Characteristic of studies on test accuracy ...

Garite TJ, Casal D, Garcia-Alonso A, Kreaden U, Jimenez G, Ayala JA, et al. Fetal fibronectin: a new tool for the prediction of successful induction of labor. Am J Obstet Gynecol 1996;175:1516-21.

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;74:118-21.

Goepfert AR, Goldenberg RL, Andrews WW, Hauth JC, Mercer B, Iams J, et al. The Preterm Prediction Study: association between cervical interleukin 6 concentration and spontaneous preterm birth. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Am J Obstet Gynecol 2001;184:483-8.

Goldenberg RL, Thom E, Moawad AH, Johnson F, Roberts J, Caritis SN. The preterm prediction study: Fetal fibronectin, bacterial vaginosis, and peripartum infection. Obstet Gynecol 1996;87:656-60.

Hampel DJ, Kottgen B, Dudenhausen JW, Kottgen E. Fetal fibronectin as a marker for an imminent (preterm) delivery. A new technique using the glycoprotein lectin immunosorbent assay. J Immunol Methods 1999;224:31-42.

Joffe GM, Jacques D, Bernis HR, Burton R, Sicram B, Shelburne P. Impact of the fetal fibronectin assay on admissions for preterm labor. Am J Obstet Gynecol 1999;180:581-6.

Jones G, Elkington N. Fetal fibronectin and placental abruption. J Obstet Gynaecol 1999;19:535-6.

Lorenz EG, Weiss PAM, Haas J, Purstner P, Aderwohrer NE. Premature delivery and fetal fibronectin in the cervical and vaginal secretion. Geburtshilfe Frauenheilkd 1994;54:414-6.

Novakov MA, Ivanovic L, Nikolic A, Dukanac J, Crnogorac Z. [Levels of fetal fibronectin in the cervix and vagina during pregnancy] Koncentracija cervikovaginalnog fetalnog fibronektina tokom trudnoce. Med Pregl 1999;52:441-5.

Owen P, Scott A. Can fetal fibronectin testing improve the management of preterm labour? Clin Exp Obstet Gynecol 1997;24:19-22.

Pastore LM, Royce RA, Jackson TP, Thorp-JM J, Savitz DA, Kreaden US. Association between bacterial vaginosis and fetal fibronectin at 24-29 weeks' gestation. Obstet Gynecol 1999;93:117-23.

Perin A, Beltrame G, Marcon G, Mazzanti F. Fetal fibronectin measured in cervicovaginal secretions in physiological preterm pregnancies: relation with the delivery. Eur J Lab Med 1997;5:35-8.

Shimoya K, Hashimoto K, Shimizu T, Saji F, Murata Y. Effect of sexual intercourse on fetal fibronectin concentration in cervicovaginal secretions. Am J Obstet Gynecol 1998;179:255-6.

Trovo S, Brigato L, Plebani M, Brigato G, Grismondi GL. [Premature membrane rupture. Comparison of diagnostic tests] Rottura intempestiva delle membrane. Test diagnostici a confronto. Minerva Ginecol 1998;50:519-22.

Zygmunt M, Lang U, Katz N, Kunzel W. Maternal plasma fibronectin: a predictor of preterm delivery. Eur J Obstet Gynecol Reprod Biol 1997;72:121-6.

Duplicate publications or more complete datasets available elsewhere

Burrus DR, Ernest JM, Veille JC. Efficacy of four markers of preterm labor (PTL) at predicting preterm delivery (PTD) in a population presenting with contractions and cervical change. Am J Obstet Gynecol 1995;172:405.

Chien PFW, Khan KS, Ogston S, Owen P. How useful is cervico-vaginal fetal fibronectin in predicting preterm labour�evidence from an overview. J Obstet Gynaecol 1998;18:95.

Goepfert AR, Goldenberg RL, Mercer B, Iams J, Meis P, Moawad A, et al. The preterm prediction study: quantitative fetal fibronectin values and the prediction of spontaneous preterm birth. The National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Am J Obstet Gynecol 2000;183:1480-3.

