Fetal fibronectin as a predictor of preterm birth in patients with symptoms

A multicenter trial

Alan M Peaceman*, W. W. Andrews, J. M. Thorp, S. P. Cliver, A. Lukes, J. D. Iams, L. Coultrip, N. Eriksen, R. H. Holbrook, J. Elliott, C. Ingardia, M. Pietrantoni

*Corresponding author for this work

Research output: Contribution to journalArticle

252 Citations (Scopus)

Abstract

OBJECTIVE: Our aim was to determine whether the presence of fetal fibronectin in vaginal secretions of patients with symptoms suggestive of preterm labor predicts preterm delivery. STUDY DESIGN: Patients who were examined at the hospital between 24 weeks' and 84 weeks 6 days' gestation with intact membranes, no prior tocolysis, symptoms suggestive of preterm labor, and cervical dilation <3 cm were recruited at 10 sites. Swabs of the posterior fornix were assayed for the presence of fetal fibronectin by monoclonal antibody assay, with a positive result defined as ≤50 ng/ml. Results were not available to the managing physicians. Tocolysis was used when clinically indicated after specimen collection. RESULTS: A total of 763 patients had fetal fibronectin results and pregnancy outcome data available for analysis. Fetal fibronectin was detected in specimens from 150 (20%) patients. Compared with patients who had negative results, patients who had positive results for fetal fibronectin were more likely to be delivered within 7 days (relative risk 25.9 [95% confidence interval 7.8 to 86]), within 14 days (relative risk 20.4 [95% confidence interval 8.0 to 53]), and before 37 completed weeks (relative risk 2.9 [95% confidence interval 2.2 to 3.7]). The negative predictive values for delivery within 7 days, within 14 days, and at <37 weeks were 99.5%, 99.2%, and 84.5%, respectively. When we used multiple logistic regression analysis to control for potential confounding variables among singleton pregnancies, only the presence of fetal fibronectin (odds ratio 48.8, 95% confidence interval 7.4 to 320), prior preterm birth (odds ratio 8.3, 95% confidence interval 1.5 to 46.6), and tocolysis (odds ratio 4.1, 95% confidence interval 1.0 to 16.0) were associated with birth within 7 days; fetal fibronectin (odds ratio 3.6, 95% confidence interval 2.2 to 5.9), prior preterm birth (odds ratio 2.5, 95% confidence interval 1.4 to 4.4), cervical dilatation >1 cm (odds ratio 2.9, 95% confidence interval 1.6 to 5.2), and tocolysis (odds ratio 4.5, 95% confidence interval 2.8 to 7.2) were all independently associated with delivery before 37 weeks. CONCLUSION: In a population of patients with symptoms, the presence of fetal fibronectin in vaginal secretions best defines a subgroup at increased risk for delivery within 7 days; the high negative predictive value of fetal fibronectin sampling supports less intervention for patients with this result.

Original languageEnglish (US)
Pages (from-to)13-18
Number of pages6
JournalAmerican Journal of Obstetrics and Gynecology
Volume177
Issue number1
DOIs
StatePublished - Jan 1 1997

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Premature Birth
Fibronectins
Multicenter Studies
Tocolysis
Premature Obstetric Labor
Odds Ratio
Confidence Intervals
Dilatation
Pregnancy
Membranes
Population

