Predictive accuracy of serial transvaginal cervical lengths and quantitative vaginal fetal fibronectin levels for spontaneous preterm birth among nulliparous women

M. Sean Esplin*, Michal A. Elovitz, Jay D. Iams, Corette B. Parker, Ronald J. Wapner, William A Grobman, Hyagriv N. Simhan, Deborah A. Wing, David M. Haas, Robert M. Silver, Matthew K. Hoffman, Alan M Peaceman, Steve N. Caritis, Samuel Parry, Pathik Wadhwa, Tatiana Foroud, Brian M. Mercer, Shannon M. Hunter, George R. Saade, Uma M. Reddy

*Corresponding author for this work

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

IMPORTANCE Spontaneous preterm birth is a leading cause of infant mortality. Prediction, largely based on prior pregnancy outcomes, is not possible in women pregnant for the first time. OBJECTIVE To assess the accuracy of universal screening to predict spontaneous preterm birth in nulliparous women using serial measurements of vaginal fetal fibronectin levels and cervical length. DESIGN, SETTINGS, AND PARTICIPANTS A prospective observational cohort study of nulliparous women with singleton pregnancies, from 8 clinical sites across the United States between October 2010 and May 2014.Women and clinicians were blinded to results unless cervical shortening less than 15mmwas identified. EXPOSURES Transvaginal cervical length and quantitative vaginal fetal fibronectin levels were reviewed at 2 study visits 4 or more weeks apart. MAIN OUTCOMES AND MEASURES Spontaneous preterm birth at less than 37weekswas the primary outcome. Cervical length and quantitative fetal fibronectin were considered independently and together at each visit. Measurement distributions were compared for spontaneous preterm birth vs all other births. Spontaneous preterm birth before 32 weeks was a secondary outcome. RESULTS The study included 9410 women (median age, 27.0 [interquartile range, 9.0] years; 60.7%non-Hispanic white, 13.8% non-Hispanic black, 16.5%Hispanic, 4.0%Asian, and 5.1% other), of whom 474 (5.0%) had spontaneous preterm births, 335 (3.6%) had medically indicated preterm births, and 8601 (91.4%) had term births. Among women with spontaneous preterm birth, cervical length of 25mmor less occurred in 35 of 439 (8.0%) at 16 to 22 weeks' gestation and in 94 of 403 (23.3%) at 22 to 30 weeks' gestation. Fetal fibronectin levels of 50 ng/mL or greater at 16 to 22 weeks identified 30 of 410 women (7.3%) with spontaneous preterm birth and 31 of 384 (8.1%) at 22 to 30 weeks. The area under the receiver operating characteristic curve for screening between 22 and 30 weeks for fetal fibronectin level alone was 0.59 (95%CI, 0.56-0.62), for transvaginal cervical length alone was 0.67 (95%CI, 0.64-0.70), and for the combination as continuous variables was 0.67 (95%CI, 0.64-0.70). CONCLUSIONS AND RELEVANCE Among nulliparouswomen with singleton pregnancies, quantitative vaginal fetal fibronectin and serial transvaginal ultrasound cervical length had low predictive accuracy for spontaneous preterm birth. These findings do not support routine use of these tests in such women.

Original languageEnglish (US)
Pages (from-to)1047-1056
Number of pages10
JournalJAMA - Journal of the American Medical Association
Volume317
Issue number10
DOIs
StatePublished - Mar 14 2017

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Premature Birth
Fibronectins
Pregnancy
Term Birth
Infant Mortality
Pregnancy Outcome
Hispanic Americans
ROC Curve
Observational Studies
Pregnant Women
Cohort Studies
Parturition