Goldenberg RL, Iams JD, Das A, Mercer BM, Meis PJ, Moawad AH, et al. The preterm prediction study: Sequential cervical length and fetal fibronectin testing for the prediction of spontaneous preterm birth. Am J Obstet Gynecol 2000;182:636-43.

Hellemans P, Gerris J, Verdonk P. Foetal fibronectin as a predictor of preterm birth in low-risk women. Tijdschr Fertil 1996;10:36-9.

Morrison JC, Naef RW, Botti JJ, Belluomini JM. Uterine activity and fetal fibronectin are independent and combined predictors of spontaneous preterm birth. Am J Obstet Gynecol 1995;172:406.

Oliveira TA, Carvalho CM, de Souza E, Mariani NC, Camano L. Detection of fetal fibronectin in twin pregnancies in relation to gestational age. Sao Paulo Med J 1999;117:121-4.

Owen P. Fetal fibronectin detection for prediction of preterm birth in low risk women. Br J Obstet Gynaecol 1995;102:1019.

Rozenberg P, Nisand I, Malagrida L, Vayssiere C, Goffinet F, Philippe HJ, et al. Rational use for fetal fibronectin in the assessment of premature delivery risk. J Gynecol Obstet Biol Reprod 1996;25:288-93.

Not enough data to construct 2´ 2 table

Iams JD, Goldenberg RL, Mercer BM, Moawad A, Thom E, Meis PJ, et al. The preterm prediction study: recurrence risk of spontaneous preterm birth. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Am J Obstet Gynecol 1998;178:1035-40.

Klosek A, Hirnle L, Zimmer M, Tomialowicz M, Zmijewski J, Fuchs T, et al. [Fibronectin level in amniotic fluid as an index of unavoidable labor] Stezenie fibronektyny w plynie owodniowym jako wykladnik nieuchronnego porodu. Ginecologica Polska 2000;71:298-303.

O'Brien JM, Mercer B, Pitts DW, Sibai BM. A comparison of fetal fibronectin, prolactin, and cervical examination for the prediction of preterm delivery in symptomatic patients. Am J Obstet Gynecol 1995;172:406.

Skalba P, Kaminski K, Bilski T. [Fetal fibronectin as a predictor of threatening preterm delivery] Fibronektyna plodowa jako wskaznik zagrazajacego porodu przedwczesnego. Przeglad Lekarski 1992;49:350-1.

Watson DL, Kim SJ, Humphrey MD. Study of cervicovaginal fetal fibronectin status to guide treatment of threatened preterm labour. Aust N Z J Obstet Gynaecol 1998;38:185-7.

Lack of original data (for example, reviews, letter, editorial, etc)

Ascarelli MH, Morrison JC. Use of fetal fibronectin in clinical practice. Obstet Gynecol Surv 1997;52:S1-11.

Bon C, Roubille M, Mailliavin A, Pichot J. Fetal fibronectin detection for prediction of preterm delivery. Immuno Anal Biol Spec 2000;15:96-108.

Chien PFW, Khan KS, Ogston S, Owen P. The diagnostic accuracy of cervico-vaginal fetal fibronectin in predicting preterm delivery: an overview. Br J Obstet Gynaecol 1997;104:436-44.

Daskalakis GJ, Papantoniou NE, Koutsodimas NB, Papapanagiotou A, Antsaklis AJ. Fetal fibronectin as a predictor of preterm birth. J Obstet Gynaecol 2000;20:347-53.

Faron G, Boulvain M, Irion O, Bernard PM, Fraser WD. Prediction of preterm delivery by fetal fibronectin: a meta-analysis. Obstet Gynecol 1998;92:153-8.

Feinberg RF, Kliman HJ, Sadovsky Y, Friedman SA, Lockwood CJ, Senyei AE, et al. Fetal fibronectin and preterm labor [[2]]. N Engl J Med 1992;326:708-9.

