62 APPENDIX 2: RESEARCH PROFORMA
PART II DISSERTATION ON THE ACCURACY OF MONOCLONAL ANTIBODY TEST
63 b. Unbooked [ ]
11. Date of Delivery--- 12. Results
TEST POSITIVE NEGATIVE
POOLING NITRAZINE FERNING AmniSURE
13. State of the Membrane at Labour or Delivery a. Intact [ ]
b. Already Ruptured [ ]
64 REFERENCES
1. American College of Obstetricians and Gynaecologists (ACOG), Committee on Practice Bulletins. Premature Rupture of Membranes.
Clinical Management Guidelines for Obstetrician-Gynaecologists, No 80.
Washington, DC: ACOG; April 2007.
2. Royal College of Obstetrician-Gynaecologists (RCOG), Scientific Advisory Committee. Preterm Prelabour Rupture of Membranes. Clinical Green Top Guidelines No. 44. London, UK: RCOG; November 2006: 381-391.
Availableat: http://www.rcog.org.uk/resources/Public/pdf/green_top44_
preterm.pdf. Accessed on June 1, 2010.
3. Yild C, Tanir H, Sener T. Comparison of Conventional Methods (Nitrazine test, Ferning test) and Placental Alpha- Microglobulin-1 (PAMG-1) in Cervicovaginal Discharge for the Diagnosis of Rupture of Membranes.
International Journal of Gynaecology and Obstetrics, 2009; 107(supl 2):
S530.
4. Orhue AAE. Preterm Labour and Premature Rupture of Membranes. In:
Agboola A (ed). Textbook of Obstetrics and Gynaecology for Medical Students. 2nd Edition, Heinemann Educational Books Nigeria Plc, Ibadan;
2006:423-429.
5. Odunsi A, Odutayo R. Premature Rupture of Fetal Membranes. In:
Okonofua F, Odunsi K (eds). Contemporary Obstetrics and Gynaecology for Developing Countries. Women’s Health and Action Research Centre;
2003: 430-453.
65 6. Obi SN, Ozumba BC. Pre-term Premature Rupture of Fetal Membranes:
The Dilemma of Management in a Developing Nation. J Obstet Gynaecol.
2007 Jan; 27(1):37-40.
7. Hosseini MA, Nahidi F, Majdfar Z. Comparison of Fern and Evaporation Tests for Detection of Ruptured Fetal Membranes. Eastern Mediterranean Health Journal, 2007 Jan; 13(1):197-200.
8. Alexander JM, Cox SM. Clinical Course of Premature Rupture of the Membranes. Seminars in Perinatology, 1996 Oct;20(5): 369-37
9. Okonofua FE, Onwudiegwu U, Odunsi OA. Premature Rupture of Fetal Membranes in a Low Socio-economic Population: Results of Conservative Management. International Journal of Obstetrics and Gynaecology, January 1991; 34(1):35-39.
10. Liu J, Feng Z, Wu J. The Incidence Rate of Premature Rupture of Membranes and its Influence on Fetal-neonatal Health. Journal of Tropical Paediatrics, 2010; 56(1):36-42.
11. Dare FO, Ademowore AS, Ogunniyi S. Experience with 159 Cases of Premature Rupture of Fetal Membranes in Ile-Ife, Nigeria. Trop Doctor, 1989; 19:160-2.
12. Etuk SJ, Etuk IS, Oyo-Ita AE. Factors Influencing the Incidence of Pre-term Birth in Calabar, Nigeria. Nigerian Journal of Physiological Sciences, 2005; 20 (1-2): 63-68.
13. Ezechi OC, Makinde ON, Kalu BE, Nnatu SN. Risk Factors for Preterm Delivery in South Western Nigeria. J Obstet Gynaecol. 2003 Jul;
23(4):387-91.
66 14. Osaikhuwuomwan JA, Okpere EE, Okonkwo CA, Ande AB, Idogun ES.
Plasma Vitamin C Levels and Risk of Preterm Prelabour Rupture of Membranes. Arch Gynaecol Obstet. 2011 Sep; 284(3):593-7.
15. Omole-Ohonsi A, Ashimi A, Adeleke S. Spontaneous Pre-labour Rupture of Membranes at Term: Immediate versus Delayed Induction of Labour.
West Afr J Med. 2009 May; 28(3):156-60.
