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PregnancyPhase 3NCT00098709

Fetal Pulse Oximetry Trial (FOX)

A Phase 3 study testing Fetal pulse oximeter in people with Pregnancy, run by The George Washington University Biostatistics Center at 13 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
Fetal pulse oximeter
Type of treatment
Medical device
How many people
10,000 participants
Where
13 sitesUnited States
Study dates
May 2002to Feb 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Need for immediate delivery
  • Planned cesarean delivery
  • Cervical dilatation > 6 cm
  • Known fetal anomaly or demise
  • Multifetal gestation
  • Maternal fever
Show all 14Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35233

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Northwestern University

    Chicago, Illinois, 60611

  • Case Western University

    Cleveland, Ohio, 44109

  • University of Texas - Southwest

    Dallas, Texas, 75235

  • Wayne State University

    Detroit, Michigan, 48201

  • University of Texas - Houston

    Houston, Texas, 77030

  • Columbia University

    New York, New York, 10032

  • Dexel University

    Philadelphia, Pennsylvania, 19107

  • University of Pittsburgh Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Brown University

    Providence, Rhode Island, 02905

  • University of Utah Medical Center

    Salt Lake City, Utah, 84132

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Randomized Clinical Trial of Fetal Pulse Oximetry

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.

Read the 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.

Conditions
Pregnancy
Being tested
Fetal pulse oximeter
Keywords
pregnancy, labor, obstetric, fetal monitoring, oximetry, fetal heart rate, cardiotocography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fetal pulse oximeterDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cesarean delivery (any indication)

Secondary outcomes (3)

  1. cesarean delivery for non-reassuring fetal heart rate

  2. cesarean delivery for dystocia

  3. neonatal morbidity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2004 (estimated)
  2. Study startMay 2002
  3. Study completionFeb 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00098709
Sponsor's protocol ID
HD36801-FOX
Other IDs
U10HD021410, U10HD027869, U10HD027917, U10HD027860, U10HD034116, U10HD034208, U10HD034136, U10HD040500
Status last verified
Mar 2022
First submitted
7 Dec 2004
Last updated
18 Mar 2022
Results posted
No

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.

    PubMed 9396924

  • 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.

    PubMed 11084540

  • 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.

    PubMed 17124017

  • 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.

    PubMed 19788967

  • 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.

    PubMed 20099218

  • 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.

    PubMed 22105260

  • 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.

    PubMed 21252738

  • 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.

    PubMed 22244471

  • 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.

    PubMed 22644826

  • 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.

    PubMed 22893556

  • 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.

    PubMed 26855099

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fetal pulse oximeter in people with Pregnancy, run by The George Washington University Biostatistics Center at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cesarean delivery (any indication). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00098709, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.

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