Fetal fibronectin measurement to predict preterm delivery. Am Fam Phys 1992;45:287.

Fetal fibronectin preterm labor risk test. Int J Gynecol Obstet 1997;59:164.

French L. Fetal fibronectin to predict preterm delivery. J Fam Pract 1998;47:250-1.

Jones G, Poston L, Chien P, Khan K. The diagnostic accuracy of cervico-vaginal fetal fibronectin in predicting preterm delivery: an overview [[4]] (multiple letters). Br J Obstet Gynaecol 1998;105:244-5.

Leeson S, Maresh M. Fibronectin: a predictor of preterm delivery? Br J Obstet Gynaecol 1993;100:304-6.

Leeson S, Maresh MJ. Predicting preterm delivery: the fetal fibronectin test. Prof Care Mother Child 1994;4:38-9.

Leitich H, Egarter C, Kaider A, Hohlagschwandtner M, Berghammer P, Husslein P. Cervicovaginal fetal fibronectin as a marker for preterm delivery: a meta-analysis. Am J Obstet Gynecol 1999;180:1169-76.

McParland PC, Bell SC, Malak TM, Taylor DJ. Fibronectin in cervicovaginal secretions in the prediction of preterm birth. Contemp Rev Obstet Gynaecol 1997;9:33-41.

Morrison JJ, Thornton S, Leeson S, Maresh M. Fibronectin: a predictor of preterm delivery? [[1]]. Br J Obstet Gynaecol 1993;100:969.

Plaut M, Iams JD. Fetal fibronectin and the safety of outpatient management for preterm labor symptoms [[3]]. Am J Obstet Gynecol 1996;174:797-8.

Rehbock J, Gloning KP. [Fetal fibronectin as a predictive factor of threatened premature labor] Fetales Fibronektin als pradiktiver Faktor der drohenden Fruhgeburt. Gynakol Geburtshilfliche Rundsch 1993;33(suppl 1):191-2.

Revah A, Hannah ME, Sue Aq-A. Fetal fibronectin as a predictor of preterm birth: an overview. Am J Perinatol 1998;15:613-21.

Sadovsky Y,.Friedman SA. Fetal fibronectin and preterm labor [[letter; comment]]. N Engl J Med 1992;326:709.

Tchobroutsky C. [Fetal fibronectin in cervico-vaginal secretions: prediction of premature and term delivery] La fibronectine foetale dans les secretions cervico-vaginales: prediction de l'accouchement premature et a terme. Contracept Fertil Sex 1998;26:23-5.

Velasco JG, Gonzalez GA. [[Fibronectin and prevention of premature labor (editorial)]] Fibronectina y prevencion del parto pretermino. Med Clin Barc 1995;105:54-5.

Wiqvist N. Fetal fibronectin and preterm birth. Acta Obstet Gynecol Scand 1993;72:507-8.

Unobtainable

Gaucherand P. La fibronectine: nouveau marqueur de la menace d'accouchement premature. J Obstet Gynaecol 1995;3:17-20.

Ichijo M, Satoh K, Nozawa S, Takagi K, Terao T, Hashimoto H, Tsubata K, et al. [[Clinical significance of oncofetal fibronectin in vaginal secretions for diagnosis of preterm delivery]]. Sanfujika Chiryo 1993;67:212-8.

Characteristic of studies on test accuracy of cervicovaginal fetal fibronectin in predicting spontaneous preterm birth