16. Oboro VO, Adekanle BA, Apantaku BD, Onadipe OA. Pre-term Prelabour Rupture of Membranes. Effects of Chorioamnionitis on Overall Neonatal Outcome. J Obstet Gynaecol, 2006; 26: 740-743.
17. Yamada H, Fujimoto S. Rapid Diagnosis of Premature Rupture of Membranes using a New Kit Employing Anti-AFP Monoclonal Antibody.
Arch Gynaecol Obstet, 1995; 256:57-61.
18. Callahan TL, Caughey AB. Normal Labour and Delivery. Blueprint Obstetrics; 2008: 35-37.
19. Kwawukume EY. Premature Rupture of Membranes. In: Kwawukume EY, Emuveyan EE (eds). Comprehensive Obstetrics in the Tropics.1st Edition.
Asante and Hittscher, Accra; 2002: 151-156.
20. Medina TM, Hill DA. Preterm Premature Rupture of Membranes:
Diagnosis and Management. Am Fam Physician. 2006; 73(4):659-664.
21. Cousins LM, Smok DP, Lovett SM, Poeltler DM. AmniSure Placental Alpha Microglobulin-1 Rapid Immunoassay versus Standard Diagnostic Methods for Detection of Rupture of Membranes. Am J Perinatol. 2005 Aug; 22(6):317-320.
22. Salama N.Clinical Review Criteria. AmniSure ROM (Rupture of Fetal Membrane) Test. AmniSure Placental Alpha Microglobulin-1 Rapid
67 Immunoassay for detection of Rupture of Membranes. Group health Cooperative; 2010.
23. Lee SE, Park JS, Norwitz ER, Kim KW, Park HS, Jun JK. Measurement of Placental Alpha-microglobulin-1 in Cervicovaginal Discharge to Diagnose Rupture of Membranes. Obstet Gynaecol. 2007 Mar; 109(3):634-640.
24. Boltovskaia MN, Zaraiskii EI, Fuks BB, Sukhikh GT, Kalafati TI, Starosvetskaia NA, Nazimova SV, Mashitskaia MI, Likharev VA.
Histochemical and Clinical-Diagnostic Study of Placental Alpha 1-microglobulin using Monoclonal Antibodies. Biull Eksp Biol Med. 1991 Oct; 112(10):397–400.
25. Tkachenko OA, Petrunin DD. Immunochemical Studies of the System of Specific Proteins of the human Placenta. Vestn Ross Akad Med Nauk.
1995; 3:40-44.
26. Lodeiro JG, Hsieh KA, Byers JH, Feinstein SJ. The Fingerprints, a False-positive Fern Test. Obstet Gynaecol 1989; 73:873
27. McGregor JA, Johnson S. “Fig-Leaf”Ferning and Positive Nitrazine Testing: Semen as a Cause of Misdiagnosis of Premature Rupture of Membranes. Am J Obstet Gynaecol 1985 Apr; 151(8):1142-3
28. Reece EA, Chervenak FA, Moya FR, Hobbins JC. Amniotic Fluid Arborization: effect of Blood, Meconium, and pH Alterations. Obstet Gynaecol 1984; 64: 248-250.
29. Rosemond RL, Lombardi SJ, Boehm FH. Ferning of Amniotic Fluid Contaminated with Blood. Obstet Gynaecol 1990; 75: 338-340.
30. Smith RP. A Technique for the Detection of Rupture of the Membranes:
A Review and Preliminary Report. Obstet Gynecol 1976; 48:172-176
68 31. de Hann HH, Offermans PM, Smits F, Schouten HJ, Peeters LL. Value of the Fern Test to Confirm or Reject the Diagnosis of Ruptured Membranes in Modest in Nonlabouring Women Presenting with Nonspecific Vaginal Fluid Loss. Am J Perinat. 1994 Jan; 11(1):46-50.
32. Gaucherand P, Salle B, Sergeant P, Guibaud S, Brun J, Bizollon CA, Rudigoz RC. Comparative Study of Three Vaginal Markers of the Premature Rupture of Membranes. Insulin like Growth Factor Binding Protein-1, diamine-oxidase, and PH. Acta Obstet Gynaecol Scand.1997 Jul; 76(6):536-40.
33. Aboyeji AP, Abdul IF, Ijaiya MA, Nwabuisi C, Ologe MO. The Bacteriology of Pre-labour Rupture of Membranes in a Nigerian Teaching Hospital, Journal Obstet Gynaecol, 2005 Nov; 25(8):761-4.
