An Evaluation of Maternal Position During Cesarean Delivery

Hartford Hospital

Status: Unknown

Conditions: Cesarean Section

Treatments: Procedure: Left uterine displacement; Procedure: Supine

Study type: Interventional

Funder types: Other

Identifiers

NCT02872181

HartfordH

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

BMI <30

Experimental group

Description:

Pregnant women undergoing C/S with BMI \<30

Treatment:

Procedure: Left uterine displacement

Procedure: Supine

BMI 30-40

Experimental group

Description:

Pregnant women undergoing C/S with BMI 30-40

Treatment:

Procedure: Left uterine displacement

Procedure: Supine

BMI >40

Experimental group

Description:

Pregnant women undergoing C/S with BMI \>40

Treatment:

Procedure: Left uterine displacement

Procedure: Supine