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Does hospitalization prevent preterm delivery in the patient with a short cervix?
S52 SMFM Abstracts 143 DOES HOSPITALIZATION PREVENT PRETERM DELIVERY IN THE PATIENT WITH A SHORT CERVIX? NATHAN S. FOX (F)1, CLAUDEL JEAN-PIERRE1, MLADEN PREDANIC1, STEPHEN T. CHASEN1, 1Weill Medical College of Cornell University, Obstetrics and Gynecology, New York, New York OBJECTIVE: Cervical length measurements are often obtained in the second and early third trimester. Many patients found to have a short cervix are placed on bedrest and some are hospitalized. Our objective was to review data from our institution to see if admission to the hospital delayed delivery, prevented preterm delivery, and/or decreased the rate of change in the cervical length on follow up measurements. STUDY DESIGN: We searched our OB ultrasound database for all cervical lengths !26 mm at gestational ages 16 to 28 weeks from July 2002 through July 2005. All patients managed expectantly (no cerclage placement or elective termination of pregnancy) who had a follow-up measurement within 3 weeks were included. Hospitalization and delivery data were obtained from the patients’ computerized medical record. RESULTS: 109 patients met criteria for inclusion, 61 of whom (56%) were admitted. As of July 2005, delivery data was available for 88 patients. On univariate analysis, admission to the hospital correlated with delivery !34 weeks (p=.007), delivery !37 weeks (p=.005), and an earlier gestational age at delivery (p=.002). The other factors associated with preterm delivery were twin gestation, older maternal age and shorter initial cervical length. None of these parameters correlated with a shorter cervical length on follow-up ultrasound, other than a trend towards becoming shorter in the hospitalized group (p=.06). Multivariate regression analysis looking at the significant factors (age, initial cervical length, twin pregnancy, and hospitalization) showed a correlation between older age and twin gestation with preterm delivery and a trend towards preterm delivery for hospitalized patients. Initial cervical length was not found to be predictive of preterm delivery on multivariate analysis. CONCLUSION: Admission to the hospital did not slow the progression of cervical shortening, with a trend towards an increased rate of preterm delivery and earlier gestational age at delivery. Older maternal age and twin gestation were both independent risk factors for preterm delivery.
145 IMPLEMENTATION OF FETAL FIBRONECTIN (FFN) TESTING IN A LARGE PRIVATE PRACTICE HOSPITAL IS SAFE AND EFFECTIVE FOR THE DIAGNOSIS AND MANAGEMENT OF PRETERM LABOR (PTL) HERMAN L. HEDRIANA1, MARY CAMPBELL BLISS1, WILLIAM M. GILBERT1, 1Sutter Medical Center, Sacramento, OB/GYN Department, Sacramento, California OBJECTIVE: To test the safety and effectiveness of the implementation of rapid fFN (R-fFN) testing for diagnosis of PTL in a large private hospital setting. STUDY DESIGN: Because of practice variations, a uniform protocol for the use of R-fFN test was started at Sutter Memorial Hospital on 4/1/2000 to determine its effectiveness in PTL cases. Symptomatic women (contractions with intact membranes, !37 weeks’ gestation) had a sterile speculum exam during which a R-fFN sample was obtained before further evaluation. Results were available in !1 hr. Management was based upon the R-fFN test result and presenting clinical factors. RESULTS: From 4/1/2000 to 3/31/2002, 502 women had the R-fFN with 422 (84%) negative and 80 (16%) positive results. Of the negative R-fFN tests, 5 (1.2%) delivered at !14 days, with 3 of these cases being delivered for reasons other than PTL (Preeclampsia, HELLP, Fetal distress). Of the 80 positive R-fFN tests, 14 (17.5%) delivered ! 7 days and 8 (10%) delivered between 7-14 days. Average length of stay (LOS) for patients with the primary diagnosis of PTL discharged undelivered (ICD9-CM 644.03) in the 6 months before 4/1/2000 was 3.4 days G 0.21 days compared to 1.34 G 0.07 days, 6 months into the study (P ! 0.001). Average evaluation time of presenting symptomatic PTL patients 6 months before 4/1/2000 was 6.0 G 0.7 hrs compared to 1.6 G 0.24 hrs, 6 months into the study (P ! 0.001). CONCLUSION: The institution of a uniform R-fFN testing program in a large private practice hospital demonstrated the safety and reliability of a negative R-fFN test with a false negative rate of delivery within 14 days of 1.2%, and probably less for isolated PTL (0.5%). A positive R-fFN test demonstrated rates of preterm delivery similar to earlier published studies from research institutions. Decreased LOS, time of evaluation, improved resource utilization and standardization of practice amongst independent practitioners, further support the use of R-fFN testing for symptomatic PTL.
