An Evaluation of Maternal Position During Cesarean Delivery

July 31, 2018 updated by: Hartford Hospital

A Randomized Controlled Trial Evaluating Maternal Tilt During Cesarean Section

During Cesarean Delivery pregnant women are frequently tilted to the left 15 degress to reduce compression of the major blood vessels by the uterus. Despite this common practice, there is no conclusive evidence to support this practice. In fact it may even be deleterious to have women positioned in this position. The aim of the study is to determine whether or not tilting women to the left during cesarean section (CS) is helpful or detrimental. The authors hypothesize that left uterine displacement of 15 degrees, which is commonly employed, is useless for preventing compression of these blood vessels. To investigate this question, women will be randomly assigned to either be tilted 15 degrees to the left during CS or positioned flat on the table. Fetal acid base status, vasopressor/phenylephrine use, patient satisfaction, maternal complications, and fetal complications will all be collected and compared.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

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 Contact

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Hospital
        • Contact:

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • term pregnant women with an uncomplicated pregnancy course undergoing scheduled cesarean delivery

    • ≥18 years old
    • ASA 1 and 2 (i.e., patient is completely healthy (1) or has mild systemic disease (2)
    • Able and willing to consent to participate

Exclusion Criteria:

  • Males

    • <18 years old
    • maternal cardiac/pulmonary/hematologic disorders/renal failure
    • drug/alcohol/tobacco use during pregnancy
    • essential or pregnancy-induced hypertension
    • diabetes greater than 10 years
    • pre-eclampsia or abruptio placenta
    • <37 weeks gestation
    • hemoglobin < 7 g/dL
    • intrauterine growth retardation
    • fetal distress or fetal anomaly
    • Transverse lie
    • Ruptured membranes
    • Severe polyhydramnios or oligohydramnios
    • Multiple gestation
    • severe scoliosis or kyphosis,
    • uterine abnormalities (e.g., large fibroids, bicornuate uterus)
    • Failed spinal (sensory level < T6 after 15 minutes)
    • need to convert to general anesthesia before delivery

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMI <30
Pregnant women undergoing C/S with BMI <30
Procedure: Supine
Placed in Supine position
Procedure: Left uterine displacement
Placed in 15 degrees left uterine displacement
Experimental: BMI 30-40
Pregnant women undergoing C/S with BMI 30-40
Procedure: Supine
Placed in Supine position
Procedure: Left uterine displacement
Placed in 15 degrees left uterine displacement
Experimental: BMI >40
Pregnant women undergoing C/S with BMI >40
Procedure: Supine
Placed in Supine position
Procedure: Left uterine displacement
Placed in 15 degrees left uterine displacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
neonatal base deficit from uterine artery immediately after cesarean delivery of the fetus
Time Frame: One data point will be used. The neonatal gas from the uterine artery immediately after delivery
One data point will be used. The neonatal gas from the uterine artery immediately after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
total phenylephrine use in micrograms prior to delivery
Time Frame: The aggregate of the phenylephrine used immediately after spinal (total of 20 minutes) or until delivery of the baby
The aggregate of the phenylephrine used immediately after spinal (total of 20 minutes) or until delivery of the baby
APGAR scores of the newborn as assessed by the neonatologist immediately after cesarean delivery
Time Frame: 1 and 5 minute apgar scores of the newborn fetus will be compared
1 and 5 minute apgar scores of the newborn fetus will be compared

Collaborators and Investigators

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

Sponsor

Hartford Hospital

Investigators

  • Principal Investigator: adam sachs, MD, Hartford Hospital

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

April 1, 2016

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HartfordH

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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