Study	Language	Quality of study*	No of women	Inclusion criteria	Exclusion criteria	Gestation at testing (weeks)	Type and frequency of test	Swab site	Cut off (ng/ml)	Outcome
Asymptomatic� and high risk�
Goldenberg 1996³⁹	English	Blind; consecutive; prospective; test described	147	Twins	Cerclage. Placenta previa. Fetal anomaly	22, 24, 26, 28, 30	Elisa: multiple, twice weekly	Fornix, cervix	50	<32 , <35, and <37 weeks
Morrison 1996⁴⁰	English	Blind; consecutive; prospective; test described	85	Intact membrane. Multiple gestations, or singletons with history of spontaneous preterm birth, uterine anomalies, recurrent 2nd trimester miscarriage	Cerclage, threatened preterm labour, vaginal bleeding, serious maternal and fetal condition	22-32	Elisa, multiple, once-twice weekly	Ectocervix	50	<34 weeks
Tolino 1996⁴¹	English	Blind; consecutive; prospective; test described	68	Multiple gestation	None stated	24-36	Bedside, multiple, weekly	Fornix, ectocervix	50	<37 weeks
Bittar 1996²³	English	Consecutive; prospective; test described	102	Singleton pregnancies. Intact membrane, spontaneous preterm birth, cerclage in current pregnancy, uterine malformation	Vaginal bleeding. Coitus <24 hrs. Fetal anomaly	24-34	Bedside Elisa, multiple, twice weekly	Ectocervix	50	<37 weeks
Leeson 1996⁶¹	English	Blind; prospective; test described	40	Intact membrane, history of spontaneous preterm birth or current multiple gestation	None stated	24-34	Elisa, multiple, twice weekly	Fornix	50	<37 weeks
Nageotte 1994⁶⁶	English	Blind; prospective; test described	87	Intact membrane. Undilated cervix. Uterine malformation, cerclage, or multiple gestation. Previous history of spontaneous preterm birth	Candida infection	24-34	Elisa, multiple weekly	Fornix, ectocervix	50	<37 weeks
Oliveira 1998^67;68	English	Blind; prospective; test described	52	Twins. Undilated cervix and cervical length >1cm	Vaginal bleeding. Iatrogenic preterm delivery. Disagreement between two observers to result of test	24-34	Bedside, multiple, twice weekly	Not stated	50	<34 and <37 weeks
Krems 1995⁶⁹(Abstract)	English	Blind; test described	26	History of spontaneous preterm birth, premature labour, preterm premature rupture of membrane, and stillbirth	None stated	>24	Elisa, multiple, weekly	Cervix	50	<36 weeks
Nageotte 1992⁷⁰(Abstract)	English	Test described	102	Multiple gestation. Uterine anomaly. Previous history of spontaneous preterm birth and cervical incompetence	None stated	>20	Elisa, multiple, twice weekly	Fornix	50	<34 and <37 weeks
Asymptomatic� and low risk
Faron 1997⁴²	English	Blind; consecutive; prospective; test described	155	All asymptomatic women in antenatal clinic with known gestation	Vaginal bleeding	24-33	Elisa, single	Endocervix	50	<37 weeks
Hellemans 1995⁴³	English	Blind; consecutive; prospective; test described	133	Low risk singletons pregnancies. Intact membrane	Placenta previa. Vaginal bleeding. Cervical dilatation >1cm or cervical cerclage. Threatened preterm labour <26 weeks, unknown date	26-36	Elisa, multiple twice weekly	Ectocervix	50	<37 weeks
Chang 1997²⁵	English	Blind; prospective; test described	234	Singletons pregnancies in women without history of spontaneous preterm labour or birth. Intact membrane	Vaginal bleeding. Pre-eclampsia. Placenta previa. Uncertain date. Fetal anomaly	28	Elisa, single	Fornix	50	<34 and <37 weeks
