Fetal Pulse Oximetry Trial (FOX)

• Sponsor: The George Washington University Biostatistics Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00098709
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 10,000
• Locations: 13
• Duration (Months): 33.1
• Patients Per Site: 769.2
• Patients Per Site Per Month: 23.3

Study Details

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

• Study Type: Interventional
• 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 1, 2002
• Study Completion Date: Feb 1, 2005

Outcome Measures

Primary Outcome Measures

1. cesarean delivery (any indication) []

Secondary Outcome Measures

1. cesarean delivery for non-reassuring fetal heart rate []

2. cesarean delivery for dystocia []

3. neonatal morbidity []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama - Birmingham	Birmingham	Alabama	United States	35233
2	Northwestern University	Chicago	Illinois	United States	60611
3	Wayne State University	Detroit	Michigan	United States	48201
4	Columbia University	New York	New York	United States	10032
5	University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599
6	Wake Forest University School of Medicine	Winston-Salem	North Carolina	United States	27157
7	Case Western University	Cleveland	Ohio	United States	44109
8	Dexel University	Philadelphia	Pennsylvania	United States	19107
9	University of Pittsburgh Magee Womens Hospital	Pittsburgh	Pennsylvania	United States	15213
10	Brown University	Providence	Rhode Island	United States	02905
11	University of Texas - Southwest	Dallas	Texas	United States	75235
12	University of Texas - Houston	Houston	Texas	United States	77030
13	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

• 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The public website of the NICHD Maternal Fetal Medicine Units (MFMU) Network

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Segel SY, Carreño 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. Epub 2012 May 29.
• 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.

• Responsible Party: The George Washington University Biostatistics Center
• ClinicalTrials.gov Identifier: NCT00098709
• Other Study ID Numbers: HD36801-FOX; U10HD021410; U10HD027869; U10HD027917; U10HD027860; U10HD034116; U10HD034208; U10HD034136; U10HD040500; U10HD040485; U10HD040544; U10HD040545; U10HD040560; U10HD040512; U10HD036801
• First Posted: Dec 8, 2004
• Last Update Posted: Mar 18, 2022
• Last Verified: Mar 1, 2022

• Keywords provided by The George Washington University Biostatistics Center: pregnancy; labor, obstetric; fetal monitoring; oximetry; fetal heart rate; cardiotocography

Study Results

No Results Posted as of Mar 18, 2022