Keywords

  • Fetal fibronectin
  • Prematurity
  • Preterm birth

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Peaceman, Alan M ; Andrews, W. W. ; Thorp, J. M. ; Cliver, S. P. ; Lukes, A. ; Iams, J. D. ; Coultrip, L. ; Eriksen, N. ; Holbrook, R. H. ; Elliott, J. ; Ingardia, C. ; Pietrantoni, M. / Fetal fibronectin as a predictor of preterm birth in patients with symptoms : A multicenter trial. In: American Journal of Obstetrics and Gynecology. 1997 ; Vol. 177, No. 1. pp. 13-18.
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abstract = "OBJECTIVE: Our aim was to determine whether the presence of fetal fibronectin in vaginal secretions of patients with symptoms suggestive of preterm labor predicts preterm delivery. STUDY DESIGN: Patients who were examined at the hospital between 24 weeks' and 84 weeks 6 days' gestation with intact membranes, no prior tocolysis, symptoms suggestive of preterm labor, and cervical dilation <3 cm were recruited at 10 sites. Swabs of the posterior fornix were assayed for the presence of fetal fibronectin by monoclonal antibody assay, with a positive result defined as ≤50 ng/ml. Results were not available to the managing physicians. Tocolysis was used when clinically indicated after specimen collection. RESULTS: A total of 763 patients had fetal fibronectin results and pregnancy outcome data available for analysis. Fetal fibronectin was detected in specimens from 150 (20{\%}) patients. Compared with patients who had negative results, patients who had positive results for fetal fibronectin were more likely to be delivered within 7 days (relative risk 25.9 [95{\%} confidence interval 7.8 to 86]), within 14 days (relative risk 20.4 [95{\%} confidence interval 8.0 to 53]), and before 37 completed weeks (relative risk 2.9 [95{\%} confidence interval 2.2 to 3.7]). The negative predictive values for delivery within 7 days, within 14 days, and at <37 weeks were 99.5{\%}, 99.2{\%}, and 84.5{\%}, respectively. When we used multiple logistic regression analysis to control for potential confounding variables among singleton pregnancies, only the presence of fetal fibronectin (odds ratio 48.8, 95{\%} confidence interval 7.4 to 320), prior preterm birth (odds ratio 8.3, 95{\%} confidence interval 1.5 to 46.6), and tocolysis (odds ratio 4.1, 95{\%} confidence interval 1.0 to 16.0) were associated with birth within 7 days; fetal fibronectin (odds ratio 3.6, 95{\%} confidence interval 2.2 to 5.9), prior preterm birth (odds ratio 2.5, 95{\%} confidence interval 1.4 to 4.4), cervical dilatation >1 cm (odds ratio 2.9, 95{\%} confidence interval 1.6 to 5.2), and tocolysis (odds ratio 4.5, 95{\%} confidence interval 2.8 to 7.2) were all independently associated with delivery before 37 weeks. CONCLUSION: In a population of patients with symptoms, the presence of fetal fibronectin in vaginal secretions best defines a subgroup at increased risk for delivery within 7 days; the high negative predictive value of fetal fibronectin sampling supports less intervention for patients with this result.",
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Peaceman, AM, Andrews, WW, Thorp, JM, Cliver, SP, Lukes, A, Iams, JD, Coultrip, L, Eriksen, N, Holbrook, RH, Elliott, J, Ingardia, C & Pietrantoni, M 1997, 'Fetal fibronectin as a predictor of preterm birth in patients with symptoms: A multicenter trial', American Journal of Obstetrics and Gynecology, vol. 177, no. 1, pp. 13-18. https://doi.org/10.1016/S0002-9378(97)70431-9

Fetal fibronectin as a predictor of preterm birth in patients with symptoms : A multicenter trial. / Peaceman, Alan M; Andrews, W. W.; Thorp, J. M.; Cliver, S. P.; Lukes, A.; Iams, J. D.; Coultrip, L.; Eriksen, N.; Holbrook, R. H.; Elliott, J.; Ingardia, C.; Pietrantoni, M.

In: American Journal of Obstetrics and Gynecology, Vol. 177, No. 1, 01.01.1997, p. 13-18.

Research output: Contribution to journalArticle

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T1 - Fetal fibronectin as a predictor of preterm birth in patients with symptoms

T2 - A multicenter trial

AU - Peaceman, Alan M

AU - Andrews, W. W.

AU - Thorp, J. M.

AU - Cliver, S. P.

AU - Lukes, A.

AU - Iams, J. D.

AU - Coultrip, L.

AU - Eriksen, N.

AU - Holbrook, R. H.

AU - Elliott, J.

AU - Ingardia, C.

AU - Pietrantoni, M.

