NCT00098709

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for phase_3 pregnancy

Timeline
Completed

Started May 2002

Geographic Reach
1 country

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

First QC Date

December 7, 2004

Last Update Submit

March 16, 2022

Conditions

Pregnancy

Keywords

pregnancylabor, obstetricfetal monitoringoximetryfetal heart ratecardiotocography

Outcome Measures

Primary Outcomes (1)

  • cesarean delivery (any indication)

Secondary Outcomes (3)

  • cesarean delivery for non-reassuring fetal heart rate

  • cesarean delivery for dystocia

  • neonatal morbidity

Interventions

Fetal pulse oximeterDEVICE

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of Alabama - Birmingham

Birmingham, Alabama, 35233, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Case Western University

Cleveland, Ohio, 44109, United States

Location

Dexel University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Brown University

Providence, Rhode Island, 02905, United States

Location

University of Texas - Southwest

Dallas, Texas, 75235, United States

Location

University of Texas - Houston

Houston, Texas, 77030, United States

Location

University of Utah Medical Center

Salt Lake City, Utah, 84132, United States

Location

Related Publications (11)

  • 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.

    PMID: 9396924BACKGROUND

  • 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.

    PMID: 11084540BACKGROUND

  • 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.

    PMID: 17124017BACKGROUND

  • 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.

    PMID: 19788967BACKGROUND

  • 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.

    PMID: 20099218BACKGROUND

  • 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.

    PMID: 22105260BACKGROUND

  • 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.

    PMID: 21252738BACKGROUND

  • 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.

    PMID: 22244471BACKGROUND

  • 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.

    PMID: 22644826BACKGROUND

  • 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.

    PMID: 22893556BACKGROUND

  • 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.

    PMID: 26855099BACKGROUND

Related Links

Study Officials

  • Cathy Spong, MD

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

    STUDY DIRECTOR

  • Elizabeth A Thom, Ph.D.

    George Washington University Biostatistics Center

    PRINCIPAL INVESTIGATOR

  • Steven L Bloom, M.D.

    University of Texas

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2004

First Posted

December 8, 2004

Study Start

May 1, 2002

Study Completion

February 1, 2005

Last Updated

March 18, 2022

Record last verified: 2022-03

Locations

US(13)