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O140 Alternatives to routine ultrasound for eligibility assessment prior to early medical abortion
Free communication (oral) presentations / International Journal of Gynecology & Obstetrics 107S2 (2009) S93–S396
Conclusions: The PASS Stillbirth Classification incorporates mechanism of demise and etiology to address pathophysiology of stillbirth. In these 21 stillbirths, 25% were due to fetal disorders, 50% to placental etiologies, and 25% were of unknown cause. 43% of cases were due placental perfusion failure with an a priori risk for recurrence. This schema will be applied to stillbirths from Phase II pregnancies (n = 12,000) in the PASS Research Network. We hypothesize effects of prenatal alcohol and smoking exposure on pregnancy may modify case stratification and/or demonstrate a concentrated effect in certain stillbirth subsets. O140 Alternatives to routine ultrasound for eligibility assessment prior to early medical abortion H. Bracken1 , W. Clark1 , J. Tanenhaus2 , S. Schweikert3 , S. Lichtenberg4 , B. Winikoff1 . 1 Gynuity Health Projects, USA, 2 Planned Parenthood of New York City, USA, 3 Planned Parenthood of San Diego Riverside, USA, 4 Family Planning Associates Medical Group, Chicago, USA Objective: To test the feasibility and efficacy of an approach to medical abortion that foregoes routine use of ultrasound for determination of eligibility for medical abortion. Methods: The prospective multi-center trial enrolled 4484 women seeking medical abortion at ten family planning clinics in the United States. Women provided estimates of date of last menstrual period. Women also underwent an ultrasound and clinical exam. We compared estimates using the three methods, calculating the proportion of women less than or equal to 9 weeks gestation by woman or provider estimate and greater than 9 weeks by ultrasound. Results: Relying on women’s report of last menstrual period alone, only 3.3% of women would have been offered treatment despite being beyond 9 weeks gestation, the traditional cutoff for early medical abortion protocols. Relying on women’s report of LMP along with physical examination to determine eligibility for medical abortion would result in only 1.6% of women being offered medical abortion treatment at an “inappropriate” gestational age. However, any woman inappropriately offered treatment would have been at a gestational age when medical abortion treatment would still be extremely likely to be successful. Conclusion: It is possible safely to forego routine pre-abortion sonography in order to determine women’s eligibility for medical abortion. O141 Alternatives to a routine follow-up visit for early medical abortion W. Clark1 , H. Bracken1 , J. Tanenhaus2 , L. Lang3 , S. Lichtenberg4 , B. Winikoff1 . 1 Gynuity Health Projects, 2 Planned Parenthood of New York City, 3 Planned Parenthood of San Diego Riverside, 4 Family Planning Associates Medical Group Background: Typical protocols for early medical abortion with mifepristone and misoprostol require women to return to the clinic 7–14 days after the administration of mifepristone. Many practitioners employ trans-vaginal ultrasonic imaging at the followup visit to verify the abortion is complete. This study evaluated the ability of women and their providers to assess the need for additional care without the routine use of ultrasound or a followup clinic visit. Methods: The prospective multi-center trial enrolled 4484 women seeking medical abortion at ten family planning clinics in the United States. Data were collected on women’s sociodemographic characteristics; abortion outcomes and receipt of additional treatment (including ongoing pregnancy, curettage, treatment for infection, or receipt of additional uterotonics); and clinical, laboratory and ultrasound assessments associated with the procedure.
