ACOG Committee Opinion. Number 258, September 2001. Fetal pulse oximetry. 2001


The U.S. Food and Drug Administration recently approved the marketing of the Nellcor N-400 Fetal Oxygen Saturation Monitoring System, a fetal pulse oximeter. The American College of Obstetricians and Gynecologists Committee on Obstetric Practice cannot endorse the adoption of this device in clinical practice at this time because of concerns that its introduction could further escalate the cost of medical care without necessarily improving clinical outcome. The committee recommends that prospective randomized clinical trials be conducted to evaluate the clinical use of this new technology in conjunction with fetal well-being assessment.

UI MeSH Term Description Entries
D010092 Oximetry The determination of oxygen-hemoglobin saturation of blood either by withdrawing a sample and passing it through a classical photoelectric oximeter or by electrodes attached to some translucent part of the body like finger, earlobe, or skin fold. It includes non-invasive oxygen monitoring by pulse oximetry. Pulse Oximetry,Oximetry, Pulse,Oximetries,Oximetries, Pulse,Pulse Oximetries
D005323 Fetal Monitoring Physiologic or biochemical monitoring of the fetus. It is usually done during LABOR, OBSTETRIC and may be performed in conjunction with the monitoring of uterine activity. It may also be performed prenatally as when the mother is undergoing surgery. Monitoring, Fetal,Fetal Monitorings,Monitorings, Fetal
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014481 United States A country in NORTH AMERICA between CANADA and MEXICO.
D014486 United States Food and Drug Administration An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc. Food and Drug Administration (U.S.),USFDA,Food and Drug Administration,United States Food, Drug Administration
D018795 Device Approval Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA. Device Approval Process,New Device Approval,Food and Drug Administration Device Approval,Food and Drug Administration Device Approval Process,New Device Approval Process,Approval Process, Device,Approval Processes, Device,Approval, Device,Approval, New Device,Approvals, Device,Approvals, New Device,Device Approval Processes,Device Approval, New,Device Approvals,Device Approvals, New,New Device Approvals,Process, Device Approval,Processes, Device Approval

Related Publications

August 1992, International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,
January 2002, Gynecologie, obstetrique & fertilite,
February 2021, Obstetrics and gynecology,
Copied contents to your clipboard!