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

January 22, 2016 updated by: Richard M. Smiley, Columbia University

Neonatal Acid-base Status After Elective Cesarean Delivery Under Spinal Anesthesia - a Comparison of Maternal Supine Horizontal Position Versus Left Lateral Table Tilt

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 weeks gestation) with singleton pregnancies in cephalic presentation, scheduled for elective cesarean delivery under spinal anesthesia. Patients will receive spinal anesthesia for cesarean section in the sitting position, after which they will lay either supine horizontal or the surgical table will be tilted to the left by 15°, depending on the group to which they were randomized (SUPINE or TILT). An IV phenylephrine infusion will be administered to maintain systolic BP at baseline until delivery. A noninvasive hemodynamic monitoring system (NICOM, Cheetah Medical Inc., Vancouver, WA, USA) will continuously monitor CO and stroke volume. Neonatal umbilical vein and arterial blood gas results will be recorded.The null hypothesis is that the position of the patient (supine horizontal or tilted) during cesarean section will make no difference to neonatal wellbeing.

Statistical Design: The estimated sample size is the minimum number of study subjects required for rejecting the alternative hypothesis (i.e., accepting the null hypothesis). A significant difference between groups in the primary outcome, umbilical artery BD (which is a measure of fetal well being at the time of delivery and an indirect indicator of the adequacy of uteroplacental perfusion) would be of the order of magnitude of 2 mmol/L. Standard deviation of BD tends to be of this magnitude also. It would therefore require 22 subjects per group for 90% power to detect this magnitude of difference with alpha 0.05. Because BD is often not normally distributed, it is appropriate to increase sample size by 10-20%, and because the investigators have important secondary outcomes (PE usage, UA and UV pH, UV BD) the investigators intend to recruit 50 subjects per group to allow sufficient power for analysis of these secondary outcomes with appropriate correction for multiple comparisons, and allowing for 10% dropout. PE usage in the investigators previous study tends to have a standard deviation of about 30% of the mean, also roughly the magnitude of a clinically significant difference.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10034
        • New York Presbyterian, Allen Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SUPINE group
The surgical table will remain horizontal after intrathecal (spinal) anesthesia injection for cesarean section. Choosing to position the patient supine is the intervention.
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.
Active Comparator: TILT group
The surgical table will be turned to 15° of left lateral tilt after patients are laid supine after spinal anesthesia injection. The tilted group is the control group.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Base deficit (umbilical artery) (mEq/L)
Time Frame: Within 2 hours of birth
The primary outcome will be the neonatal umbilical arterial base deficit at birth.Neonatal umbilical vein and arterial blood gas results (these are routinely sent by the obstetric service at Columbia University Medical Center for all deliveries)
Within 2 hours of birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total phenylephrine dose (mg)
Time Frame: 15 minutes after spinal injection
The secondary outcome will be the total phenylephrine dose requirement at 15 minutes after spinal injection. The phenylephrine (PE) infusion will be titrated to maintain the systolic arterial pressure (SBP) at baseline. If the SBP is at or above baseline, no PE will be administered. If SBP is 90-99% of baseline, PE infusion will be at 50 μg/min. If the SBP is 80-89% of baseline, PE will be 100 μg/min. If SBP is less than 80% of baseline, the infusion will be doubled to 200 μg/min. When SBP returns to more than 90% of baseline, the infusion will be returned to 50 μg/min. If the SBP remains < 80% of baseline after 1 minute at 200 μg/min, additional boluses of IV phenylephrine 80 μg may be given. If this regimen is unsuccessful at restoring SBP to >90% of baseline within 3 minutes, any other indicated maneuver may be used.
15 minutes after spinal injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Richard Smiley, MD, PhD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

September 6, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (Estimate)

September 18, 2014

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAO1851

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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