Non-reassuring fetal status: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

Vaccine

Volumn 34, Issue 49, 2016, Pages 6084-6092

  Gravett, Courtney ^a   Eckert, Linda O ^b   Gravett, Michael G ^b   Dudley, Donald J ^c   Stringer, Elizabeth M ^d   Mujobu, Tresor Bodjick Muena ^e   Lyabis, Olga ^f   Kochhar, Sonali ^g   Swamy, Geeta K ^h  

^a SEATTLE CHILDREN S HOSPITAL   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c UNIVERSITY OF VIRGINIA   (United States)

^d UNIVERSITY OF NORTH CAROLINA   (United States)

^e UNIVERSITY OF KINSHASA   (Congo)

^f Sanofi Pasteur   (Russian Federation)

^g Global Healthcare Consulting   (India)

^h DUKE UNIVERSITY   (United States)

Author keywords

Adverse event; Case definition; Fetal distress; Fetal intolerance to labor; Guidelines; Immunization; Non reassuring fetal status

Indexed keywords

VACCINE;

ARTICLE; AUTOPSY; DATA ANALYSIS; DRUG SAFETY; FETUS HYPOXIA; HUMAN; INFORMATION PROCESSING; PRACTICE GUIDELINE; PRIORITY JOURNAL; UMBILICAL CORD BLOOD; VACCINATION; DRUG SURVEILLANCE PROGRAM; FEMALE; FETUS DISTRESS; IMMUNIZATION;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DATA COLLECTION; FEMALE; FETAL DISTRESS; GUIDELINES AS TOPIC; HUMANS; IMMUNIZATION; VACCINES;

EID: 84979256188     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2016.03.043     Document Type: Article

References (42)