34. Caughey AB, Robinson JN, Norwitz ER. Contemporary Diagnosis and Management of Preterm Premature Rupture of Membranes. Rev Obstet Gynaecol. 2008 winter; 1(1):11-22.
35. Ajayi GO. Ultrasonography-guided Amniocentesis in Singleton Pregnancies: A Review of the First 1,000 Cases. Clin Exp Obstet Gynaecol. 2011; 38(4):405-7.
36. Aziken ME, Okpere EE. Premature Rupture of Membranes. In: Okpere EE (ed). Clinical Obstetrics. Revised Edition. Uniben Press, Benin City;
2004: 174-177.
37. Jazayeri A. Premature Rupture of Membranes. eMedicine Specialties, Obstetrics and Gynaecology; Obstetrical Complications. Updated: May 7, 2010.
69 38. Ikpeze OC. Preterm Delivery. In: Ikpeze OC (ed). Fundamental Obstetrics and Gynaecology.1st Edition. Africana First Publishers Plc, Onitsha;
2009: 23-27.
39. Li HY, Chang TS. Vaginal Fluid Creatinine, Human Chorionic Gonadotropin and Alpha-fetoprotein Levels for Detecting Premature Rupture of Membranes. Zhonghua Yi Xue Za Zhi (Taipei). 2000 Sep;
63:686–690.
40. Shahin M, Raslan H. Comparative Study of Three Amniotic Fluid Markers in Premature Rupture of Membranes: Prolactin, Beta subunit of Human Chorionic Gonadotropin, and Alpha-fetoprotein. Gynaecol Obstet Invest. 2007; 63:195–199.
41. Lockwood CJ, Senyei AE, Dische MR, Casal D, Shah KD, Thung SN, Jones L, Deligdisch L, Garite TJ. Fetal Fibronectin in Cervical and Vaginal Secretions Defines a Patient Population at high risk for preterm delivery. N Engl J Med. 1991 Sep 5; 325(10): 669–674.
42. Adeniji AO, Olayemi O, Odukogbe AA, Oladokun A, Adeniji OI, Egbewale BE, Omigbodun AO. Cervico-vaginal Foetal Fibronectin: A Predictor of Cervical Response at Pre-induction Cervical Ripening. West Afr J Med.
2005 Oct-Dec; 24(4):334-7.
43. Jeurgens-Borst AJ, Bekkers RL, Sporken JM, van der Berg PP. Use of Insulin like Growth Factor Binding Protein-1 in the Diagnosis of Ruptured Fetal Membranes. Eur J Obstet Gynecol Reprod Biol. 2002;
102:11–14.
44. Buyukbayrak EE, Turan C, Unal O, Dansuk R, Cengizoglu B. Diagnostic Power of the Vaginal Washing-fluid Prolactin Assay as an Alternative
70 Method for the Diagnosis of Premature Rupture of Membranes. J Matern Fetal Neonatal Med. 2004; 15:120–125.
45. Kim YH, Park YW, Kwon HS, Kwon JY, Kim BJ. Vaginal Fluid Beta-Human Chorionic Gonadotropin Level in the Diagnosis of Premature Rupture of Membranes. Acta Obstet Gynaecol Scand. 2005 Aug;
84(8):802–805.
46. Kafali H, Oksuzler C. Vaginal Fluid Urea and Creatinine in Diagnosis of Premature Rupture of Membranes. Arch Gynaecol Obstet. 2007;275:157–
160
47. Wiberg-Itzel E, Cnattingius S, Nordstrom L. Lactate Determination in Vaginal Fluids: A New Method in the Diagnosis of Prelabour Rupture of Membranes. Br J Obstet Gynaecol. 2005; 112:754–758.
48. Ni CY, Jia WX, Yi WM, Feng LH, Yu LZ. Practicability of Using Vaginal Fluid Markers in Detecting Premature Rupture of Membranes. Ann Clin Biochem. 2003 Sep; 40(5):542-5.
49. Gaucherand P, Guibaud S, Awada A, Rudigoz RC. Comparative Study of Three Amniotic Fluid Markers in Premature Rupture of Membranes:
Fetal Fibronectin, Alpha-fetoprotein, Diamino-oxydase. Acta Obstet Gynecol Scand. 1995 Feb; 74(2):118-21.
