt vs. Supine

NCT02243423 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-01-26

No results posted yet for this study

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 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.

Conditions

  • Aortocaval Compression
  • Fetal Acidosis

Interventions

PROCEDURE

SUPINE

Patients in the SUPINE group will receive spinal anesthesia for cesarean section in the sitting position, after which they will lay supine horizontal on the surgical table. A phenylephrine intravenous infusion will be titrated according to a set protocol, to maintain the systolic blood pressure at baseline.

PROCEDURE

TILT

Patients will receive spinal anesthesia for cesarean section in the sitting position, after which they will lay on the surgical table, which will be tilted to the left by 15°. A phenylephrine intravenous infusion will be titrated according to a set protocol to maintain the systolic blood pressure at baseline.

Sponsors & Collaborators

Principal Investigators

  • Richard Smiley, MD, PhD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02243423 on ClinicalTrials.gov