An Evaluation of Maternal Position During Cesarean Delivery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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BMI <30

Pregnant women undergoing C/S with BMI \<30

Group Type EXPERIMENTAL

Supine

Intervention Type PROCEDURE

Placed in Supine position

Left uterine displacement

Intervention Type PROCEDURE

Placed in 15 degrees left uterine displacement

BMI 30-40

Pregnant women undergoing C/S with BMI 30-40

Group Type EXPERIMENTAL

Supine

Intervention Type PROCEDURE

Placed in Supine position

Left uterine displacement

Intervention Type PROCEDURE

Placed in 15 degrees left uterine displacement

BMI >40

Pregnant women undergoing C/S with BMI \>40

Group Type EXPERIMENTAL

Supine

Intervention Type PROCEDURE

Placed in Supine position

Left uterine displacement

Intervention Type PROCEDURE

Placed in 15 degrees left uterine displacement

Interventions

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Supine

Placed in Supine position

Intervention Type PROCEDURE

Left uterine displacement

Placed in 15 degrees left uterine displacement

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes