Fetal Pulse Oximetry Trial (FOX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00098709

Recruitment Status : Terminated

First Posted : December 8, 2004

Last Update Posted : March 18, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party):

The George Washington University Biostatistics Center

Study Description

Brief Summary:

The purpose of this study is to determine if the information provided to the physician by a fetal pulse oximeter during labor will reduce the chances of a cesarean delivery.

Condition or disease	Intervention/treatment	Phase
Pregnancy	Device: Fetal pulse oximeter	Phase 3

Detailed Description:

Information on fetal well-being during labor is of great importance to the managing physician. The current use of the fetal heart rate monitor provides some information on fetal condition, and is the primary tool used to determine if immediate operative delivery is required. The fetal pulse oximeter can provide additional information regarding fetal oxygen saturation.

Intervention: A fetal oxygen saturation sensor is placed in the uterus, between the fetal cheek or forehead and the uterine wall. In half of the patients, the managing physician will have access to fetal oxygen saturation and fetal heart rate monitoring. In the other half of the patients, labor will be monitored by fetal heart rate alone.

Study hypothesis: The additional information provided by the use of the fetal pulse oximeter will reduce the chances of a cesarean delivery. The primary outcome is cesarean section for any indication and secondary outcomes are cesarean delivery for non-reassuring fetal heart rate or dystocia, and neonatal morbidity.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Enrollment :	10000 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	A Randomized Clinical Trial of Fetal Pulse Oximetry
Study Start Date :	May 2002
Study Completion Date :	February 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

cesarean delivery (any indication)

Secondary Outcome Measures :

cesarean delivery for non-reassuring fetal heart rate
cesarean delivery for dystocia
neonatal morbidity

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Nulliparous
Singleton, cephalic pregnancy
Gestational age at least 36 weeks, 0 days
Cervical dilatation >= 2 cm
Station -2 or below (5ths scale)
Ruptured membranes
Internal monitoring devices placed

Exclusion criteria:

Need for immediate delivery
Planned cesarean delivery
Cervical dilatation > 6 cm
Known fetal anomaly or demise
Multifetal gestation
Maternal fever
Placenta previa
Previous uterine surgery
Active HSV infection
Known HIV or hepatitis infection
Diabetes requiring insulin
Heart disease requiring medication
Known chronic renal disease
Enrollment in another labor study

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098709

Locations

Layout table for location information

United States, Alabama
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35233
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, New York
Columbia University
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Case Western University
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
Dexel University
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02905
United States, Texas
University of Texas - Southwest
Dallas, Texas, United States, 75235
University of Texas - Houston
Houston, Texas, United States, 77030
United States, Utah
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

The George Washington University Biostatistics Center

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Layout table for investigator information

Study Director:	Cathy Spong, MD	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator:	Elizabeth A Thom, Ph.D.	George Washington University Biostatistics Center
Study Chair:	Steven L Bloom, M.D.	University of Texas

More Information

Additional Information:

The public website of the NICHD Maternal Fetal Medicine Units (MFMU) Network This link exits the ClinicalTrials.gov site

Publications:

Goffinet F, Langer B, Carbonne B, Berkane N, Tardif D, Le Goueff F, Laville M, Maillard F. Multicenter study on the clinical value of fetal pulse oximetry. I. Methodologic evaluation. The French Study Group on Fetal Pulse Oximetry. Am J Obstet Gynecol. 1997 Nov;177(5):1238-46. doi: 10.1016/s0002-9378(97)70045-0.

Garite TJ, Dildy GA, McNamara H, Nageotte MP, Boehm FH, Dellinger EH, Knuppel RA, Porreco RP, Miller HS, Sunderji S, Varner MW, Swedlow DB. A multicenter controlled trial of fetal pulse oximetry in the intrapartum management of nonreassuring fetal heart rate patterns. Am J Obstet Gynecol. 2000 Nov;183(5):1049-58. doi: 10.1067/mob.2000.110632.

Bloom SL, Spong CY, Thom E, Varner MW, Rouse DJ, Weininger S, Ramin SM, Caritis SN, Peaceman A, Sorokin Y, Sciscione A, Carpenter M, Mercer B, Thorp J, Malone F, Harper M, Iams J, Anderson G; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Fetal pulse oximetry and cesarean delivery. N Engl J Med. 2006 Nov 23;355(21):2195-202. doi: 10.1056/NEJMoa061170.

Rouse DJ, Weiner SJ, Bloom SL, Varner MW, Spong CY, Ramin SM, Caritis SN, Peaceman AM, Sorokin Y, Sciscione A, Carpenter MW, Mercer BM, Thorp JM Jr, Malone FD, Harper M, Iams JD, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Second-stage labor duration in nulliparous women: relationship to maternal and perinatal outcomes. Am J Obstet Gynecol. 2009 Oct;201(4):357.e1-7. doi: 10.1016/j.ajog.2009.08.003.