144 A COMPARISON OF SPECULUM AND NON-SPECULUM COLLECTION OF CERVICOVAGINAL SWAB SPECIMENS FOR FETAL FIBRONECTIN TESTING THOMAS GARITE1, ALFREDO COLON LUCAH2, CATHERINE WILLIAMS3, BECKY BOBRITCHI3, JEROME LAPOINTE3, 1University of California, Irvine, Obstetrics & Gynecology, Orange, California, 2Instituto Mexicano del Seguro Social, Hospital General Regional No. 1, Tijuana, BCN, Mexico, 3Adeza Biomedical, Sunnyvale, California OBJECTIVE: Cervicovaginal specimen collection(CVfFN) for fetal fibronectin (fFN) testing is often done in a hospital setting and the requirement for speculum directed collection often deters the nurse from collecting a sample. This study evaluates the equivalency of a non-speculum method for collecting CVfFN. STUDY DESIGN: The alternative method of collection used in this study is performed by inserting a finger into the vagina, depressing downward and inserting a polyester swab along the finger to allow collection in the posterior fornix. A prospective study of consenting patients from 22 to 43 weeks gestation was performed. Two sequential specimens were collected on each patient: one with speculum and one with the non-speculum method. The order of collection was reversed in ½ of the subjects to assess whether order of collection (non-speculum first or second, speculum first or second) influenced test results. RESULTS: Eighteen different clinicians collected paired specimens from each of 169 women. Comparison of the fFN test results between the speculum and non-speculum methods demonstrated 95.3% agreement with an intraclass kappa coefficient of 0.90 (95%CI: 0.82,0.97). Moreover, the correlation of the fFN values in each specimen pair was 0.93 (p!0.0001, Pearson) and there was no difference in the fFN values among the two collection methods (p=0.43). Additionally, the order of collection did not result in different fFN averages (pO0.57 in all 4 comparisons). When the fFN test results of the pairs were discordant (N=8), there was no trend in the direction of the results for one method over the other (5 C speculum/- with non-speculum and 3 C nonspeculum/- with speculum). CONCLUSION: This study demonstrates that specimens collected from the vaginal posterior fornix with either a speculum or non-speculum method yield fFN results which are in excellent agreement and suggests this alternative method may be useful in clinical practice.
146 HIVNET 024: FETAL FIBRONECTIN (FFN), PRETERM BIRTH (PTB) AND MOTHER TO CHILD TRANSMISSION OF HIV (MTCT) IN AFRICAN WOMEN WITH HIV ROBERT GOLDENBERG1, WILLIAM ANDREWS1, TAHA TAHA2, WAFAIE FAWZI3, ELIZABETH BROWN4, 1University of Alabama at Birmingham, Obstetrics/ Gynecology, Birmingham, Alabama, 2Johns Hopkins University, Baltimore, Maryland, 3Harvard University, Boston, Massachusetts, 4Fred Hutchinson Cancer Research Center, Seattle, Washington OBJECTIVE: Cervical or vaginal FFN levels have been studied extensively in developed countries as a predictor of PTB. Our goal was to evaluate the relationship between FFN levels and gestational age (GA), birthweight (BWT) and MTCT of HIV in a large African population of predominately HIVinfected women. STUDY DESIGN: 2098 HIV-infected and 335 HIV-uninfected women participated in a randomized trial of antibiotics, (Metronidazole 250 mg and Erythromycin 250 mg tid ! 7 days at 20-24 wks and Metronidazole 250 mg and Ampicillin 500 mg q 4 hrs with onset of PROM or labor or identically appearing placebos) to reduce MTCT of HIV and PTB. (Antibiotics had no impact on either outcome.) Vaginal FFN samples were collected prior to antibiotic treatment and at approximately 28 wks, and quantitatively assayed. RESULTS: At 20-24 wks, 4.0% and at 26-30 wks, 4.9% of samples had R50 ng/ml FFN. FFN levels R50 ng/ml at 26-30 wks, but not 20-24 wks, were strongly associated with a variety of PTB outcomes: a decrease in mean BWT of 199g (p!0.0001), a 2 wk decrease in mean GA (p!0.0001); a 6-fold increase in PTB !32 wks (10.8 vs 1.9% p!0.001, OR=6.29 (3.19,12.3)); a 3fold increase in PTB !35 wks (26.1 vs 9.5% p!0.0001, OR=3.37 (2.15,5.26)); a 2-fold increase in PTB !37wks (38.7 vs 22.0% p!0.0001, OR=2.25 (1.51,3.33)); and a 2 week decrease in duration from randomization to delivery (p! 0.0001). As FFN levels rose from !50 to O200ng/ml, the higher the level of FFN, the higher the risk of poor PTB outcomes (most test of trends p!0.0001). FFN levels O50 ng/ml at 20-24 wks but not at 26-30 wks were associated with an increase in HIV MTCT (26.6 vs 15.3% p=0.03). Antibiotic treatment had no impact on FFN levels. CONCLUSION: High FFN levels at 26-30 but not at 20-24 wks were strongly associated with adverse outcomes including PTB and low BWT. The associations were stronger for early PTB, and were stronger when FFN levels were higher. At 20-24 wks, high FFN levels were associated with MTCT of HIV.
