An Evaluation of Maternal Position During Cesarean Delivery

Not Applicable

• Conditions: Cesarean Section
• Interventions: Procedure: Supine; Procedure: Left uterine displacement

• Registration Number: NCT02872181
• Lead Sponsor: Hartford Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-25
• Study Start: 2016-04
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-19
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMI 30-40	Left uterine displacement	Pregnant women undergoing C/S with BMI 30-40
BMI <30	Supine	Pregnant women undergoing C/S with BMI \<30
BMI <30	Left uterine displacement	Pregnant women undergoing C/S with BMI \<30
BMI >40	Supine	Pregnant women undergoing C/S with BMI \>40
BMI 30-40	Supine	Pregnant women undergoing C/S with BMI 30-40
BMI >40	Left uterine displacement	Pregnant women undergoing C/S with BMI \>40

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States