Garcia 1999⁷¹	Spanish	Blind; prospective; test described	263	Low risk singletons. Intact membrane	Cerclage	24-37	Elisa, single	Fornix	50	<32 and <37 weeks
Greenhagen 1996⁷²	English	Blind; prospective; test described	108	Low risk singletons pregnancies. Intact membrane	Previous history of spontaneous preterm labour or birth. Vaginal bleeding. Fetal anomaly	24-34	Elisa, multiple, twice weekly	Fornix	50	<37 weeks
Di Stefano 1999²⁷	English	Prospective; test described	60	Singletons pregnancies. Intact membrane	Previous history of spontaneous preterm labour or birth. Vaginal bleeding. Fetal anomaly. Cervical cerclage. Genital infection. Maternal or fetal complications during gestation &/or examination	24-36	Elisa, multiple, twice weekly	Fornix, ectocervix	50	<37 weeks
Gebhardt 1995⁵³	English	Blind; test described	18	Low risk primigravidas	None stated	28-32	Elisa, single	Fornix, ectocervix	1000	<34 weeks
Zamora 2000⁷³	Spanish	Blind; test described	20	Asymptomatic pregnant women. Intact membrane	Coitus <24 hours. Recent use of vaginal pessary	28-36	Elisa, single	Ectocervix	50	<37 weeks
Asymptomatic,� risk unclassified
Crane 1999⁴⁴	English	Blind; consecutive; prospective; test described	140	Singleton pregnancies. Intact membrane	Cerclage. Fetal anomalies or death. Vaginal bleeding. Recently treated bacterial vaginosis	20-24	Elisa, single	Fornix, cervix	50	<37 weeks
Heath 2000⁴⁵	English	Blind; consecutive; prospective; test described	5146	Singletons pregnancies of women attending inner city antenatal clinic	Fetal abnormalities	22-24	Elisa, single	Fornix	50	<33 weeks
Arinami 1999⁷⁴	English	Consecutive; prospective; test described	438	Singleton pregnancies without medical or obstetric complications	None stated	26-28	Elisa, single	Not stated	50	<34 and <37 weeks
Goldenberg 1996⁷⁵	English	Blind; prospective; test described	2929	Singletons pregnancies	Placenta previa. Fetal anomalies	22, 24, 26, 28, 30	Elisa, multiple, twice weekly	Fornix, cervix	50	<34 weeks
Goldenberg 1997⁷⁶	English	Blind; prospective; test described	1870	Singleton pregnancies of women not randomised to treatment for Trichomonas vaginales or bacterial vaginosis	None stated	8-22	Elisa, single	Fornix	50	<35 weeks
Goldenberg 2000⁷⁷	English	Blind; prospective; test described	6508	Singletons pregnancies	None stated	8-22	Elisa, single	Fornix	50	<28, <32, <35, <37 weeks
Hux 1995⁷⁸	English	Blind; prospective; test described	54	Intact membrane and undilated cervix	Candida infection, fetal anomalies, vaginal bleeding, placenta previa, and threatened preterm labour	26-29	Elisa, single	Lower 3rd of vagina	50	<37 weeks
Inglis 1994⁷⁹	English	Blind; prospective; test described	73	Intact membrane	Fetal anomalies, placenta previa, genital or urinary infection, use of antibiotics in the preceding 7 days	<37	Elisa, single	Fornix, endocervix	50	<37 weeks
Lockwood 1993⁸⁰	English	Blind; prospective; test described	429	Asymptomatic women from inner city antenatal clinic	Uncertain date, placenta previa, iatrogenic preterm delivery	24-37	Elisa, multiple, twice weekly	Cervix, vagina	>50 vagina, >60 cervix	<28 day, <37 weeks
Goldenberg 1997⁷⁶	English	Prospective; test described	2929	Singletons pregnancies	Placenta previa. Fetal anomalies	22, 24, 26, 28, 30	Elisa, multiple, twice weekly	Fornix, cervix	50	<35 and <37 weeks
Vercoustre 1996⁸¹	French	Test described	58	None stated	Coitus <24 hours and vaginal bleeding	27-37	Elisa, single, multiple	Fornix, ectocervix	50	<37 weeks