Contag SA, Clifton RG, Bloom SL, Spong CY, Varner MW, Rouse DJ, Ramin SM, Caritis SN, Peaceman AM, Sorokin Y, Sciscione A, Carpenter MW, Mercer BM, Thorp JM Jr, Malone FD, Iams JD. Neonatal outcomes and operative vaginal delivery versus cesarean delivery. Am J Perinatol. 2010 Jun;27(6):493-9. doi: 10.1055/s-0030-1247605. Epub 2010 Jan 22.

Robinson BK, Mapp DC, Bloom SL, Rouse DJ, Spong CY, Varner MW, Ramin SM, Sorokin Y, Sciscione A, Mercer BM, Thorp JM Jr, Malone FD, Harper M, Ehrenberg H. Increasing maternal body mass index and characteristics of the second stage of labor. Obstet Gynecol. 2011 Dec;118(6):1309-1313. doi: 10.1097/AOG.0b013e318236fbd1.

Rouse DJ, Weiner SJ, Bloom SL, Varner MW, Spong CY, Ramin SM, Caritis SN, Grobman WA, Sorokin Y, Sciscione A, Carpenter MW, Mercer BM, Thorp JM Jr, Malone FD, Harper M, Iams JD, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). Failed labor induction: toward an objective diagnosis. Obstet Gynecol. 2011 Feb;117(2 Pt 1):267-272. doi: 10.1097/AOG.0b013e318207887a.

Tita AT, Lai Y, Bloom SL, Spong CY, Varner MW, Ramin SM, Caritis SN, Grobman WA, Sorokin Y, Sciscione A, Carpenter MW, Mercer BM, Thorp JM Jr, Malone FD, Harper M, Iams JD. Timing of delivery and pregnancy outcomes among laboring nulliparous women. Am J Obstet Gynecol. 2012 Mar;206(3):239.e1-8. doi: 10.1016/j.ajog.2011.12.006. Epub 2011 Dec 16.

Segel SY, Carreno CA, Weiner SJ, Bloom SL, Spong CY, Varner MW, Rouse DJ, Caritis SN, Grobman WA, Sorokin Y, Sciscione A, Mercer BM, Thorp JM, Malone FD, Harper M, Iams JD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Relationship between fetal station and successful vaginal delivery in nulliparous women. Am J Perinatol. 2012 Oct;29(9):723-30. doi: 10.1055/s-0032-1314895. Epub 2012 May 29.

Costantine MM, Lai Y, Bloom SL, Spong CY, Varner MW, Rouse DJ, Ramin SM, Caritis SN, Peaceman AM, Sorokin Y, Sciscione A, Mercer BM, Thorp JM, Malone FD, Harper M, Iams JD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Population versus customized fetal growth norms and adverse outcomes in an intrapartum cohort. Am J Perinatol. 2013 Apr;30(4):335-41. doi: 10.1055/s-0032-1324708. Epub 2012 Aug 14.

Langen ES, Weiner SJ, Bloom SL, Rouse DJ, Varner MW, Reddy UM, Ramin SM, Caritis SN, Peaceman AM, Sorokin Y, Sciscione A, Carpenter MW, Mercer BM, Thorp JM Jr, Malone FD, Iams JD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Association of Cervical Effacement With the Rate of Cervical Change in Labor Among Nulliparous Women. Obstet Gynecol. 2016 Mar;127(3):489-495. doi: 10.1097/AOG.0000000000001299.

Layout table for additonal information

Responsible Party:	The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier:	NCT00098709
Other Study ID Numbers:	HD36801-FOX U10HD021410 ( U.S. NIH Grant/Contract ) U10HD027869 ( U.S. NIH Grant/Contract ) U10HD027917 ( U.S. NIH Grant/Contract ) U10HD027860 ( U.S. NIH Grant/Contract ) U10HD034116 ( U.S. NIH Grant/Contract ) U10HD034208 ( U.S. NIH Grant/Contract ) U10HD034136 ( U.S. NIH Grant/Contract ) U10HD040500 ( U.S. NIH Grant/Contract ) U10HD040485 ( U.S. NIH Grant/Contract ) U10HD040544 ( U.S. NIH Grant/Contract ) U10HD040545 ( U.S. NIH Grant/Contract ) U10HD040560 ( U.S. NIH Grant/Contract ) U10HD040512 ( U.S. NIH Grant/Contract ) U10HD036801 ( U.S. NIH Grant/Contract )
First Posted:	December 8, 2004 Key Record Dates
Last Update Posted:	March 18, 2022
Last Verified:	March 2022

Keywords provided by The George Washington University Biostatistics Center:


pregnancy labor, obstetric fetal monitoring	oximetry fetal heart rate cardiotocography

To Top