42 Oncofetal fibronectin in cervio-vaginal secretions is highly predictive of preterm delivery
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Volume 164 :-I umber l. P,lr! 39 EARLIER DETECTION OF PRE TERM LABOR: MULTICENTER PROSPECTIVE RANDOMIZED CLINICAL TRIAL OF HOME UTERINE ACTMlY MONITORING. Shiraz Sunderii, Stanley Gall, Susan Mou x , Helen HoW', Michael Corwinx. SUNY at Syracuse, U of lIIinois, Chicago, Truman Med Ctr, Kansas City, Boston U. A prospective randomized study was conducted to determine the value of home uterine activity monitoring (HUAM) in women at high risk for preterm delivery. 377 women with a Creasy Score of 10 or greater were randomly assigned to either HUAM plus standard high risk obstetrical care (Monitored Group = 198) or standard high risk obstetrical care alone (Not Monitored Group=179). Medical providers were blinded to group assignments. Both groups received identical education and care, except for twice daily uterine activity assessment using the Genesis R System. HUAM was not associated with any additional medical or nursing interventions. There were no differences in demographic, medical risk factors or number of routine or non-routine visits. Preterm Labor was observed in 42 (21%) monitored and 39 (22%) non-monitored women. MON(42) Not MON(39) P Value GA at Entry(wks) 26.6 25.8 GA at DX PTL(wks) 32.9 32.9 CX at DX (em) 1.38 2.5 .0006 Weeks Gained 3.7 2.0 .02 GA at Del(wks) 36.6 34.9 .009 Birthweight (gm) 2934.0 2329.0 .002 % in NICU 11.8 35.5 .038 Conclusion: HUAM allowed detection of preterm labor at an earlier phase. The clinical benefit of this is supported by increased gestational age and birthweight, and decreased need for NICU care. 40 ADJUNCTIVE CLiNDAMYCIN THERAPY FOR PRETERM LABOR: RESULTS OF A DOUBLE-BLINDED, RANDOMIZED, PLACEBO-CONTROLLED TRIAL. James A. McGregor, M,D.c'M., Janice I. French, c'N.M., M.S.,x Kyung Seo, M.D.X Department of Obstetrics and Gynecology, UCHSC, Denver, CO. Considerable information suggests that some instances of pre term birth are associated with clinically unrecognized reproductive tract infection. A double-blinded, placebo-controlled, randomized trial was conducted to evaluate the efficacy, safety, and tolerance of a defined course (7 days: 3 d IV; 4 d PO) of clindamycin among hospitalized women with preterm labor treated with tocolytics :':. 34 weeks gestation. 103 women/perinate pairs were analyzed. Antibiotic and placebo-treated women were similar. Clindamycin-treated women continued their pregnancies longer than women receiving placebo: C:35d, P:25d, p=0.02, Survival analysis demonstrated that 50% of clindamycin-treated women continued pregnancy at least 35.5 days vs. 20 days for control women, p=0.03. Women with bacterial vaginosis more often delivered preterm (p=.03, OR=3.2, 95% CI=1.06-9.6). Clindamycin treatment among women with BY showed trends for continued pregnancy (C:36d; P:19d), increased birthweight (C:2634 gms, P:2256 gms) and increased gestational age at delivery (C:35 wks, P:34 wks). Women with either group B streptococcus, C. trachoma tis, T. vaginalis, or S. aureuswere more likely to suffer preterm premature rupture of membranes (p=.OI). Clindamycin treatment was associated with reduced risk of PPROM amongst these women. Treatment with clindamycin appeared safe and well tolerated. Further studies are required to confirm and refine these findings among various groups of women. SPO Abstracts 259 41 GAP JUNCTION FORMATION IN HUMAN MYOMETRIUM-THE KEY TO PRETERM LABOR? James BalduCCI. BOriS Risekx, Norton B. Gilulax, Arthur Handx,James F.X. Egan, Anthony M. Vintzlleos. University of Connecticut Health Center, Farmington, CT and Scripps Institute, San Diego CA. The phYSiology of gap junctions has been studied in term pregnant sheep by electron microscopy. We hypotheSized that gap junctions are a necessary component of the human laboring uterus and their presence in myometrium IS a prerequisite for the occurrence of both term and preterm labor. In this study we have obtained 27 human myometrial samples(1cmx1cm) at the time of cesarean section or nongravld hysterectomy. Gap junction formation was studied in a blinded fashion by both freeze fracture and immunofluorescence techniques utiliZing at gap junction antibodies. Six were taken from term patients with no labor,6 from term patients In labor, 6 from preterm patients With no labor, 6 from patients in preterm labor, and 3 from nongravid hysterectomy