PY - 1997/1/1

Y1 - 1997/1/1

N2 - OBJECTIVE: Our aim was to determine whether the presence of fetal fibronectin in vaginal secretions of patients with symptoms suggestive of preterm labor predicts preterm delivery. STUDY DESIGN: Patients who were examined at the hospital between 24 weeks' and 84 weeks 6 days' gestation with intact membranes, no prior tocolysis, symptoms suggestive of preterm labor, and cervical dilation <3 cm were recruited at 10 sites. Swabs of the posterior fornix were assayed for the presence of fetal fibronectin by monoclonal antibody assay, with a positive result defined as ≤50 ng/ml. Results were not available to the managing physicians. Tocolysis was used when clinically indicated after specimen collection. RESULTS: A total of 763 patients had fetal fibronectin results and pregnancy outcome data available for analysis. Fetal fibronectin was detected in specimens from 150 (20%) patients. Compared with patients who had negative results, patients who had positive results for fetal fibronectin were more likely to be delivered within 7 days (relative risk 25.9 [95% confidence interval 7.8 to 86]), within 14 days (relative risk 20.4 [95% confidence interval 8.0 to 53]), and before 37 completed weeks (relative risk 2.9 [95% confidence interval 2.2 to 3.7]). The negative predictive values for delivery within 7 days, within 14 days, and at <37 weeks were 99.5%, 99.2%, and 84.5%, respectively. When we used multiple logistic regression analysis to control for potential confounding variables among singleton pregnancies, only the presence of fetal fibronectin (odds ratio 48.8, 95% confidence interval 7.4 to 320), prior preterm birth (odds ratio 8.3, 95% confidence interval 1.5 to 46.6), and tocolysis (odds ratio 4.1, 95% confidence interval 1.0 to 16.0) were associated with birth within 7 days; fetal fibronectin (odds ratio 3.6, 95% confidence interval 2.2 to 5.9), prior preterm birth (odds ratio 2.5, 95% confidence interval 1.4 to 4.4), cervical dilatation >1 cm (odds ratio 2.9, 95% confidence interval 1.6 to 5.2), and tocolysis (odds ratio 4.5, 95% confidence interval 2.8 to 7.2) were all independently associated with delivery before 37 weeks. CONCLUSION: In a population of patients with symptoms, the presence of fetal fibronectin in vaginal secretions best defines a subgroup at increased risk for delivery within 7 days; the high negative predictive value of fetal fibronectin sampling supports less intervention for patients with this result.

AB - OBJECTIVE: Our aim was to determine whether the presence of fetal fibronectin in vaginal secretions of patients with symptoms suggestive of preterm labor predicts preterm delivery. STUDY DESIGN: Patients who were examined at the hospital between 24 weeks' and 84 weeks 6 days' gestation with intact membranes, no prior tocolysis, symptoms suggestive of preterm labor, and cervical dilation <3 cm were recruited at 10 sites. Swabs of the posterior fornix were assayed for the presence of fetal fibronectin by monoclonal antibody assay, with a positive result defined as ≤50 ng/ml. Results were not available to the managing physicians. Tocolysis was used when clinically indicated after specimen collection. RESULTS: A total of 763 patients had fetal fibronectin results and pregnancy outcome data available for analysis. Fetal fibronectin was detected in specimens from 150 (20%) patients. Compared with patients who had negative results, patients who had positive results for fetal fibronectin were more likely to be delivered within 7 days (relative risk 25.9 [95% confidence interval 7.8 to 86]), within 14 days (relative risk 20.4 [95% confidence interval 8.0 to 53]), and before 37 completed weeks (relative risk 2.9 [95% confidence interval 2.2 to 3.7]). The negative predictive values for delivery within 7 days, within 14 days, and at <37 weeks were 99.5%, 99.2%, and 84.5%, respectively. When we used multiple logistic regression analysis to control for potential confounding variables among singleton pregnancies, only the presence of fetal fibronectin (odds ratio 48.8, 95% confidence interval 7.4 to 320), prior preterm birth (odds ratio 8.3, 95% confidence interval 1.5 to 46.6), and tocolysis (odds ratio 4.1, 95% confidence interval 1.0 to 16.0) were associated with birth within 7 days; fetal fibronectin (odds ratio 3.6, 95% confidence interval 2.2 to 5.9), prior preterm birth (odds ratio 2.5, 95% confidence interval 1.4 to 4.4), cervical dilatation >1 cm (odds ratio 2.9, 95% confidence interval 1.6 to 5.2), and tocolysis (odds ratio 4.5, 95% confidence interval 2.8 to 7.2) were all independently associated with delivery before 37 weeks. CONCLUSION: In a population of patients with symptoms, the presence of fetal fibronectin in vaginal secretions best defines a subgroup at increased risk for delivery within 7 days; the high negative predictive value of fetal fibronectin sampling supports less intervention for patients with this result.

KW - Fetal fibronectin

KW - Prematurity

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