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

NCT02243423 | Completed DMC

• 1 other identifier: AAAO1851
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Aortocaval compression; Cesarean Section; Spinal Anesthesia; Phenylephrine

Outcome Measures

Primary Outcomes (1)

• Base deficit (umbilical artery) (mEq/L)

  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 Outcomes (1)

• Total phenylephrine dose (mg)

  15 minutes after spinal injection

Study Arms (2)

SUPINE group

EXPERIMENTAL

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

TILT group

ACTIVE COMPARATOR

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

Interventions

SUPINE PROCEDURE

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.

SUPINE group

TILT PROCEDURE

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.

TILT group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

New York Presbyterian, Allen Hospital

New York, New York, 10034, United States

Location

Related Publications (3)

• Lee SW, Khaw KS, Ngan Kee WD, Leung TY, Critchley LA. Haemodynamic effects from aortocaval compression at different angles of lateral tilt in non-labouring term pregnant women. Br J Anaesth. 2012 Dec;109(6):950-6. doi: 10.1093/bja/aes349. Epub 2012 Oct 11.

  PMID: 23059960 BACKGROUND

• Crawford JS, Burton M, Davies P. Time and lateral tilt at Caesarean section. Br J Anaesth. 1972 May;44(5):477-84. doi: 10.1093/bja/44.5.477. No abstract available.

  PMID: 5044078 BACKGROUND

• Cluver C, Novikova N, Hofmeyr GJ, Hall DR. Maternal position during caesarean section for preventing maternal and neonatal complications. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD007623. doi: 10.1002/14651858.CD007623.pub3.

  PMID: 23543552 BACKGROUND

MeSH Terms

Interventions

Supine Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Richard Smiley, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Virginia Apgar Professor of Anesthesiology at Columbia University Medical Center

Study Record Dates

• First Submitted: September 6, 2014
• First Posted: September 18, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 26, 2016

Record last verified: 2016-01

Locations

US (1)