specimens. The presence of gap junctions using freeze fracture technique was deSCribed as present/absent. Immunofluorescence was quantified utilizing computerized digital Image processing to assess relative gap Junction density. The results are as follows: Freeze Fracture Immunofluorescence mean dem'lf range Term- No labor (N=6) absent 0.65% (0-0.895%) Term-In labor (N=6) present 3.75% (1.6-6.1%) Preterm-No labor (N=6) absent 0.36% (0-0.94%) Preterm-In labor (N=6) present 4.56% (0.33-10.5%) Nongravid hysterectomy (N=3) absent 0.97% (0.73-1.2%) ThiS is the first study deSCribing human myometrial gap Junctions by using freeze fracture and immunofluorescence techniques Gap junction formation is present in the human myometrium of patients In term, as well as preterm labor. Gap junctions may be the final common pathway for the development of labor and the inhibition of gap junction actiVity could be a valuable new dimension In the treatment of preterm labor. 42 ONCOFETAL FIBRONECTIN IN CERVIO-VAGINAL SECRETIONS IS HIGHLY PREDICTIVE OF PRETERM DELIVERY. Thomas J. Garite, Charles Lockwood and Andrew Senyei. University of California, Irvine, Orange, California and Mt. Sinai School of MediCine, New York, New York Given the strong association between preterm labor and infection/inflammation, we evaluated the presence of a novel marker of decidual and chorionic extracellular matrix injUry with the risk for preterm delivery. Oncofetal fibronectin was measured in cervical and vaginal mucus (CV-onfFn) by ELISA in three groups of patients from 21 to 37 weeks. In uncomplicated pregnancies only 4% of patients (n=163) displayed CV-onfFn. In patients with preterm PROM, CV- onfFn was found in 94% (n=63), conSistent with the high levels of onfFn in amniotic fluid. Preterm labor patients with intact membranes (n=110) displayed CV-onfFn in 53% of cases and CV-onfFn identified patients destined to deliver prematurely with a sensitivity of 81 % and a specificity of 80%. Logistic regreSSion confirmed a strong correlation of CV-onfFn with preterm delivery (odds ratio=3.8, 95% CI:2.3-6.2, p=.0001). Even in patients with preterm contractions/intact membranes but cervical dilation CV-onfFn was highly predictive of preterm delivery. In thiS subgroup, 18/26 (69%) patients with positive CV-onfFn delivered prematurely, as compared to 8/44 (18%) with negative tests (sensitivity=69%, specificity=82%, odds ratio=3,2, CI:1.81-5.6, p=.001). We conclude that the presence of cervico-vaginal onfFn after 21 weeks is highly predictive of preterm delivery.
Transcript of 42 Oncofetal fibronectin in cervio-vaginal secretions is highly predictive of preterm delivery
Volume 164 :-I umber l. P,lr! ~
39 EARLIER DETECTION OF PRE TERM LABOR: MULTICENTER PROSPECTIVE RANDOMIZED CLINICAL TRIAL OF HOME UTERINE ACTMlY MONITORING. Shiraz Sunderii, Stanley Gall, Susan Moux, Helen HoW', Michael Corwinx. SUNY at Syracuse, U of lIIinois, Chicago, Truman Med Ctr, Kansas City, Boston U.
A prospective randomized study was conducted to determine the value of home uterine activity monitoring (HUAM) in women at high risk for preterm delivery. 377 women with a Creasy Score of 10 or greater were randomly assigned to either HUAM plus standard high risk obstetrical care (Monitored Group = 198) or standard high risk obstetrical care alone (Not Monitored Group=179). Medical providers were blinded to group assignments. Both groups received identical education and care, except for twice daily uterine activity assessment using the GenesisR System. HUAM was not associated with any additional medical or nursing interventions. There were no differences in demographic, medical risk factors or number of routine or non-routine visits. Preterm Labor was observed in 42 (21%) monitored and 39 (22%) non-monitored women.
MON(42) Not MON(39) P Value GA at Entry(wks) 26.6 25.8 GA at DX PTL(wks) 32.9 32.9 CX at DX (em) 1.38 2.5 .0006 Weeks Gained 3.7 2.0 .02 GA at Del(wks) 36.6 34.9 .009 Birthweight (gm) 2934.0 2329.0 .002 % in NICU 11.8 35.5 .038 Conclusion: HUAM allowed detection of preterm labor at an earlier phase. The clinical benefit of this is supported by increased gestational age and birthweight, and decreased need for NICU care.
40 ADJUNCTIVE CLiNDAMYCIN THERAPY FOR PRETERM LABOR: RESULTS OF A DOUBLE-BLINDED, RANDOMIZED, PLACEBO-CONTROLLED TRIAL. James A. McGregor, M,D.c'M., Janice I. French, c'N.M., M.S.,x Kyung Seo, M.D.X Department of Obstetrics and Gynecology, UCHSC, Denver, CO.