145 IMPLEMENTATION OF FETAL FIBRONECTIN (FFN) TESTING IN A LARGE PRIVATE PRACTICE HOSPITAL IS SAFE AND EFFECTIVE FOR THE DIAGNOSIS AND MANAGEMENT OF PRETERM LABOR (PTL) HERMAN L. HEDRIANA1, MARY CAMPBELL BLISS1, WILLIAM M. GILBERT1, 1Sutter Medical Center, Sacramento, OB/GYN Department, Sacramento, California OBJECTIVE: To test the safety and effectiveness of the implementation of rapid fFN (R-fFN) testing for diagnosis of PTL in a large private hospital setting. STUDY DESIGN: Because of practice variations, a uniform protocol for the use of R-fFN test was started at Sutter Memorial Hospital on 4/1/2000 to determine its effectiveness in PTL cases. Symptomatic women (contractions with intact membranes, !37 weeks’ gestation) had a sterile speculum exam during which a R-fFN sample was obtained before further evaluation. Results were available in !1 hr. Management was based upon the R-fFN test result and presenting clinical factors. RESULTS: From 4/1/2000 to 3/31/2002, 502 women had the R-fFN with 422 (84%) negative and 80 (16%) positive results. Of the negative R-fFN tests, 5 (1.2%) delivered at !14 days, with 3 of these cases being delivered for reasons other than PTL (Preeclampsia, HELLP, Fetal distress). Of the 80 positive R-fFN tests, 14 (17.5%) delivered ! 7 days and 8 (10%) delivered between 7-14 days. Average length of stay (LOS) for patients with the primary diagnosis of PTL discharged undelivered (ICD9-CM 644.03) in the 6 months before 4/1/2000 was 3.4 days G 0.21 days compared to 1.34 G 0.07 days, 6 months into the study (P ! 0.001). Average evaluation time of presenting symptomatic PTL patients 6 months before 4/1/2000 was 6.0 G 0.7 hrs compared to 1.6 G 0.24 hrs, 6 months into the study (P ! 0.001). CONCLUSION: The institution of a uniform R-fFN testing program in a large private practice hospital demonstrated the safety and reliability of a negative R-fFN test with a false negative rate of delivery within 14 days of 1.2%, and probably less for isolated PTL (0.5%). A positive R-fFN test demonstrated rates of preterm delivery similar to earlier published studies from research institutions. Decreased LOS, time of evaluation, improved resource utilization and standardization of practice amongst independent practitioners, further support the use of R-fFN testing for symptomatic PTL.
