Quantitative fetal fibronectin to predict preterm birth in asymptomatic women at high risk

Danielle S Abbott; Natasha L Hezelgrave; Paul T Seed; Jane E Norman; Anna L David; Phillip R Bennett; Joanna C Girling; Manju Chandirimani; Sarah J Stock; Jenny Carter; Ruth Cate; James Kurtzman; Rachel M Tribe; Andrew H Shennan

doi:10.1097/AOG.0000000000000754

Quantitative fetal fibronectin to predict preterm birth in asymptomatic women at high risk

Danielle S Abbott, Natasha L Hezelgrave, Paul T Seed, Jane E Norman, Anna L David, Phillip R Bennett, Joanna C Girling, Manju Chandirimani, Sarah J Stock, Jenny Carter, Ruth Cate, James Kurtzman, Rachel M Tribe, Andrew H Shennan

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Abstract

OBJECTIVE: To evaluate the diagnostic accuracy of cervicovaginal fluid quantitative fetal fibronectin, measured by a bedside analyzer, to predict spontaneous preterm birth before 34 weeks of gestation.

METHODS: We conducted a prospective masked observational cohort study of cervicovaginal fluid quantitative fetal fibronectin concentration in asymptomatic women at high risk of spontaneous preterm birth (n=1,448; 22-27 6/7 weeks of gestation) measured using a rapid bedside analyzer. The routine qualitative result (positive-negative) was made available to clinicians at the time of testing, but the quantitative result remained blinded until after delivery.

RESULTS: Spontaneous preterm birth (less than 34 weeks of gestation) increased from 2.7%, 11.0%, 14.9%, 33.9%, and 47.6% with increasing concentration of fetal fibronectin (less than 10, 10-49, 50-199, 200-499, and 500 ng/mL or greater, respectively). A threshold of 200 ng/mL had a positive predictive value of 37.7 (95% confidence interval [CI] 26.9-49.4) with specificity 96% (95% CI 95.3-97.3). Women with a fetal fibronectin concentration of less than 10 ng/mL had a very low risk of spontaneous preterm birth at less than 34 weeks of gestation (2.7%), no higher than the background spontaneous preterm birth rate of the general hospital population (3.3%). The quantitative fetal fibronectin test predicted birth at less than 34 weeks of gestation with an area under the curve (AUC) of 0.78 (95% CI 0.73-0.84) compared with the qualitative test AUC 0.68 (95% CI 0.63-0.73). Quantitative fetal fibronectin discriminated risk of spontaneous preterm birth at less than 34 weeks of gestation among women with a short cervix (less than 25 mm); 9.5% delivered prematurely less than 10 ng/mL compared with 55.1% greater than 200 ng/mL (P<.001).

DISCUSSION: Alternative risk thresholds (less than 10 ng/mL and greater than 200 ng/mL) improve accuracy when using quantitative fetal fibronectin measurements to define risk of spontaneous preterm birth. This is particularly relevant for asymptomatic women with a short cervix.

LEVEL OF EVIDENCE: II.

Original language	English
Pages (from-to)	1168-76
Number of pages	9
Journal	Obstetrics and Gynecology
Volume	125
Issue number	5
DOIs	https://doi.org/10.1097/AOG.0000000000000754
Publication status	Published - May 2015

Keywords

Adult
Area Under Curve
Asymptomatic Diseases
Cervix Uteri/diagnostic imaging
Female
Fetus/metabolism
Fibronectins/metabolism
Humans
Predictive Value of Tests
Premature Birth/diagnosis
Prospective Studies
Ultrasonography

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Abbott, D. S., Hezelgrave, N. L., Seed, P. T., Norman, J. E., David, A. L., Bennett, P. R., Girling, J. C., Chandirimani, M., Stock, S. J., Carter, J., Cate, R., Kurtzman, J., Tribe, R. M., & Shennan, A. H. (2015). Quantitative fetal fibronectin to predict preterm birth in asymptomatic women at high risk. Obstetrics and Gynecology, 125(5), 1168-76. https://doi.org/10.1097/AOG.0000000000000754