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Results: Of the 3377 treated women not lost to follow-up who received treatment at or after the follow-up visit, 22 women (0.7%) were diagnosed with an ongoing pregnancy. Thirty-three women (1.4%) received curettage or treatment for a suspected infection and 55 women (2.6%) received additional uterotonics or other medical abortion-related care. A screening algorithm based on two patientobserved outcomes, a urine test, and non-sonographic clinical evaluation performed as well as sonography, identifying at least as large a percentage of women with ongoing pregnancies or who received curettage or treatment for infection at the follow-up visit. Data also suggest that a safe, effective algorithm relying on womanobserved parameters alone might be developed which could spare many patients the necessity of returning for a follow-up visit. Conclusion: Relying on women’s observations, a low-sensitivity pregnancy test, and clinical examination, women and their providers can accurately assess whether a woman requires further follow-up care after medical abortion with mifepristonemisoprostol without ultrasound. O142 Expression of the cell-cycle regulators p21, p16 and p53 in cervical intraepithelial neoplasia J. Braganca, ¸ S. Derchain, D. Pitta, A. Maito, J. Vassallo, G. Pinto, L. Andrade, L. Sarian. Faculdade de Ciencias M´edicas, Universidade Estadual de Campinas UNICAMP Objective: To assess the expression of the cell-cycle regulators p21, p16 and p53 in cervical intraepithelial neoplasia grades I to III. Materials and Methods: In this cross-sectional study, we examined histological samples from 102 women who underwent cervical conization between March 2003 and November 2007. The expression of the cell-cycle regulators was determined with immunohistochemistry. Analysis of covariance (CANOVA) was used to determine the differences in expression of each of the cell-cycle regulators in different grades of CIN, controlled for relevant clinical features of the women. Paired t-tests and Pearson’s correlation coefficients were used to determine the association between the expressions of the cell-cycle regulators. Results: Pathological assessment disclosed 79 (77.4%) cases of CIN 3, 12 (11.8%) of CIN 2 and 11 (10.8%) CIN 1. The expression of p21 and p53 were not associated with CIN grade (p = 0.09 and p = 0.89, respectively), whereas that of p16 increased in parallel with disease severity (p < 0.01). The expression of p16 and p21 showed no statistical correlation (p = 0.64, cor = 0.04), as neither that of p21 and p53 (p = 0.10, cor = 0.17) nor of p16 and p53 (p = 0.87, cor = 0.02). Conclusions: The expressions of the cell-cycle regulators p21, p53 and p16 were not associated to each other in CIN, and p16 was the only marker that had its expression associated with CIN grade. O143 The effectiveness of the SOS Bakri Balloon in controlling post partum hemorrhage unresponsive to medical therapy in a community hospital in Edmonton, Alberta G. Brassard, T. Corbett. University of Alberta, Edmonton, Canada Objective: To examine the effectiveness of the SOS Bakri balloon in controlling post partum hemorrhage (PPH) refractory to medical treatment. Methods: A retrospective case review of 19 events of post partum hemorrhage that failed to respond to medical therapy in a community based hospital in Edmonton, Canada. Charts were selected by convenience sampling if they met the ICD10-CA codes of uterine packing and control or excision of bleeding uterus and surrounding structures. Exclusion criteria included women who delivered at less than 24 weeks of gestational age and charts with incomplete data. Results: The SOS Bakri balloon was successful in stopping hemorrhage in 16/19 cases. Average patient age was 28 and average parity was 1. There were three sets of twins and 16 singletons. The
Conclusions: The PASS Stillbirth Classification incorporates mechanism of demise and etiology to address pathophysiology of stillbirth. In these 21 stillbirths, 25% were due to fetal disorders, 50% to placental etiologies, and 25% were of unknown cause. 43% of cases were due placental perfusion failure with an a priori risk for recurrence. This schema will be applied to stillbirths from Phase II pregnancies (n = 12,000) in the PASS Research Network. We hypothesize effects of prenatal alcohol and smoking exposure on pregnancy may modify case stratification and/or demonstrate a concentrated effect in certain stillbirth subsets. O140 Alternatives to routine ultrasound for eligibility assessment prior to early medical abortion H. Bracken1 , W. Clark1 , J. Tanenhaus2 , S. Schweikert3 , S. Lichtenberg4 , B. Winikoff1 . 1 Gynuity Health Projects, USA, 2 Planned Parenthood of New York City, USA, 3 Planned Parenthood of San Diego Riverside, USA, 4 Family Planning Associates Medical Group, Chicago, USA Objective: To test the feasibility and efficacy of an approach to medical abortion that foregoes routine use of ultrasound for determination of eligibility for medical abortion. Methods: The prospective multi-center trial enrolled 4484 women seeking medical abortion at ten family planning clinics in the United States. Women provided estimates of date of last menstrual period. Women also underwent an ultrasound and clinical exam. We compared estimates using the three methods, calculating the proportion of women less than or equal to 9 weeks gestation by woman or provider estimate and greater than 9 weeks by ultrasound. Results: Relying on women’s report of last menstrual period alone, only 3.3% of women would have been offered treatment despite being beyond 9 weeks gestation, the traditional cutoff for early medical abortion protocols. Relying on women’s report of LMP along with physical examination to determine eligibility for medical abortion would result in only 1.6% of women being offered medical abortion treatment at an “inappropriate” gestational age. However, any woman inappropriately offered treatment would have been at a gestational age when medical abortion treatment would still be extremely likely to be successful. Conclusion: It is possible safely to forego routine pre-abortion sonography in order to determine women’s eligibility for medical abortion. O141 Alternatives to a routine follow-up visit for early medical abortion W. Clark1 , H. Bracken1 , J. Tanenhaus2 , L. Lang3 , S. Lichtenberg4 , B. Winikoff1 . 1 Gynuity Health Projects, 2 Planned Parenthood of New York City, 3 Planned Parenthood of San Diego Riverside, 4 Family Planning Associates Medical Group Background: Typical protocols for early medical abortion with mifepristone and misoprostol require women to return to the clinic 7–14 days after the administration of mifepristone. Many practitioners employ trans-vaginal ultrasonic imaging at the followup visit to verify the abortion is complete. This study evaluated the ability of women and their providers to assess the need for additional care without the routine use of ultrasound or a followup clinic visit. Methods: The prospective multi-center trial enrolled 4484 women seeking medical abortion at ten family planning clinics in the United States. Data were collected on women’s sociodemographic characteristics; abortion outcomes and receipt of additional treatment (including ongoing pregnancy, curettage, treatment for infection, or receipt of additional uterotonics); and clinical, laboratory and ultrasound assessments associated with the procedure.
