Effects of tranexamic acid on platelet function and thrombin generation (ETAPlaT): WOMAN trial sub-study.

Background. Postpartum haemorrhage (PPH) is a leading cause of maternal death. Tranexamic acid (TXA) has the potential to reduce bleeding and a large randomized placebo controlled trial of its effect in women with PPH (The WOMAN trial) is underway. TXA might also affect coagulation factors and platelets.  Objectives. To examine the effect of TXA on thrombin generation, platelet function, fibrinogen, D-dimer and coagulation factors in women with PPH.  Methods. We will conduct a sub-study within the WOMAN trial. Women with clinically diagnosed primary PPH after vaginal or caesarean delivery are eligible for inclusion. Blood samples will be collected at baseline and 30 minutes after the first dose of study treatment. Using platelet poor plasma we will measure thrombin generation, fibrinogen, D-dimer, factor V and VIII, and Von Willebrand factor. Platelet function will be evaluated in whole blood using Multiplate® tests. Outcomes. The primary outcome is the effect of TXA on thrombin generation. Secondary outcomes include the effect of TXA on platelet function, fibrinogen, D-dimer and coagulation factors.

Prenatal detection of cardiac anomalies in fetuses with single umbilical artery: diagnostic accuracy comparison of maternal-fetal-medicine and pediatric cardiologist.

AIM: To determine agreement of cardiac anomalies between maternal fetal medicine (MFM) physicians and pediatric cardiologists (PC) in fetuses with single umbilical artery (SUA). METHODS: A retrospective review of all fetuses with SUA between 1999 and 2008. Subjects were studied by MFM and PC, delivered at our institution, and had confirmation of SUA and cardiac anomaly by antenatal and neonatal PC follow-up. Subjects were divided into four groups: isolated SUA, SUA and isolated cardiac anomaly, SUA and multiple anomalies without heart anomalies, and SUA and multiple malformations including cardiac anomaly. RESULTS: 39,942 cases were studied between 1999 and 2008. In 376 of 39,942 cases (0.94%), SUA was diagnosed. Only 182 (48.4%) met inclusion criteria. Cardiac anomalies were found in 21% (38/182). Agreement between MFM physicians and PC in all groups combined was 94% (171/182) (95% CI [89.2, 96.8]). MFM physicians overdiagnosed cardiac anomalies in 4.4% (8/182). MFM physicians and PC failed to antenatally diagnose cardiac anomaly in the same two cases. CONCLUSIONS: Good agreement was noted between MFM physicians and PC in our institution. Studies performed antenatally by MFM physicians and PC are less likely to uncover the entire spectrum of cardiac abnormalities and thus neonatal follow-up is suggested.

The value of the middle cerebral to umbilical artery Doppler ratio in the prediction of neonatal outcome in patient with preeclampsia and gestational hypertension.

OBJECTIVE: To investigate the diagnostic value of MCA/UA pulsatility index ratio for the prediction of adverse perinatal outcome in the fetuses with preeclampsia and gestational hypertension. MATERIALS AND METHODS: We included in the study 738 patients recovered in our Hospital with the diagnosis of preeclampsia and gestational hypertension, from January 2006 to December 2009. All the patients underwent accurate color Doppler velocimetry examination. The study population was divided into two groups depending on the normal or abnormal values of MCA/UA pulsatility index ratio.Outcome variables were intrauterine and early neo natal death, admission to the neonatal intensive care unit and the duration of treatment, Apgar score below 7 at 5 minutes,cesarean delivery for fetal distress, gestational age at delivery, neonatal birth weight, IUGR. RESULTS: We divided the study population into two groups depending on normal or abnormal value of MCA/UA pulsatility index ratio. In 314 patients we found abnormal values of MCA/UA pulsatility index ratio. Neonates of mothers with abnormal values of MCA/UA pulsatility index ratio had significantly lower gestational age at delivery (34.8 versus 38.4, P<0.0001), lower birth weight (2174.6 g versus 3215.0g, P<0.001), significantly greater risk for perinatal death (30.8% versus 0.23%, P<0.0001) significantly greater risk of admission to intensive care unit (77.8% versus 47.4%, P<0.0001), longer duration of treatment in NICU (10.6 days versus 6.5 days, P<0.0001), greater rate of cesarean delivery for fetal distress (76.7% versus 62.5%,P<0.0001), a great number of neonates with low Apgar score at 5 minute (61.9% versus 22.4%, P<0.0001) greater rate of cesarean delivery for fetal distress (71.9% versus 62.5%,P<0.0001), a great number of fetuses IUGR (7.18% versus 1.76%,P<0.0001). CONCLUSION: ACM/UA pulsatility index ratio is a very good predictor of adverse outcome in the fetuses of women with preeclampsia and gestational hypertension.

Prevalence of gestational trophoblastic disease in ectopic pregnancy.

OBJECTIVE: To describe the prevalence of gestational trophoblastic disease in ectopic pregnancy. STUDY DESIGN: Medical records of 105 patients from January 2007 to October 2009. We excluded of the study 5 cases (one case where the answer of the biopsy was not clear; 4 others with diagnosis of adhnexial mass where the pregnancy test had resulted positive but the answer of biopsy have been resulted ruptured ovary cyst and pyosalpingitis). So definitely the size of the sample was 100 patients. RESULTS: 79 patients with EP underwent surgery due to a (diagnosis of EP with hem peritoneum and enraptured ectopic pregnancy) and in 18 of them the answer of the biopsy was GTD. 4 of 75 cases admitted in our hospital with diagnosis of EP, (pregnancy test was used instead of estimation of the level of ß-hCG because our hospital couldn't offer estimation of the level of ß-hCG during 24 hours) have been not confirmed diagnosis of EP by biopsy, but ruptured ovary cyst with hem peritoneum, pyosalpingitis.31 cases with EP (enraptured EP) underwent medical treatment with methotroxate. In 10 cases last management was failed and surgical intervention was institutionalized and histological analysis revealed GTD in 6 of them (partial mole). ß-hCG level was detected in 31 cases with enraptured fallopian pregnancy; in all cases where treatment with methotroxate has been failed and GTD was confirmed, the level of ß-hCG was > 10.234 mUI/ml. 21 cases with enraptured fallopian pregnancy were successfully treated, and at this point we never learned the answer of biopsy. We registered one case with cervical pregnancy and one cornual (interstitial portion) pregnancy. CONCLUSION: we found 18 cases of GTD in EP /11.500 deliveries (1,56 per 1,000 deliveries), prevalence of the GTD in EP was about 18%.

Mifepristone medical abortion in Albania: results from a pilot clinical research study.

OBJECTIVE: To explore the acceptability and feasibility of introducing mifepristone-misoprostol for early medical abortion in home and clinic settings in Albania. METHODS: This was a prospective study testing a simplified mifepristone-misoprostol regimen in two tertiary-level government health facilities in Tirana, Albania. Women (n = 409) with amenorrhea of 8 weeks or less received 200 mg mifepristone in the clinic and then chose whether to take 400 microg of oral misoprostol 2 days later either at home or in the clinic. RESULTS: Nearly 97% of women successfully terminated their pregnancies using the simplified regimen. Almost all women found the method either satisfactory (49.4%) or highly satisfactory (41.1%). Almost all women who were given the option selected the home use protocol. Women choosing home administration of misoprostol were able to manage the medical abortion process on their own. CONCLUSION: A reduced dose mifepristone medical abortion regimen with home administration of misoprostol is feasible for introduction into healthcare facilities in Albania.