Clinical trial NCT02872181: An Evaluation of Maternal Position During Cesarean Delivery
Official title: A Randomized Controlled Trial Evaluating Maternal Tilt During Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section
Keywords: Maternal Position
Tilt
Left Uterine Displacement
Cesarean Delivery
Cesarean Section
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: neonatal base deficit from uterine artery immediately after cesarean delivery of the fetus
timeFrame: One data point will be used. The neonatal gas from the uterine artery immediately after delivery
Secondary outcomes:
measure: total phenylephrine use in micrograms prior to delivery
timeFrame: The aggregate of the phenylephrine used immediately after spinal (total of 20 minutes) or until delivery of the baby
measure: APGAR scores of the newborn as assessed by the neonatologist immediately after cesarean delivery
timeFrame: 1 and 5 minute apgar scores of the newborn fetus will be compared
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: adam sachs, MD
role: PRINCIPAL_INVESTIGATOR
References: