An Evaluation of Maternal Position During Cesarean Delivery

Study Overview
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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.

Official Title
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A Randomized Controlled Trial Evaluating Maternal Tilt During Cesarean Section

Conditions
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Cesarean Section

Intervention / Treatment
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* Procedure: Supine
* Procedure: Left uterine displacement


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maternal Position, Tilt, Left Uterine Displacement, Cesarean Delivery, Cesarean Section