Symptomatic¶ and high risk
Malagrida 1995⁸²	French	Blind; prospective; test described	105	Intact membrane, twins, cervical changes, uterine malformation, cerclage	Psychiatric condition, coitus <24 hours	24-34	Bedside, single	Fornix	50	<37 weeks
Surbek 1997⁸³	German	Blind; prospective; test described	56	Multiple gestation, uterine malformation, urogenital infection, vaginal bleeding, history of spontaneous preterm birth	Preterm premature rupture of membrane. Placenta previa. Unknown date	24-32	Elisa, single	Fornix	50	<37 weeks
Zamora 2000⁷³	Spanish	Blind; test described	22	Threatened preterm labour. Intact membrane	Coitus <24 hours. Recent use of vaginal pessary	28-36	Elisa, single	Ectocervix	50	<37 weeks
Roubille 1999⁸⁴	French	Test described	188	Intact membrane and requiring hospital admission	Placenta previa, fetal anomalies, fetal distress, intrauterine growth retardation, and vaginal infection	23-35	Bedside, single	Fornix, ectocervix	50	<37 weeks
Symptomatic¶ and low risk
Bartnicki 1996²¹	English	Blind; prospective; test described	112	Intact membrane, cervical dilatation <2 cm	None stated	22-35	Elisa, single	Fornix	50	<7, <14, <21, and <28 days and <34 weeks
Benattar 1997²²	English	Blind; prospective; test described	124	Singletons and twin pregnancies. Intact membrane, cervical dilatation <3 cm	Vaginal bleeding. Coitus <24 hours	24-36	Bedside, single	Fornix, ectocervix	50	<7, <14, <21, and days and <32 and <34 weeks
Calda 1995⁸⁵	Czech	Prospective; test described	84	Intact membrane	None stated	24-34	Bedside, single	Fornix	50	<36 weeks
Gebhardt 1995⁵³	English	Blind; test described	11	Symptomatic women in first pregnancies. Intact membrane	None stated	28-36	Elisa, single	Fornix, ectocervix	1000	<37 weeks
Hampl 1994⁵⁴	German	Prospective; test described	34	Intact membrane	Fetal anomaly and cervical cerclage	24-36	Elisa, single, multiple	Fornix	75	<37 weeks
Symptomatic,¶ risk unclassified
Coleman 1998⁴⁶	English	Blind; consecutive; prospective; test described	121	Intact membrane. Cervical dilatation <3 cm. Singletons, twins, and one triplet pregnancy	Vaginal bleeding. Placenta previa. Coitus <24 hours	24-34	Bedside, single	Fornix	50	<10 days
Coleman 2001⁴⁷	English	Blind; consecutive; prospective; test described	104	Intact membrane. Cervical dilatation <3 cm	Vaginal bleeding. Placenta previa. Coitus <24 hours	24-34	Elisa, single	Fornix	50	<48 hours, <7 days
Grandi 1996⁴⁸	Spanish	Blind; consecutive; prospective; test described	26	Singletons pregnancies. Intact membrane. Cervical dilation <2 cm	Placenta previa. Placental abruption. Fetal anomalies. Coitus <24 hours, iatrogenic preterm labour	24-36	Elisa, single	Cervix	50	<37 weeks
La Shay 2000⁵¹	English	Blind; consecutive; prospective; test described	118	Singleton pregnancies. Intact membrane. Cervical dilatation <3 cm	Coitus or digital vaginal examination within 24 hours. Vaginal bleeding. Placenta previa. Placental abruption. Polyhydramnios. Pre-eclampsia. Known uterine or fetal abnormalities	24-34	Elisa, single	Fornix, endocervix	50	<48 hours, 7 days, 37 weeks
Morrison 1993⁴⁹	English	Blind; consecutive; prospective; test described	28	Singleton pregnancies. Intact membrane	Uterine or cervical abnormalities. Vaginal bleeding. Placenta previa. Suspected placental abruption. Coitus or douching <24 hours. Diabetes mellitus. Unknown date. Pre-eclampsia.<15 years old	24-34	Elisa, single	Ectocervix	50	<37 weeks
