Oxygen for Intrauterine Resuscitation of Category II Fetal Heart Tracings

NCT02741284 | Completed Results DMC

• 1 other identifier: 201602164
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Maternal oxygen administration for concerning fetal heart rate tracing (FHT) patterns is common practice on Labor and Delivery units in the United States. Despite the broad use of oxygen, it is unclear if this practice is beneficial for the fetus. The purpose of this study is to compare oxygen to room air in patients with Category II fetal heart tracings with regard to neonatal acid-base status, subsequent tracings, and production of reactive oxygen species

Conditions

Electronic Fetal Monitoring; Fetal Hypoxia; Fetal-Placental Circulation

Outcome Measures

Primary Outcomes (1)

• Mean Umbilical Artery Lactate at Delivery

  Determined by umbilical artery cord gas collected at time of delivery and only in patients with paired (umbilical artery and umbilical vein) cord gases.

  At delivery

Secondary Outcomes (5)

• Umbilical Artery pH

  At time of delivery

• Mode of Delivery

  At delivery

• Umbilical Artery pCO2

  At time of delivery

• Umbilical Artery pO2

  Time of delivery

• Umbilical Artery Base Deficit

  At time of delivery

Other Outcomes (1)

• Number of Patients With Resolved Recurrent Decelerations

  60 minutes after randomization

Study Arms (2)

No Oxygen

EXPERIMENTAL

Room air

Drug: Room air

Oxygen

ACTIVE COMPARATOR

10L oxygen by nonrebreather mask

Drug: 10L Oxygen by nonrebreather mask

Interventions

Room air DRUG

No Oxygen

10L Oxygen by nonrebreather mask DRUG

Oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Term, singleton patients admitted to Labor\& Delivery for spontaneous labor or labor induction

You may not qualify if:

• Multiple pregnancy
• Significant fetal anomalies
• Category III FHT
• Umbilical artery doppler abnormalities
• Maternal hypooxygenation or need for oxygen

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (17)

• Robinson B, Nelson L. A Review of the Proceedings from the 2008 NICHD Workshop on Standardized Nomenclature for Cardiotocography: Update on Definitions, Interpretative Systems With Management Strategies, and Research Priorities in Relation to Intrapartum Electronic Fetal Monitoring. Rev Obstet Gynecol. 2008 Fall;1(4):186-92.

  PMID: 19173023 BACKGROUND

• Khazin AF, Hon EH, Hehre FW. Effects of maternal hyperoxia on the fetus. I. Oxygen tension. Am J Obstet Gynecol. 1971 Feb 15;109(4):628-37. doi: 10.1016/0002-9378(71)90639-9. No abstract available.

  PMID: 5100084 BACKGROUND

• Althabe O Jr, Schwarcz RL, Pose SV, Escarcena L, Caldeyro-Barcia R. Effects on fetal heart rate and fetal pO2 of oxygen administration to the mother. Am J Obstet Gynecol. 1967 Jul 15;98(6):858-70. doi: 10.1016/0002-9378(67)90205-0. No abstract available.

  PMID: 6027716 BACKGROUND

• Thorp JA, Trobough T, Evans R, Hedrick J, Yeast JD. The effect of maternal oxygen administration during the second stage of labor on umbilical cord blood gas values: a randomized controlled prospective trial. Am J Obstet Gynecol. 1995 Feb;172(2 Pt 1):465-74. doi: 10.1016/0002-9378(95)90558-8.

  PMID: 7856671 BACKGROUND

• Nesterenko TH, Acun C, Mohamed MA, Mohamed AN, Karcher D, Larsen J Jr, Aly H. Is it a safe practice to administer oxygen during uncomplicated delivery: a randomized controlled trial? Early Hum Dev. 2012 Aug;88(8):677-81. doi: 10.1016/j.earlhumdev.2012.02.007. Epub 2012 Mar 23.

  PMID: 22445187 BACKGROUND

• Khaw KS, Wang CC, Ngan Kee WD, Pang CP, Rogers MS. Effects of high inspired oxygen fraction during elective caesarean section under spinal anaesthesia on maternal and fetal oxygenation and lipid peroxidation. Br J Anaesth. 2002 Jan;88(1):18-23. doi: 10.1093/bja/88.1.18.

