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

NCT03455660 | Completed DMC

• 1 other identifier: AAAR7164
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cesarean Delivery

Keywords

Cesarean; C-Section

Outcome Measures

Primary Outcomes (1)

• Umbilical artery base excess

  Base excess calculation of umbilical artery blood

  10 minutes

Secondary Outcomes (1)

• Umbilical artery pH

  10 minutes

Study Arms (2)

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

no intervention OTHER

no intervention

Post-January 2016; Pre-January 2015

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

NewYork Presbyterian/The Allen Hospital

New York, New York, 10034, United States

Location

Related Publications (5)

• 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.

  PMID: 28759487 BACKGROUND

• 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.

  PMID: 25603203 BACKGROUND

• 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.

  PMID: 12488385 BACKGROUND

• 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.

  PMID: 27290944 BACKGROUND

• 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.

  PMID: 28598894 BACKGROUND

Study Officials

• Allison Lee, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: March 6, 2018
• Study Start: December 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 6, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)