NCT02872181

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

4.1 years

First QC Date

January 25, 2016

Last Update Submit

July 31, 2018

Conditions

Cesarean Section

Keywords

Maternal PositionTiltLeft Uterine DisplacementCesarean DeliveryCesarean Section

Outcome Measures

Primary Outcomes (1)

  • neonatal base deficit from uterine artery immediately after cesarean delivery of the fetus

    One data point will be used. The neonatal gas from the uterine artery immediately after delivery

Secondary Outcomes (2)

  • total phenylephrine use in micrograms prior to delivery

    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

    1 and 5 minute apgar scores of the newborn fetus will be compared

Study Arms (3)

BMI <30

EXPERIMENTAL

Pregnant women undergoing C/S with BMI \<30

Procedure: SupineProcedure: Left uterine displacement

BMI 30-40

EXPERIMENTAL

Pregnant women undergoing C/S with BMI 30-40

Procedure: SupineProcedure: Left uterine displacement

BMI >40

EXPERIMENTAL

Pregnant women undergoing C/S with BMI \>40

Procedure: SupineProcedure: Left uterine displacement

Interventions

SupinePROCEDURE

Placed in Supine position

BMI 30-40BMI <30BMI >40
Left uterine displacementPROCEDURE

Placed in 15 degrees left uterine displacement

BMI 30-40BMI <30BMI >40

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

MeSH Terms

Interventions

Supine Position

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • adam sachs, MD

    Hartford Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

adam sachs, MD

CONTACT

860-972-2117asachs29@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2016

First Posted

August 19, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

August 1, 2018

Record last verified: 2018-07

Locations

US(1)