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An Evaluation of Maternal Position During Cesarean Delivery

A Randomized Controlled Trial Evaluating Maternal Tilt During Cesarean Section

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02872181
Enrollment
120
Registered
2016-08-19
Start date
2016-04-30
Completion date
2020-05-31
Last updated
2018-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

Keywords

Maternal Position, Tilt, Left Uterine Displacement, Cesarean Delivery, Cesarean Section

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.

Interventions

PROCEDURESupine

Placed in Supine position

PROCEDURELeft uterine displacement

Placed in 15 degrees left uterine displacement

Sponsors

Hartford Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
neonatal base deficit from uterine artery immediately after cesarean delivery of the fetusOne data point will be used. The neonatal gas from the uterine artery immediately after delivery

Secondary

MeasureTime frame
total phenylephrine use in micrograms prior to deliveryThe 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 delivery1 and 5 minute apgar scores of the newborn fetus will be compared

Countries

United States

Contacts

Primary Contactadam sachs, MD
asachs29@yahoo.com860-972-2117

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026