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Esplin, M. Sean ; Elovitz, Michal A. ; Iams, Jay D. ; Parker, Corette B. ; Wapner, Ronald J. ; Grobman, William A ; Simhan, Hyagriv N. ; Wing, Deborah A. ; Haas, David M. ; Silver, Robert M. ; Hoffman, Matthew K. ; Peaceman, Alan M ; Caritis, Steve N. ; Parry, Samuel ; Wadhwa, Pathik ; Foroud, Tatiana ; Mercer, Brian M. ; Hunter, Shannon M. ; Saade, George R. ; Reddy, Uma M. / Predictive accuracy of serial transvaginal cervical lengths and quantitative vaginal fetal fibronectin levels for spontaneous preterm birth among nulliparous women. In: JAMA - Journal of the American Medical Association. 2017 ; Vol. 317, No. 10. pp. 1047-1056.
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title = "Predictive accuracy of serial transvaginal cervical lengths and quantitative vaginal fetal fibronectin levels for spontaneous preterm birth among nulliparous women",
abstract = "IMPORTANCE Spontaneous preterm birth is a leading cause of infant mortality. Prediction, largely based on prior pregnancy outcomes, is not possible in women pregnant for the first time. OBJECTIVE To assess the accuracy of universal screening to predict spontaneous preterm birth in nulliparous women using serial measurements of vaginal fetal fibronectin levels and cervical length. DESIGN, SETTINGS, AND PARTICIPANTS A prospective observational cohort study of nulliparous women with singleton pregnancies, from 8 clinical sites across the United States between October 2010 and May 2014.Women and clinicians were blinded to results unless cervical shortening less than 15mmwas identified. EXPOSURES Transvaginal cervical length and quantitative vaginal fetal fibronectin levels were reviewed at 2 study visits 4 or more weeks apart. MAIN OUTCOMES AND MEASURES Spontaneous preterm birth at less than 37weekswas the primary outcome. Cervical length and quantitative fetal fibronectin were considered independently and together at each visit. Measurement distributions were compared for spontaneous preterm birth vs all other births. Spontaneous preterm birth before 32 weeks was a secondary outcome. RESULTS The study included 9410 women (median age, 27.0 [interquartile range, 9.0] years; 60.7{\%}non-Hispanic white, 13.8{\%} non-Hispanic black, 16.5{\%}Hispanic, 4.0{\%}Asian, and 5.1{\%} other), of whom 474 (5.0{\%}) had spontaneous preterm births, 335 (3.6{\%}) had medically indicated preterm births, and 8601 (91.4{\%}) had term births. Among women with spontaneous preterm birth, cervical length of 25mmor less occurred in 35 of 439 (8.0{\%}) at 16 to 22 weeks' gestation and in 94 of 403 (23.3{\%}) at 22 to 30 weeks' gestation. Fetal fibronectin levels of 50 ng/mL or greater at 16 to 22 weeks identified 30 of 410 women (7.3{\%}) with spontaneous preterm birth and 31 of 384 (8.1{\%}) at 22 to 30 weeks. The area under the receiver operating characteristic curve for screening between 22 and 30 weeks for fetal fibronectin level alone was 0.59 (95{\%}CI, 0.56-0.62), for transvaginal cervical length alone was 0.67 (95{\%}CI, 0.64-0.70), and for the combination as continuous variables was 0.67 (95{\%}CI, 0.64-0.70). CONCLUSIONS AND RELEVANCE Among nulliparouswomen with singleton pregnancies, quantitative vaginal fetal fibronectin and serial transvaginal ultrasound cervical length had low predictive accuracy for spontaneous preterm birth. These findings do not support routine use of these tests in such women.",
author = "Esplin, {M. Sean} and Elovitz, {Michal A.} and Iams, {Jay D.} and Parker, {Corette B.} and Wapner, {Ronald J.} and Grobman, {William A} and Simhan, {Hyagriv N.} and Wing, {Deborah A.} and Haas, {David M.} and Silver, {Robert M.} and Hoffman, {Matthew K.} and Peaceman, {Alan M} and Caritis, {Steve N.} and Samuel Parry and Pathik Wadhwa and Tatiana Foroud and Mercer, {Brian M.} and Hunter, {Shannon M.} and Saade, {George R.} and Reddy, {Uma M.}",
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Esplin, MS, Elovitz, MA, Iams, JD, Parker, CB, Wapner, RJ, Grobman, WA, Simhan, HN, Wing, DA, Haas, DM, Silver, RM, Hoffman, MK, Peaceman, AM, Caritis, SN, Parry, S, Wadhwa, P, Foroud, T, Mercer, BM, Hunter, SM, Saade, GR & Reddy, UM 2017, 'Predictive accuracy of serial transvaginal cervical lengths and quantitative vaginal fetal fibronectin levels for spontaneous preterm birth among nulliparous women', JAMA - Journal of the American Medical Association, vol. 317, no. 10, pp. 1047-1056. https://doi.org/10.1001/jama.2017.1373

Predictive accuracy of serial transvaginal cervical lengths and quantitative vaginal fetal fibronectin levels for spontaneous preterm birth among nulliparous women. / Esplin, M. Sean; Elovitz, Michal A.; Iams, Jay D.; Parker, Corette B.; Wapner, Ronald J.; Grobman, William A; Simhan, Hyagriv N.; Wing, Deborah A.; Haas, David M.; Silver, Robert M.; Hoffman, Matthew K.; Peaceman, Alan M; Caritis, Steve N.; Parry, Samuel; Wadhwa, Pathik; Foroud, Tatiana; Mercer, Brian M.; Hunter, Shannon M.; Saade, George R.; Reddy, Uma M.

In: JAMA - Journal of the American Medical Association, Vol. 317, No. 10, 14.03.2017, p. 1047-1056.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Predictive accuracy of serial transvaginal cervical lengths and quantitative vaginal fetal fibronectin levels for spontaneous preterm birth among nulliparous women

AU - Esplin, M. Sean

AU - Elovitz, Michal A.

AU - Iams, Jay D.

AU - Parker, Corette B.

AU - Wapner, Ronald J.

AU - Grobman, William A

AU - Simhan, Hyagriv N.

AU - Wing, Deborah A.

AU - Haas, David M.

AU - Silver, Robert M.

AU - Hoffman, Matthew K.

AU - Peaceman, Alan M

AU - Caritis, Steve N.

AU - Parry, Samuel

AU - Wadhwa, Pathik

AU - Foroud, Tatiana

AU - Mercer, Brian M.

AU - Hunter, Shannon M.

AU - Saade, George R.

