Recruiting

Maternal Position

Sponsor:

Hartford Hospital

Code:

NCT02872181

Conditions

Cesarean Section

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Supine

Left uterine displacement

Study Details

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.

Conditions

Cesarean Section

Study ID

NCT02872181

Start date

Apr, 2016

Status verified date

Jul, 2018

Completion date

May, 2020

Anticipated

Primary completion date

May, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: BMI <30

Pregnant women undergoing C/S with BMI <30

experimental: BMI 30-40

Pregnant women undergoing C/S with BMI 30-40

experimental: BMI >40

Pregnant women undergoing C/S with BMI >40

Interventions

Supine

Placed in Supine position

Left uterine displacement

Placed in 15 degrees left uterine displacement

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

adam sachs, MD

860-972-2117asachs29@yahoo.com

Locations

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Adam Sachs, MD

860-972-2117asachs29@yahoo.com

More Information

Sponsor

Hartford Hospital

Last update posted

Aug 1, 2018

Last verified

Jul, 2018

Keywords

  • Maternal Position
  • Tilt
  • Left Uterine Displacement
  • Cesarean Delivery
  • Cesarean Section

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2018-08-01.