@article{705e2b4b4d234f529dd640f11718c0a9,

title = "Quantitative fetal fibronectin to predict preterm birth in asymptomatic women at high risk",

abstract = "OBJECTIVE: To evaluate the diagnostic accuracy of cervicovaginal fluid quantitative fetal fibronectin, measured by a bedside analyzer, to predict spontaneous preterm birth before 34 weeks of gestation.METHODS: We conducted a prospective masked observational cohort study of cervicovaginal fluid quantitative fetal fibronectin concentration in asymptomatic women at high risk of spontaneous preterm birth (n=1,448; 22-27 6/7 weeks of gestation) measured using a rapid bedside analyzer. The routine qualitative result (positive-negative) was made available to clinicians at the time of testing, but the quantitative result remained blinded until after delivery.RESULTS: Spontaneous preterm birth (less than 34 weeks of gestation) increased from 2.7\%, 11.0\%, 14.9\%, 33.9\%, and 47.6\% with increasing concentration of fetal fibronectin (less than 10, 10-49, 50-199, 200-499, and 500 ng/mL or greater, respectively). A threshold of 200 ng/mL had a positive predictive value of 37.7 (95\% confidence interval [CI] 26.9-49.4) with specificity 96\% (95\% CI 95.3-97.3). Women with a fetal fibronectin concentration of less than 10 ng/mL had a very low risk of spontaneous preterm birth at less than 34 weeks of gestation (2.7\%), no higher than the background spontaneous preterm birth rate of the general hospital population (3.3\%). The quantitative fetal fibronectin test predicted birth at less than 34 weeks of gestation with an area under the curve (AUC) of 0.78 (95\% CI 0.73-0.84) compared with the qualitative test AUC 0.68 (95\% CI 0.63-0.73). Quantitative fetal fibronectin discriminated risk of spontaneous preterm birth at less than 34 weeks of gestation among women with a short cervix (less than 25 mm); 9.5\% delivered prematurely less than 10 ng/mL compared with 55.1\% greater than 200 ng/mL (P<.001).DISCUSSION: Alternative risk thresholds (less than 10 ng/mL and greater than 200 ng/mL) improve accuracy when using quantitative fetal fibronectin measurements to define risk of spontaneous preterm birth. This is particularly relevant for asymptomatic women with a short cervix.LEVEL OF EVIDENCE: II.",

keywords = "Adult, Area Under Curve, Asymptomatic Diseases, Cervix Uteri/diagnostic imaging, Female, Fetus/metabolism, Fibronectins/metabolism, Humans, Predictive Value of Tests, Premature Birth/diagnosis, Prospective Studies, Ultrasonography",

author = "Abbott, \{Danielle S\} and Hezelgrave, \{Natasha L\} and Seed, \{Paul T\} and Norman, \{Jane E\} and David, \{Anna L\} and Bennett, \{Phillip R\} and Girling, \{Joanna C\} and Manju Chandirimani and Stock, \{Sarah J\} and Jenny Carter and Ruth Cate and James Kurtzman and Tribe, \{Rachel M\} and Shennan, \{Andrew H\}",

year = "2015",

month = may,

doi = "10.1097/AOG.0000000000000754",

language = "English",

volume = "125",

pages = "1168--76",

journal = "Obstetrics and Gynecology",

issn = "0029-7844",

publisher = "Lippincott Williams and Wilkins",

number = "5",

}

Abbott, DS, Hezelgrave, NL, Seed, PT, Norman, JE, David, AL, Bennett, PR, Girling, JC, Chandirimani, M, Stock, SJ, Carter, J, Cate, R, Kurtzman, J, Tribe, RM & Shennan, AH 2015, 'Quantitative fetal fibronectin to predict preterm birth in asymptomatic women at high risk', Obstetrics and Gynecology, vol. 125, no. 5, pp. 1168-76. https://doi.org/10.1097/AOG.0000000000000754

TY - JOUR

T1 - Quantitative fetal fibronectin to predict preterm birth in asymptomatic women at high risk