50. Garite TJ, Gocke SE. Diagnosis of Preterm Rupture of Membranes: Is Testing for Alpha-fetoprotein better than Ferning or Nitrazine? Am J Perinatol. 1990 Jul; 7(3):276-8.
51. Bennett SL, Cullen JB, Sherer DM, Woods JR Jr. The Ferning and Nitrazine Tests of Amniotic Fluid between 12 and 41 Weeks Gestation.
Am J Perinatol. 1993 Mar; 10(2):101-4.
71 52. Erdemoglu E, Mungan T. Significance of Detecting Insulin-like Growth Factor Binding Protein-1 in Cervicovaginal Secretions: Comparison with Nitrazine Test and Amniotic Fluid Volume Assessment. Acta Obstetricia et Gynaecologica Scandinavica. 2004; 83(7):622-626.
53. Petrunin DD, Griaznova IM, Petrunina IuA, Tatarinov IuS.
Immunochemical Identification of Organ Specific Human Placental Alpha-1 Globulin and Its Concentration in Amniotic Fluid. Akush Ginekol (Mosk), 1977; 1:64–65.
54. Chen FC, Dudenhausen JW. Comparison of Two Rapid Strip Tests Based on IGFBP-1 and PAMG-1 for the Detection of Amniotic Fluid. Am J Perinatol. 2008; 25(4):243-246.
55. Duff P. Preterm Premature Rupture of Membranes. UpToDate [online serial]. Waltham, MA: UpToDate; 2009.
56. Lee SM, Lee J, Seong HS, Lee SE, Park JS, Romero R, Yoon BH. The Clinical Significance of a Positive AmniSure Test in Women with Term Labour with Intact Membranes. J Matern Fetal Neonatal Med. 2009 Apr;
22(4):305-310.
57. Araoye MO. Subject Selection and Sample Size Determination. In: Araoye MO (ed). Research Methodology with Statistics for Health and Social Sciences. Nathadex Publishers; 2003:115-20.
58. pH Testing; Nitrazine Paper. The John Hopkins Hospital Point-of –Care
Testing ProgrammeSelf-studyPacket.Availableat:
http://pathology.jhu.edu/department/staff/POCT/SelfStudy/Nitrazine.p df. Accessed on 7th February, 2012.
72 59. Sauvaget C , Fayette J, Muwonge R, Wesley R, Sankaranarayanan R.
Accuracy of Visual Inspection with Acetic Acid for Cervical Cancer Screening. Int J Gynaecol Obstetrics, 2011 April; 113 (1): 14–24
60. Mulhair L, Carter J, Poston L, Seed P, Briley A. Prospective Cohort Study Investigating the Reliability of the AmnioSense Method for Detection of Spontaneous Rupture of Membranes. BJOG, July 2008; 116(2): 313-318.
61. Ajayi GO. Prenatal Diagnosis and Therapy. In: Okonofua F, Odunsi K (Eds). Contemporary Obstetrics and Gynaecology for Developing Countries. Women’s Health and Action Research Centre, 2003: 387-408.
62. Birkenmaier A, Ries JJ, Kuhle J, Bürki N, Lapaire O, Hösli I. Placental α-microglobulin-1 to Detect Uncertain Rupture of Membranes in a European Cohort of Pregnancies. Arch Gynaecol Obstet. 2012 Jan;
285(1):21-5.
63. Phupong V, Sonthirathi V. Placental Alpha-microglobulin-1 rapid Immunoassay for Detection of Premature Rupture of Membranes. J.
Obstet. Gynaecol. Res, January 2012; 38(1): 226–230.
64. Neil PR, Wallace EM. Is Amnisure® Useful in the Management of Women with Prelabour Rupture of the Membranes? Aust N Z J Obstet Gynaecol.
2010 Dec; 50(6):534-8.
65. Pollet-Villard M, Cartier R, Gaucherand P, Doret M. Detection of Placental Alpha Microglobulin-1 versus Insulin-like Growth Factor-binding Protein-1 in Amniotic Fluid at Term: A Comparative Study. Am J Perinatol. 2011 Jun; 28(6):489-94.
66. Knapik D, Olejek A. Analysis of Cervicovaginal Fluid in the Diagnosis of Premature Rupture of Membranes. Ginekol Pol. 2011 Jan; 82(1):50-5.