144 A COMPARISON OF SPECULUM AND NON-SPECULUM COLLECTION OF CERVICOVAGINAL SWAB SPECIMENS FOR FETAL FIBRONECTIN TESTING THOMAS GARITE1, ALFREDO COLON LUCAH2, CATHERINE WILLIAMS3, BECKY BOBRITCHI3, JEROME LAPOINTE3, 1University of California, Irvine, Obstetrics & Gynecology, Orange, California, 2Instituto Mexicano del Seguro Social, Hospital General Regional No. 1, Tijuana, BCN, Mexico, 3Adeza Biomedical, Sunnyvale, California OBJECTIVE: Cervicovaginal specimen collection(CVfFN) for fetal fibronectin (fFN) testing is often done in a hospital setting and the requirement for speculum directed collection often deters the nurse from collecting a sample. This study evaluates the equivalency of a non-speculum method for collecting CVfFN. STUDY DESIGN: The alternative method of collection used in this study is performed by inserting a finger into the vagina, depressing downward and inserting a polyester swab along the finger to allow collection in the posterior fornix. A prospective study of consenting patients from 22 to 43 weeks gestation was performed. Two sequential specimens were collected on each patient: one with speculum and one with the non-speculum method. The order of collection was reversed in ½ of the subjects to assess whether order of collection (non-speculum first or second, speculum first or second) influenced test results. RESULTS: Eighteen different clinicians collected paired specimens from each of 169 women. Comparison of the fFN test results between the speculum and non-speculum methods demonstrated 95.3% agreement with an intraclass kappa coefficient of 0.90 (95%CI: 0.82,0.97). Moreover, the correlation of the fFN values in each specimen pair was 0.93 (p!0.0001, Pearson) and there was no difference in the fFN values among the two collection methods (p=0.43). Additionally, the order of collection did not result in different fFN averages (pO0.57 in all 4 comparisons). When the fFN test results of the pairs were discordant (N=8), there was no trend in the direction of the results for one method over the other (5 C speculum/- with non-speculum and 3 C nonspeculum/- with speculum). CONCLUSION: This study demonstrates that specimens collected from the vaginal posterior fornix with either a speculum or non-speculum method yield fFN results which are in excellent agreement and suggests this alternative method may be useful in clinical practice.
146 HIVNET 024: FETAL FIBRONECTIN (FFN), PRETERM BIRTH (PTB) AND MOTHER TO CHILD TRANSMISSION OF HIV (MTCT) IN AFRICAN WOMEN WITH HIV ROBERT GOLDENBERG1, WILLIAM ANDREWS1, TAHA TAHA2, WAFAIE FAWZI3, ELIZABETH BROWN4, 1University of Alabama at Birmingham, Obstetrics/ Gynecology, Birmingham, Alabama, 2Johns Hopkins University, Baltimore, Maryland, 3Harvard University, Boston, Massachusetts, 4Fred Hutchinson Cancer Research Center, Seattle, Washington OBJECTIVE: Cervical or vaginal FFN levels have been studied extensively in developed countries as a predictor of PTB. Our goal was to evaluate the relationship between FFN levels and gestational age (GA), birthweight (BWT) and MTCT of HIV in a large African population of predominately HIVinfected women. STUDY DESIGN: 2098 HIV-infected and 335 HIV-uninfected women participated in a randomized trial of antibiotics, (Metronidazole 250 mg and Erythromycin 250 mg tid ! 7 days at 20-24 wks and Metronidazole 250 mg and Ampicillin 500 mg q 4 hrs with onset of PROM or labor or identically appearing placebos) to reduce MTCT of HIV and PTB. (Antibiotics had no impact on either outcome.) Vaginal FFN samples were collected prior to antibiotic treatment and at approximately 28 wks, and quantitatively assayed. RESULTS: At 20-24 wks, 4.0% and at 26-30 wks, 4.9% of samples had R50 ng/ml FFN. FFN levels R50 ng/ml at 26-30 wks, but not 20-24 wks, were strongly associated with a variety of PTB outcomes: a decrease in mean BWT of 199g (p!0.0001), a 2 wk decrease in mean GA (p!0.0001); a 6-fold increase in PTB !32 wks (10.8 vs 1.9% p!0.001, OR=6.29 (3.19,12.3)); a 3fold increase in PTB !35 wks (26.1 vs 9.5% p!0.0001, OR=3.37 (2.15,5.26)); a 2-fold increase in PTB !37wks (38.7 vs 22.0% p!0.0001, OR=2.25 (1.51,3.33)); and a 2 week decrease in duration from randomization to delivery (p! 0.0001). As FFN levels rose from !50 to O200ng/ml, the higher the level of FFN, the higher the risk of poor PTB outcomes (most test of trends p!0.0001). FFN levels O50 ng/ml at 20-24 wks but not at 26-30 wks were associated with an increase in HIV MTCT (26.6 vs 15.3% p=0.03). Antibiotic treatment had no impact on FFN levels. CONCLUSION: High FFN levels at 26-30 but not at 20-24 wks were strongly associated with adverse outcomes including PTB and low BWT. The associations were stronger for early PTB, and were stronger when FFN levels were higher. At 20-24 wks, high FFN levels were associated with MTCT of HIV.