Senden 1996⁵⁰	English	Blind; consecutive; prospective; test described	25	Singleton pregnancies. Intact membrane. Cervical dilatation <4 cm	Vaginal bleeding. Clinical chorioamnionitis. Diabetes mellitus	25-35	Bedside, single	Fornix	50	<7 days
Burrus 1995⁸⁶	English	Blind; prospective; test described	37	Symptomatic women in first pregnancy. Intact membrane. Cervical dilatation <3 cm and changing, no contraindication to tocolytic	Amnionitis. Placental abruption	<34	Elisa, single	Not stated	50	<37 weeks
Goffeng 1997⁸⁷	English	Consecutive; prospective; test described	63	Singletons pregnancies with intact membrane	Pre-eclampsia. Uterine or cervical abnormalities. Placenta previa, placental abruption. Fetal anomalies. Diabetes mellitus	23-34	Elisa, single	Fornix	50	<34 and <37 weeks
Iams 1995⁶⁰	English	Blind; prospective; test described	192	Intact membrane. Cervical dilation <3 cm	Placenta previa. Cerclage. Uterine anomalies. Vaginal bleeding	24-34	Elisa, single	Fornix, ectocervix	50	<7 days, <37 weeks
Inglis 1994⁷⁹	English	Blind; prospective; test described	38	Singletons pregnancies. Intact membrane	Fetal anomalies. Placenta previa. Genital or urinary infection. Use of antibiotics in the preceding 7 days	<37	Elisa, single	Fornix, endocervix	50	<37 weeks
Irion 1995⁸⁸	French	Blind; prospective; test described	64	Intact membrane. Cervical dilation <2 cm	Fetal anomalies. Vaginal bleeding. Coitus <24 hours. Iatrogenic preterm delivery	24-36	Elisa, single	Endocervix	50	<37 weeks
Langer 1997⁸⁹	English	Blind; prospective; test described	61	Intact membrane	Vaginal bleeding. Coitus <24 hours. Progressive cervical dilatation. Abnormal fetal heart rate monitoring	24-34	Elisa, single	Endocervix, ectocervix	50	<37 weeks
Lockwood 1991⁸	English	Blind; prospective; test described	117	Intact membrane	Fetal anomalies. Placenta previa. Coitus <24 hours. Intrauterine growth restriction. Fetal distress. Previous pregnancy terminated due to severe pre-eclampsia	25-35	Elisa, single	Fornix, cervix	50	<37 weeks
Lukes 1997⁶²	English	Blind; prospective; test described	763	Intact membrane. Cervical dilation <2 cm	None stated	24-34	Elisa, single	Fornix	50	<7 days
Luo 1997⁵²	Chinese	Consecutive; prospective; test described	38	Intact membrane	Vaginal bleeding. Placental abruption	28-36	Elisa, single	Cervix	250	<37 weeks
Malak 1996⁶³	English	Blind; prospective; test described	112	Singletons pregnancies. Intact membrane. Cervical dilation <2 cm	Placenta previa. Vaginal bleeding. Coitus <24 hours	24-34	Elisa, single	Fornix, ectocervix	50	<7, <14, and <21 days, <37 weeks
McKenna 1999⁶⁴	English	Consecutive; prospective; test described	50	Cervical dilation <3 cm	Coitus <24 hours. Vaginal digital examination or transvaginal ultrasonography. Cerclage. Uterine anomalies. Placenta previa. Placental abruption	22-34	Elisa, double, one before VE, one after VE	Ectocervix, fornix	50	<7 and <14 days, <37 weeks
Parker 1995⁹⁰	English	Blind; prospective; test described	36	Singletons pregnancies. Intact membrane. Cervical dilation <2 cm	Placenta previa. Placental abruption. Cerclage. Fetal anomalies. Coitus <24 hours	20-34	Bedside, single	Fornix, ectocervix	50	<34 weeks
Peaceman 1997⁶⁵	English	Blind; prospective; test described	725	Singleton, twin pregnancies, and one triplet. Intact membrane. Cervical dilatation <3 cm	Placenta previa. Cerclage. Trauma leading to preterm labour	24-34	Elisa, single	Fornix	50	<7 and <14 days, <37 weeks