1. [1] Parer, J.T., Livingston, E.G., What is fetal distress?. Am J Obstet Gynecol 162 (1990), 1421–1425 discussion 5–7.
2. [2] Bernardes, J., Costa-Pereira, A., Ayres-de-Campos, D., van Geijn, H.P., Pereira-Leite, L., Evaluation of interobserver agreement of cardiotocograms. Int J Gynaecol Obstet Off Organ Int Federat Gynaecol Obstet 57 (1997), 33–37.
3. [3] Blackwell, S.C., Grobman, W.A., Antoniewicz, L., Hutchinson, M., Gyamfi Bannerman, C., Interobserver and intraobserver reliability of the NICHD 3-Tier Fetal Heart Rate Interpretation System. Am J Obstet Gynecol 205 (2011), e1–e5 378.
4. [4] Rhose, S., Heinis, A.M., Vandenbussche, F., van Drongelen, J., van Dillen, J., Inter- and intra-observer agreement of non-reassuring cardiotocography analysis and subsequent clinical management. Acta Obstet Gynecol Scand 93 (2014), 596–602.
5. [5] Penning, S., Garite, T.J., Management of fetal distress. Obstet Gynecol Clin N Am 26 (1999), 259–274.
6. [6] Practice, ACoO., Inappropriate use of the terms fetal distress and birth asphyxia, Committee Opinion 326. Obstet Gynecol 106 (2005), 1469–1470.
7. [7] Martin, C.B. Jr., Normal fetal physiology and behavior, and adaptive responses with hypoxemia. Sem Perinatol 32 (2008), 239–242.
8. [8] Murray, M., Antepartal and intrapartal fetal monitoring. 3rd ed., 2007, Springer Publishing Company, LLC, New York.
9. [9] Fahey, J., King, T.L., Intrauterine asphyxia: clinical implications for providers of intrapartum care. J Midw Womens Health 50 (2005), 498–506.
10. [10] Executive summary: neonatal encephalopathy and neurologic outcome, second edition, report of the American College of Obstetricians and Gynecologists’ Task Force on Neonatal Encephalopathy. Obstet Gynecol 123 (2014), 896–901.
11. [11] Hankins, G.D., Speer, M., Defining the pathogenesis and pathophysiology of neonatal encephalopathy and cerebral palsy. Obstet Gynecol 102 (2003), 628–636.
12. [12] East, C.E., Leader, L.R., Sheehan, P., Henshall, N.E., Colditz, P.B., Lau, R., Intrapartum fetal scalp lactate sampling for fetal assessment in the presence of a non-reassuring fetal heart rate trace. Cochrane Database Syst Rev, 5, 2015, CD006174.
13. [13] Ugwumadu, A., Understanding cardiotocographic patterns associated with intrapartum fetal hypoxia and neurologic injury. Best Pract Res Clin Obstet Gynaecol 27 (2013), 509–536.
14. [14] Low, J.A., Victory, R., Derrick, E.J., Predictive value of electronic fetal monitoring for intrapartum fetal asphyxia with metabolic acidosis. Obstet Gynecol 93 (1999), 285–291.
15. [15] Hofmeyr, G.J., Haws, R.A., Bergstrom, S., Lee, A.C., Okong, P., Darmstadt, G.L., et al. Obstetric care in low-resource settings: what, who, and how to overcome challenges to scale up?. Int J Gynaecol Obstet Off Organ Int Federat Gynaecol Obstet, 107(Suppl. 1), 2009 S21–44, S-5.
16. [16] Alfirevic, Z., Devane, D., Gyte, G.M., Continuous cardiotocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labour. Cochrane Database Syst Rev, 2006 CD660060.
17. [17] Lewis, D., Downe, S., panel. Fifmc. FIGO consensus guidelines on intrapartum fetal monitoring: intermittent auscultation. Int J Gynecol Obstet 131 (2015), 9–12.
18. [18] Alfirevic, Z., Devane, D., Gyte, G.M., Continuous cardiotocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labour. Cochrane Database Syst Rev, 5, 2013 CD006066.
19. [19] Electronic fetal heart rate monitoring: research guidelines for interpretation. National Institute of Child Health and Human Development Research Planning Workshop. Am J Obstet Gynecol, 1997, 177–190 1385.
20. [20] Macones, G.A., Hankins, G.D., Spong, C.Y., Hauth, J., Moore, T., The 2008 National Institute of Child Health and Human Development workshop report on electronic fetal monitoring: update on definitions, interpretation, and research guidelines. Obstet Gynecol 112 (2008), 661–666.
21. [21] American College of Gynecologists, Practice bulletin no. 116: management of intrapartum fetal heart rate tracings. Obstet Gynecol 116 (2010), 1232–1240.
22. [22] Ayres-de-Campos, D., Sabaratnam, A., panel. Fifmec. FIGO consensus guidelines on intrapartum fetal monitoring: introduction. Int J Gynecol Obstet 131 (2015), 3–4.
23. [23] Ayres-de-Campos, D., Sabaratnam, A., panel. Fifmec. FIGO consensus guidelines on intrapartum fetal monitoring: physiology of fetal oxygenation and the main goals of intrapartum fetal monitoring. Int J Gynecol Obstet 131 (2015), 5–8.
24. [24] Ayres-de-Campo, D., Spong, C.Y., Chandraharan, E., panel. Fifmec. FIGO consensus guidelines on intrapartum fetal monitoring: cardiotocography. Int J Gynecol Obstet 131 (2015), 13–24.
25. [25] Medicine, FsoSiP., Guidelines for the use of fetal monitoring. Int J Gynecol Obstet 25 (1987), 159–167.
26. [26] Visser, G., Ayres-de-Campos, D., panel. Fifmec. FIGO consensus guidelines on intrapartum fetal monitoring: adjunctive technologies. Int J Gynecol Obstet 131 (2015), 25–29.
27. [27] Adedinsewo, D.A., Noory, L., Bednarczyk, R.A., Steinhoff, M.C., Davis, R., Ogbuanu, C., et al. Impact of maternal characteristics on the effect of maternal influenza vaccination on fetal outcomes. Vaccine 31 (2013), 5827–5833.
28. [28] Donegan, K., King, B., Bryan, P., Safety of pertussis vaccination in pregnant women in UK: observational study. BMJ, 349, 2014, 4219g.
29. [29] Munoz, F.M., Bond, N.H., Maccato, M., Pinell, P., Hammill, H.A., Swamy, G.K., et al. Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial. JAMA 311 (2014), 1760–1769.
30. [30] Karsdorp, V.H., van Vugt, J.M., van Geijn, H.P., Kostense, P.J., Arduini, D., Montenegro, N., et al. Clinical significance of absent or reversed end diastolic velocity waveforms in umbilical artery. Lancet 344 (1994), 1664–1668.
31. [31] Maulik, D., Absent end diastolic velocity in the umbilical artery and its clinical significance. Maulik, D., (eds.) Doppler ultrasound in obstetrics and gynecology, 2nd ed., 2005, Springer-Verlag, New York.
32. [32] Valcamonico, A., Danti, L., Frusca, T., Soregaroli, M., Zucca, S., Abrami, F., et al. Absent end-diastolic velocity in umbilical artery: risk of neonatal morbidity and brain damage. Am J Obstet Gynecol 170 (1994), 796–801.
33. [33] Yoon, B.H., Romero, R., Roh, C.R., Kim, S.H., Ager, J.W., Syn, H.C., et al. Relationship between the fetal biophysical profile score, umbilical artery Doppler velocimetry, and fetal blood acid–base status determined by cordocentesis. Am J Obstet Gynecol 169 (1993), 1586–1594.
34. [34] Alfirevic, Z., Stampalija, T., Gyte, G.M., Fetal and umbilical Doppler ultrasound in high-risk pregnancies. Cochrane Database Syst Rev, 11, 2013, CD007529.
35. [35] Hopp, H., Nonnenmacher, A., Evidence-based fetal assessment. Gynakol Geburtsmed Gynakol Endokrinol 4 (2008), 134–148.
36. [36] Saling, E., Blood gas relations and the acid–base equilibrium of the fetus in an uncomplicated course of delivery. Zeitschrift Geburtshilfe Gynakologie 161 (1964), 262–292.
37. [37] Maiques, V., Garcia-Tejedor, A., Perales, A., Navarro, C., Intrapartum fetal invasive procedures and perinatal transmission of HIV. Eur J Obstet Gynecol Reprod Biol 87 (1999), 63–67.
38. [38] Jibodu, O.A., Arulkumaran, S., Intrapartum fetal surveillance. Curr Opin Obstet Gynecol 12 (2000), 123–127.
39. [39] Practice, ACoO., ACOG Committee Opinion No. 348, November 2006: umbilical cord blood gas and acid–base analysis. Obstet Gynecol 108 (2006), 1319–1322.
40. [40] Apgar, V., A proposal for a new method of evaluation of the newborn infant. Curr Res Anes Anal 32 (1953), 260–267.
41. [41] Leuthner, S.R., Das, U.G., Low Apgar scores and the definition of birth asphyxia. Pediatr Clin N Am 51 (2004), 737–745.
42. [42] Manganaro, R., Mami, C., Gemelli, M., The validity of the Apgar scores in the assessment of asphyxia at birth. Eur J Obstet Gynecol Reprod Biol 54 (1994), 99–102.