AU - Abbott, Danielle S

AU - Hezelgrave, Natasha L

AU - Seed, Paul T

AU - Norman, Jane E

AU - David, Anna L

AU - Bennett, Phillip R

AU - Girling, Joanna C

AU - Chandirimani, Manju

AU - Stock, Sarah J

AU - Carter, Jenny

AU - Cate, Ruth

AU - Kurtzman, James

AU - Tribe, Rachel M

AU - Shennan, Andrew H

PY - 2015/5

Y1 - 2015/5

N2 - OBJECTIVE: To evaluate the diagnostic accuracy of cervicovaginal fluid quantitative fetal fibronectin, measured by a bedside analyzer, to predict spontaneous preterm birth before 34 weeks of gestation.METHODS: We conducted a prospective masked observational cohort study of cervicovaginal fluid quantitative fetal fibronectin concentration in asymptomatic women at high risk of spontaneous preterm birth (n=1,448; 22-27 6/7 weeks of gestation) measured using a rapid bedside analyzer. The routine qualitative result (positive-negative) was made available to clinicians at the time of testing, but the quantitative result remained blinded until after delivery.RESULTS: Spontaneous preterm birth (less than 34 weeks of gestation) increased from 2.7%, 11.0%, 14.9%, 33.9%, and 47.6% with increasing concentration of fetal fibronectin (less than 10, 10-49, 50-199, 200-499, and 500 ng/mL or greater, respectively). A threshold of 200 ng/mL had a positive predictive value of 37.7 (95% confidence interval [CI] 26.9-49.4) with specificity 96% (95% CI 95.3-97.3). Women with a fetal fibronectin concentration of less than 10 ng/mL had a very low risk of spontaneous preterm birth at less than 34 weeks of gestation (2.7%), no higher than the background spontaneous preterm birth rate of the general hospital population (3.3%). The quantitative fetal fibronectin test predicted birth at less than 34 weeks of gestation with an area under the curve (AUC) of 0.78 (95% CI 0.73-0.84) compared with the qualitative test AUC 0.68 (95% CI 0.63-0.73). Quantitative fetal fibronectin discriminated risk of spontaneous preterm birth at less than 34 weeks of gestation among women with a short cervix (less than 25 mm); 9.5% delivered prematurely less than 10 ng/mL compared with 55.1% greater than 200 ng/mL (P<.001).DISCUSSION: Alternative risk thresholds (less than 10 ng/mL and greater than 200 ng/mL) improve accuracy when using quantitative fetal fibronectin measurements to define risk of spontaneous preterm birth. This is particularly relevant for asymptomatic women with a short cervix.LEVEL OF EVIDENCE: II.

AB - OBJECTIVE: To evaluate the diagnostic accuracy of cervicovaginal fluid quantitative fetal fibronectin, measured by a bedside analyzer, to predict spontaneous preterm birth before 34 weeks of gestation.METHODS: We conducted a prospective masked observational cohort study of cervicovaginal fluid quantitative fetal fibronectin concentration in asymptomatic women at high risk of spontaneous preterm birth (n=1,448; 22-27 6/7 weeks of gestation) measured using a rapid bedside analyzer. The routine qualitative result (positive-negative) was made available to clinicians at the time of testing, but the quantitative result remained blinded until after delivery.RESULTS: Spontaneous preterm birth (less than 34 weeks of gestation) increased from 2.7%, 11.0%, 14.9%, 33.9%, and 47.6% with increasing concentration of fetal fibronectin (less than 10, 10-49, 50-199, 200-499, and 500 ng/mL or greater, respectively). A threshold of 200 ng/mL had a positive predictive value of 37.7 (95% confidence interval [CI] 26.9-49.4) with specificity 96% (95% CI 95.3-97.3). Women with a fetal fibronectin concentration of less than 10 ng/mL had a very low risk of spontaneous preterm birth at less than 34 weeks of gestation (2.7%), no higher than the background spontaneous preterm birth rate of the general hospital population (3.3%). The quantitative fetal fibronectin test predicted birth at less than 34 weeks of gestation with an area under the curve (AUC) of 0.78 (95% CI 0.73-0.84) compared with the qualitative test AUC 0.68 (95% CI 0.63-0.73). Quantitative fetal fibronectin discriminated risk of spontaneous preterm birth at less than 34 weeks of gestation among women with a short cervix (less than 25 mm); 9.5% delivered prematurely less than 10 ng/mL compared with 55.1% greater than 200 ng/mL (P<.001).DISCUSSION: Alternative risk thresholds (less than 10 ng/mL and greater than 200 ng/mL) improve accuracy when using quantitative fetal fibronectin measurements to define risk of spontaneous preterm birth. This is particularly relevant for asymptomatic women with a short cervix.LEVEL OF EVIDENCE: II.

KW - Adult

KW - Area Under Curve

KW - Asymptomatic Diseases

KW - Cervix Uteri/diagnostic imaging

KW - Female

KW - Fetus/metabolism

KW - Fibronectins/metabolism

KW - Humans

KW - Predictive Value of Tests

KW - Premature Birth/diagnosis

KW - Prospective Studies

KW - Ultrasonography

U2 - 10.1097/AOG.0000000000000754

DO - 10.1097/AOG.0000000000000754

M3 - Article (Academic Journal)

C2 - 25932845

SN - 0029-7844

VL - 125

SP - 1168

EP - 1176

JO - Obstetrics and Gynecology

JF - Obstetrics and Gynecology

IS - 5

ER -

Quantitative fetal fibronectin to predict preterm birth in asymptomatic women at high risk

Abstract

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