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CompletedNCT03455660Updated Mar 6, 2018

A Retrospective Comparison of Neonatal Acid-base Status After CD Before January, 2015 and After January, 2016

An observational study in Cesarean Delivery, sponsored by Columbia University. Completed at 1 site in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-06.

Sponsored by Columbia University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
101
Ages
18 Years to 55 Years
Sex
Female
01

Study summary

The objective is to retrospectively gather peri-operative data on neonatal outcomes, primarily neonatal acid-base status, based on umbilical cord gas analysis, for the 23 months preceding and 23 months following the conduct of the "tilt versus supine study". The investigators hypothesize that there will be no difference in mean neonatal umbilical artery base excess in neonates delivered by cesarean section during the period before and after conduct of the study, for elective, urgent and emergent deliveries.

Read the detailed description

For decades, obstetric anesthesia dogma for term women undergoing cesarean delivery (CD) includes maintenance of left lateral tilt for uterine displacement until delivery, based on the premise that the supine position will result in aortocaval compression (ACC), maternal hypotension and fetal compromise. More recent evidence suggests that even in 15 degrees of left tilt, there is minimal relief of aortocaval compression. Furthermore, there is evidence that most practitioners never achieve 15 degrees of tilt anyway.

Between January 2015 and January 2016, the investigators conducted a randomized clinical trial at NewYork Presbyterian/The Allen Hospital in which healthy women undergoing elective CD were randomized (non-blinded) to supine horizontal (SUPINE, N=50) or 15° left tilt of the surgical table (TILT, N= 50) following spinal anesthesia (hyperbaric bupivacaine 12 mg, fentanyl 15 μg, preservative-free morphine 150 μg). Lactated Ringer's 10ml/kg and a phenylephrine (PE) infusion titrated to 100% baseline systolic blood pressure (SBP) were initiated with intrathecal injection. The primary outcome was umbilical artery base excess (UA-BE). There were no differences in UA-BE or pH between groups. The mean UA-BE (± SD) was -0.5 mmol/L (± 1.6) in the SUPINE group (n=50) versus -0.6 mmol/L (± 1.5) in the TILT group (n=47) (p= 0.64). The conclusion was that maternal supine position during elective CD with spinal anesthesia in healthy term women does not impair neonatal acid-base status compared to 15° left tilt, when maternal SBP is maintained with a coload and PE infusion. The investigators understood that the findings may not be generalized to emergency situations or non-reassuring fetal status.

Since the end of the study, discussion of the findings with colleagues at Departmental grand rounds and national conferences, and a publication in the journal Anesthesiology, practitioners have reported feeling more comfortable with maternal supine position during cesarean delivery, as long as maternal SBP is kept at or near to baseline with crystalloid infusion and a PE infusion. It is routine practice at CUMC to use a prophylactic PE infusion for maintenance of maternal SBP close to or at baseline. It is also routine at CUMC to send samples of umbilical arterial and venous blood for analysis. Much of the dosing for neuraxial anesthesia (spinal, combined spinal epidural anesthesia and epidural doses) are standardized at CUMC. The investigators believe that since there has been a noticeable practice shift with practitioners anecdotally reporting that they have discontinued the routine use of left maternal tilt intraoperatively, the investigators will be able to collect useful data on cases which had not been studied - these include cases with preeclampsia, morbid obesity and emergencies.

02

Conditions studied

  • Cesarean Delivery

Keywords

  • Cesarean
  • C-Section
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Retrospective cohorts of women who delivered between February 2013 and December 2014, and between February 2016 and December 2017

Inclusion criteria

  • Women who delivered between February 2013 and December 2014, and between February 2016 and December 2017

Exclusion criteria

Exclusion Criteria:

  • none
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
101 participants (actual)
Patient registry
No

Groups and cohorts

  • Pre-January 2015

    Patients who underwent cesarean delivery between February 2013 and December 2014.

    Other: no intervention

  • Post-January 2016

    Patients who underwent cesarean delivery between February 2016 and December 2017.

    Other: no intervention

Interventions

  • Otherno intervention

    no intervention

05

What researchers measure

Primary outcomes

  1. Umbilical artery base excess

    Base excess calculation of umbilical artery blood

    Time frame: 10 minutes

Secondary outcomes

  1. Umbilical artery pH

    pH measurement of umbilical artery blood

    Time frame: 10 minutes

06

Study locations

1 site
  • NewYork Presbyterian/The Allen Hospital
    New York, New York 10034, United States
07

References and documents

Publications

  • Lee AJ, Landau R. Aortocaval Compression Syndrome: Time to Revisit Certain Dogmas. Anesth Analg. 2017 Dec;125(6):1975-1985. doi: 10.1213/ANE.0000000000002313. PubMed 28759487 ↗
  • Higuchi H, Takagi S, Zhang K, Furui I, Ozaki M. Effect of lateral tilt angle on the volume of the abdominal aorta and inferior vena cava in pregnant and nonpregnant women determined by magnetic resonance imaging. Anesthesiology. 2015 Feb;122(2):286-93. doi: 10.1097/ALN.0000000000000553. PubMed 25603203 ↗
  • Jones SJ, Kinsella SM, Donald FA. Comparison of measured and estimated angles of table tilt at Caesarean section. Br J Anaesth. 2003 Jan;90(1):86-7. PubMed 12488385 ↗
  • Aust H, Koehler S, Kuehnert M, Wiesmann T. Guideline-recommended 15 degrees left lateral table tilt during cesarean section in regional anesthesia-practical aspects: An observational study. J Clin Anesth. 2016 Aug;32:47-53. doi: 10.1016/j.jclinane.2015.12.041. Epub 2016 Mar 22. PubMed 27290944 ↗
  • Lee AJ, Landau R, Mattingly JL, Meenan MM, Corradini B, Wang S, Goodman SR, Smiley RM. Left Lateral Table Tilt for Elective Cesarean Delivery under Spinal Anesthesia Has No Effect on Neonatal Acid-Base Status: A Randomized Controlled Trial. Anesthesiology. 2017 Aug;127(2):241-249. doi: 10.1097/ALN.0000000000001737. PubMed 28598894 ↗

Individual participant data

Plan to share: No — Will not share patient identifiable data with other researchers.

08

Registry details

Key details

Study ID
NCT03455660
Lead sponsor
Columbia University
Responsible party
Allison Lee (Assistant Professor of Anesthesiology, Columbia University) — Principal investigator
First posted
Mar 6, 2018
Start date
Dec 2014
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Mar 6, 2018

Study contacts

Allison Lee, MD
principal investigator · Columbia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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