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Results: Of the 3377 treated women not lost to follow-up who received treatment at or after the follow-up visit, 22 women (0.7%) were diagnosed with an ongoing pregnancy. Thirty-three women (1.4%) received curettage or treatment for a suspected infection and 55 women (2.6%) received additional uterotonics or other medical abortion-related care. A screening algorithm based on two patientobserved outcomes, a urine test, and non-sonographic clinical evaluation performed as well as sonography, identifying at least as large a percentage of women with ongoing pregnancies or who received curettage or treatment for infection at the follow-up visit. Data also suggest that a safe, effective algorithm relying on womanobserved parameters alone might be developed which could spare many patients the necessity of returning for a follow-up visit. Conclusion: Relying on women’s observations, a low-sensitivity pregnancy test, and clinical examination, women and their providers can accurately assess whether a woman requires further follow-up care after medical abortion with mifepristonemisoprostol without ultrasound. O142 Expression of the cell-cycle regulators p21, p16 and p53 in cervical intraepithelial neoplasia J. Braganca, ¸ S. Derchain, D. Pitta, A. Maito, J. Vassallo, G. Pinto, L. Andrade, L. Sarian. Faculdade de Ciencias M´edicas, Universidade Estadual de Campinas UNICAMP Objective: To assess the expression of the cell-cycle regulators p21, p16 and p53 in cervical intraepithelial neoplasia grades I to III. Materials and Methods: In this cross-sectional study, we examined histological samples from 102 women who underwent cervical conization between March 2003 and November 2007. The expression of the cell-cycle regulators was determined with immunohistochemistry. Analysis of covariance (CANOVA) was used to determine the differences in expression of each of the cell-cycle regulators in different grades of CIN, controlled for relevant clinical features of the women. Paired t-tests and Pearson’s correlation coefficients were used to determine the association between the expressions of the cell-cycle regulators. Results: Pathological assessment disclosed 79 (77.4%) cases of CIN 3, 12 (11.8%) of CIN 2 and 11 (10.8%) CIN 1. The expression of p21 and p53 were not associated with CIN grade (p = 0.09 and p = 0.89, respectively), whereas that of p16 increased in parallel with disease severity (p < 0.01). The expression of p16 and p21 showed no statistical correlation (p = 0.64, cor = 0.04), as neither that of p21 and p53 (p = 0.10, cor = 0.17) nor of p16 and p53 (p = 0.87, cor = 0.02). Conclusions: The expressions of the cell-cycle regulators p21, p53 and p16 were not associated to each other in CIN, and p16 was the only marker that had its expression associated with CIN grade. O143 The effectiveness of the SOS Bakri Balloon in controlling post partum hemorrhage unresponsive to medical therapy in a community hospital in Edmonton, Alberta G. Brassard, T. Corbett. University of Alberta, Edmonton, Canada Objective: To examine the effectiveness of the SOS Bakri balloon in controlling post partum hemorrhage (PPH) refractory to medical treatment. Methods: A retrospective case review of 19 events of post partum hemorrhage that failed to respond to medical therapy in a community based hospital in Edmonton, Canada. Charts were selected by convenience sampling if they met the ICD10-CA codes of uterine packing and control or excision of bleeding uterus and surrounding structures. Exclusion criteria included women who delivered at less than 24 weeks of gestational age and charts with incomplete data. Results: The SOS Bakri balloon was successful in stopping hemorrhage in 16/19 cases. Average patient age was 28 and average parity was 1. There were three sets of twins and 16 singletons. The