AU - Reddy, Uma M.

PY - 2017/3/14

Y1 - 2017/3/14

N2 - IMPORTANCE Spontaneous preterm birth is a leading cause of infant mortality. Prediction, largely based on prior pregnancy outcomes, is not possible in women pregnant for the first time. OBJECTIVE To assess the accuracy of universal screening to predict spontaneous preterm birth in nulliparous women using serial measurements of vaginal fetal fibronectin levels and cervical length. DESIGN, SETTINGS, AND PARTICIPANTS A prospective observational cohort study of nulliparous women with singleton pregnancies, from 8 clinical sites across the United States between October 2010 and May 2014.Women and clinicians were blinded to results unless cervical shortening less than 15mmwas identified. EXPOSURES Transvaginal cervical length and quantitative vaginal fetal fibronectin levels were reviewed at 2 study visits 4 or more weeks apart. MAIN OUTCOMES AND MEASURES Spontaneous preterm birth at less than 37weekswas the primary outcome. Cervical length and quantitative fetal fibronectin were considered independently and together at each visit. Measurement distributions were compared for spontaneous preterm birth vs all other births. Spontaneous preterm birth before 32 weeks was a secondary outcome. RESULTS The study included 9410 women (median age, 27.0 [interquartile range, 9.0] years; 60.7%non-Hispanic white, 13.8% non-Hispanic black, 16.5%Hispanic, 4.0%Asian, and 5.1% other), of whom 474 (5.0%) had spontaneous preterm births, 335 (3.6%) had medically indicated preterm births, and 8601 (91.4%) had term births. Among women with spontaneous preterm birth, cervical length of 25mmor less occurred in 35 of 439 (8.0%) at 16 to 22 weeks' gestation and in 94 of 403 (23.3%) at 22 to 30 weeks' gestation. Fetal fibronectin levels of 50 ng/mL or greater at 16 to 22 weeks identified 30 of 410 women (7.3%) with spontaneous preterm birth and 31 of 384 (8.1%) at 22 to 30 weeks. The area under the receiver operating characteristic curve for screening between 22 and 30 weeks for fetal fibronectin level alone was 0.59 (95%CI, 0.56-0.62), for transvaginal cervical length alone was 0.67 (95%CI, 0.64-0.70), and for the combination as continuous variables was 0.67 (95%CI, 0.64-0.70). CONCLUSIONS AND RELEVANCE Among nulliparouswomen with singleton pregnancies, quantitative vaginal fetal fibronectin and serial transvaginal ultrasound cervical length had low predictive accuracy for spontaneous preterm birth. These findings do not support routine use of these tests in such women.

AB - IMPORTANCE Spontaneous preterm birth is a leading cause of infant mortality. Prediction, largely based on prior pregnancy outcomes, is not possible in women pregnant for the first time. OBJECTIVE To assess the accuracy of universal screening to predict spontaneous preterm birth in nulliparous women using serial measurements of vaginal fetal fibronectin levels and cervical length. DESIGN, SETTINGS, AND PARTICIPANTS A prospective observational cohort study of nulliparous women with singleton pregnancies, from 8 clinical sites across the United States between October 2010 and May 2014.Women and clinicians were blinded to results unless cervical shortening less than 15mmwas identified. EXPOSURES Transvaginal cervical length and quantitative vaginal fetal fibronectin levels were reviewed at 2 study visits 4 or more weeks apart. MAIN OUTCOMES AND MEASURES Spontaneous preterm birth at less than 37weekswas the primary outcome. Cervical length and quantitative fetal fibronectin were considered independently and together at each visit. Measurement distributions were compared for spontaneous preterm birth vs all other births. Spontaneous preterm birth before 32 weeks was a secondary outcome. RESULTS The study included 9410 women (median age, 27.0 [interquartile range, 9.0] years; 60.7%non-Hispanic white, 13.8% non-Hispanic black, 16.5%Hispanic, 4.0%Asian, and 5.1% other), of whom 474 (5.0%) had spontaneous preterm births, 335 (3.6%) had medically indicated preterm births, and 8601 (91.4%) had term births. Among women with spontaneous preterm birth, cervical length of 25mmor less occurred in 35 of 439 (8.0%) at 16 to 22 weeks' gestation and in 94 of 403 (23.3%) at 22 to 30 weeks' gestation. Fetal fibronectin levels of 50 ng/mL or greater at 16 to 22 weeks identified 30 of 410 women (7.3%) with spontaneous preterm birth and 31 of 384 (8.1%) at 22 to 30 weeks. The area under the receiver operating characteristic curve for screening between 22 and 30 weeks for fetal fibronectin level alone was 0.59 (95%CI, 0.56-0.62), for transvaginal cervical length alone was 0.67 (95%CI, 0.64-0.70), and for the combination as continuous variables was 0.67 (95%CI, 0.64-0.70). CONCLUSIONS AND RELEVANCE Among nulliparouswomen with singleton pregnancies, quantitative vaginal fetal fibronectin and serial transvaginal ultrasound cervical length had low predictive accuracy for spontaneous preterm birth. These findings do not support routine use of these tests in such women.

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