Considerable information suggests that some instances of pre term birth are associated with clinically unrecognized reproductive tract infection. A double-blinded, placebo-controlled, randomized trial was conducted to evaluate the efficacy, safety, and tolerance of a defined course (7 days: 3 d IV; 4 d PO) of clindamycin among hospitalized women with preterm labor treated with tocolytics :':. 34 weeks gestation. 103 women/perinate pairs were analyzed. Antibiotic and placebo-treated women were similar. Clindamycin-treated women continued their pregnancies longer than women receiving placebo: C:35d, P:25d, p=0.02, Survival analysis demonstrated that 50% of clindamycin-treated women continued pregnancy at least 35.5 days vs. 20 days for control women, p=0.03. Women with bacterial vaginosis more often delivered preterm (p=.03, OR=3.2, 95% CI=1.06-9.6). Clindamycin treatment among women with BY showed trends for continued pregnancy (C:36d; P:19d), increased birthweight (C:2634 gms, P:2256 gms) and increased gestational age at delivery (C:35 wks, P:34 wks). Women with either group B streptococcus, C. trachoma tis, T. vaginalis, or S. aureuswere more likely to suffer preterm premature rupture of membranes (p=.OI). Clindamycin treatment was associated with reduced risk of PPROM amongst these women. Treatment with clindamycin appeared safe and well tolerated. Further studies are required to confirm and refine these findings among various groups of women.
SPO Abstracts 259
41 GAP JUNCTION FORMATION IN HUMAN MYOMETRIUM-THE KEY TO PRETERM LABOR? James BalduCCI. BOriS Risekx, Norton B. Gilulax, Arthur Handx,James F.X. Egan, Anthony M. Vintzlleos. University of Connecticut Health Center, Farmington, CT and Scripps Institute, San Diego CA. The phYSiology of gap junctions has been studied in term pregnant
sheep by electron microscopy. We hypotheSized that gap junctions are a necessary component of the human laboring uterus and their presence in myometrium IS a prerequisite for the occurrence of both term and preterm labor. In this study we have obtained 27 human myometrial samples(1cmx1cm) at the time of cesarean section or nongravld hysterectomy. Gap junction formation was studied in a blinded fashion by both freeze fracture and immunofluorescence techniques utiliZing at gap junction antibodies. Six were taken from term patients with no labor,6 from term patients In labor, 6 from preterm patients With no labor, 6 from patients in preterm labor, and 3 from nongravid hysterectomy specimens. The presence of gap junctions using freeze fracture technique was deSCribed as present/absent. Immunofluorescence was quantified utilizing computerized digital Image processing to assess relative gap Junction density. The results are as follows:
Freeze Fracture Immunofluorescence mean dem'lf range
Term- No labor (N=6) absent 0.65% (0-0.895%) Term-In labor (N=6) present 3.75% (1.6-6.1%) Preterm-No labor (N=6) absent 0.36% (0-0.94%) Preterm-In labor (N=6) present 4.56% (0.33-10.5%) Nongravid hysterectomy (N=3) absent 0.97% (0.73-1.2%) ThiS is the first study deSCribing human myometrial gap Junctions by using freeze fracture and immunofluorescence techniques Gap junction formation is present in the human myometrium of patients In term, as well as preterm labor. Gap junctions may be the final common pathway for the development of labor and the inhibition of gap junction actiVity could be a valuable new dimension In the treatment of preterm labor.
42 ONCOFETAL FIBRONECTIN IN CERVIO-VAGINAL SECRETIONS IS HIGHLY PREDICTIVE OF PRETERM DELIVERY. Thomas J. Garite, Charles Lockwood and Andrew Senyei. University of California, Irvine, Orange, California and Mt. Sinai School of MediCine, New York, New York
Given the strong association between preterm labor and infection/inflammation, we evaluated the presence of a novel marker of decidual and chorionic extracellular matrix injUry with the risk for preterm delivery. Oncofetal fibronectin was measured in cervical and vaginal mucus (CV-onfFn) by ELISA in three groups of patients from 21 to 37 weeks. In uncomplicated pregnancies only 4% of patients (n=163) displayed CV-onfFn. In patients with preterm PROM, CVonfFn was found in 94% (n=63), conSistent with the high levels of onfFn in amniotic fluid. Preterm labor patients with intact membranes (n=110) displayed CV-onfFn in 53% of cases and CV-onfFn identified patients destined to deliver prematurely with a sensitivity of 81 % and a specificity of 80%. Logistic regreSSion confirmed a strong correlation of CV-onfFn with preterm delivery (odds ratio=3.8, 95% CI:2.3-6.2, p=.0001). Even in patients with preterm contractions/intact membranes but cervical dilation ~2cm, CV-onfFn was highly predictive of preterm delivery. In thiS subgroup, 18/26 (69%) patients with positive CV-onfFn delivered prematurely, as compared to 8/44 (18%) with negative tests (sensitivity=69%, specificity=82%, odds ratio=3,2, CI:1.81-5.6, p=.001). We conclude that the presence of cervico-vaginal onfFn after 21 weeks is highly predictive of preterm delivery.