  PMID: 11883375 BACKGROUND

• Tuuli MG, Stout MJ, Shanks A, Odibo AO, Macones GA, Cahill AG. Umbilical cord arterial lactate compared with pH for predicting neonatal morbidity at term. Obstet Gynecol. 2014 Oct;124(4):756-761. doi: 10.1097/AOG.0000000000000466.

  PMID: 25198278 BACKGROUND

• Westgren M, Divon M, Horal M, Ingemarsson I, Kublickas M, Shimojo N, Nordstrom L. Routine measurements of umbilical artery lactate levels in the prediction of perinatal outcome. Am J Obstet Gynecol. 1995 Nov;173(5):1416-22. doi: 10.1016/0002-9378(95)90627-4.

  PMID: 7503179 BACKGROUND

• Cahill AG, Roehl KA, Odibo AO, Macones GA. Association and prediction of neonatal acidemia. Am J Obstet Gynecol. 2012 Sep;207(3):206.e1-8. doi: 10.1016/j.ajog.2012.06.046.

  PMID: 22939728 BACKGROUND

• Frey HA, Tuuli MG, Shanks AL, Macones GA, Cahill AG. Interpreting category II fetal heart rate tracings: does meconium matter? Am J Obstet Gynecol. 2014 Dec;211(6):644.e1-8. doi: 10.1016/j.ajog.2014.06.033. Epub 2014 Jun 17.

  PMID: 24949543 BACKGROUND

• Dalle-Donne I, Rossi R, Colombo R, Giustarini D, Milzani A. Biomarkers of oxidative damage in human disease. Clin Chem. 2006 Apr;52(4):601-23. doi: 10.1373/clinchem.2005.061408. Epub 2006 Feb 16.

  PMID: 16484333 BACKGROUND

• Ilhan N, Ilhan N, Simsek M. The changes of trace elements, malondialdehyde levels and superoxide dismutase activities in pregnancy with or without preeclampsia. Clin Biochem. 2002 Jul;35(5):393-7. doi: 10.1016/s0009-9120(02)00336-3.

  PMID: 12270770 BACKGROUND

• Pryor WA, Stanley JP. Letter: A suggested mechanism for the production of malonaldehyde during the autoxidation of polyunsaturated fatty acids. Nonenzymatic production of prostaglandin endoperoxides during autoxidation. J Org Chem. 1975 Nov 28;40(24):3615-7. doi: 10.1021/jo00912a038. No abstract available.

  PMID: 1185332 BACKGROUND

• Suhail M, Suhail S, Gupta BK, Bharat V. Malondialdehyde and Antioxidant Enzymes in Maternal and Cord Blood, and their Correlation in Normotensive and Preeclamptic Women. J Clin Med Res. 2009 Aug;1(3):150-7. doi: 10.4021/jocmr2009.07.1252. Epub 2009 Aug 12.

  PMID: 22493649 BACKGROUND

• Lorente L, Martin MM, Abreu-Gonzalez P, Dominguez-Rodriguez A, Labarta L, Diaz C, Sole-Violan J, Ferreres J, Cabrera J, Igeno JC, Jimenez A. Sustained high serum malondialdehyde levels are associated with severity and mortality in septic patients. Crit Care. 2013 Dec 11;17(6):R290. doi: 10.1186/cc13155.

  PMID: 24326199 BACKGROUND

• Lorente L, Martin MM, Abreu-Gonzalez P, Ramos L, Argueso M, Caceres JJ, Sole-Violan J, Lorenzo JM, Molina I, Jimenez A. Association between serum malondialdehyde levels and mortality in patients with severe brain trauma injury. J Neurotrauma. 2015 Jan 1;32(1):1-6. doi: 10.1089/neu.2014.3456.

  PMID: 25054973 BACKGROUND

• Raghuraman N, Wan L, Temming LA, Woolfolk C, Macones GA, Tuuli MG, Cahill AG. Effect of Oxygen vs Room Air on Intrauterine Fetal Resuscitation: A Randomized Noninferiority Clinical Trial. JAMA Pediatr. 2018 Sep 1;172(9):818-823. doi: 10.1001/jamapediatrics.2018.1208.

  PMID: 30039159 DERIVED

MeSH Terms

Conditions

Fetal Hypoxia

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Nandini Raghuraman
• Organization: Washington University in St Louis

nraghuraman@wustl.edu

314 362 7300

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2016
• First Posted: April 18, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2020
• Last Updated: November 26, 2021
• Results First Posted: November 2, 2018

Record last verified: 2021-11

Locations

US (1)