Rizzo 1996⁹¹	English	Blind; prospective; test described	108	Singleton pregnancies. Intact membrane. Cervical dilatation <3 cm	Fetal or maternal complication	24-34	Elisa, single	Fornix, ectocervix	50 fornix, 60 vagina	<37 weeks
Rizzo 1997⁹²	English	Blind; prospective; test described	106	Singleton pregnancies. Intact membrane. Cervical dilatation <3 cm	Fetal or maternal complications. Urinary or genital infection. Use of antibiotic in the preceding 14 days	24-36	Bedside, single	Fornix, ectocervix	50	<37 weeks
Rozenberg 1997⁹³	English	Blind; prospective; test described	76	Singleton pregnancies. Intact membrane. Cervical dilatation <2 cm	Gestation <24 or >34 weeks. Cerclage. Placenta previa. Placental abruption. Iatrogenic preterm delivery	24-34	Elisa, single	Fornix	50	<37 weeks
Wennerholm 1997⁹⁴	English	Blind; prospective; test described	101	Twin pregnancies. Intact membrane	Coitus <24 hours. Vaginal bleeding	24-34	Elisa, multiple, twice weekly	Fornix, cervix	50	<34 and <37 weeks
Chuileannain 1998⁹⁵	English	Retrospective; test described	50	Singletons pregnancies. Intact membrane. Cervical dilation <2 cm	Placenta previa. Placental abruption. Cerclage. Fetal anomalies	<34	Bedside, single	Fornix, ectocervix	50	<34 weeks
Giles 2000⁵⁸	English	Prospective; test described	150	Intact membrane	Vaginal bleeding. Coitus <24 hours. Recent digital vaginal examination	24-34	Bedside, single	Not stated	50	<7 days, <36 weeks
Vetr 1996⁹⁶	English	Prospective; test described	46	Intact membrane	Fetal anomalies. Placenta previa. Vaginal bleeding. Intra-uterine growth restriction. Fetal distress. Diabetes mellitus. Pre-eclampsia	25-36	Bedside, single	Ectocervix	50	<37 weeks
Cox 1995⁹⁷(Abstract)	English	Test described	175	Intact membrane. Cervical dilatation <3 cm	None stated	24-34	Elisa, single	Fornix	50	<37 weeks
Mansouri 1996⁹⁸	French	Retrospective; test described	90	Intact membrane	Vaginal bleeding. Coitus <24 hours	24-34	Elisa, single	Fornix, ectocervix	50	<37 weeks
Patricot 1997⁹⁹	French	Test described	75	Symptomatic women with cervical changes and requiring tocolytics	None stated	28-35	Bedside Elisa, single	Fornix	50	<37 weeks
Vercoustre 1996⁸¹	French	Test described	86	Singleton and twin pregnancies	Coitus <24 hours. Vaginal bleeding	<37	Elisa, single, multiple	Fornix, ectocervix	50	<37 weeks
Lopez 2000⁵⁹	English	Retrospective	85	Singletons pregnancies. Intact membrane. Cervical dilation <3 cm	Uncertain date. Lost to follow up. Incomplete data	24-35	Elisa, single, multiple	Not stated	Not stated	<7 and 14 days, <34 and <37 weeks

Elisa=enzyme linked immunosorbent assay.

*If quality item (that is, clinician blinded to result, consecutive population enrolments, prospective or retrospective study design or description of the test) is not stated, it was either not reported or was not explicitly clear.

�Asymptomatic population defined as pregnant women without uterine tightening or contractions.

�Risk classifications, if stated, were based on either clinical or historical factors as defined by study=s author(s)�for example, history of previous spontaneous preterm birth, history of recurrent miscarriages, multiple gestations, etc.

¶Symptomatic population defined as pregnant women with uterine tightening or contractions but without cervical dilatation of more than 2-3 cm.