Randomized controlled study of pre-conception thromboprophylaxis among patients with recurrent spontaneous abortion related to antiphospholipid syndrome.

OBJECTIVES: To investigate the effects of pre-conception thromboprophylaxis among patients with recurrent spontaneous abortion and antiphospholipid syndrome. METHODS: A randomized placebo-controlled trial enrolled patients with a history of recurrent spontaneous abortions and antiphospholipid syndrome who attended an Egyptian center between January 2011 and June 2013. Using a computer-generated sequence, patients were randomly allocated to receive 41 mg enoxaparin subcutaneously plus 81 mg aspirin daily pre-conception, or to receive placebo pre-conception. All patients received enoxaparin and aspirin following identification of fetal heart pulsation. The primary outcomes were live-birth rate and clinical-pregnancy rate at 0-6 months, and at 6-12 months. Intention-to-treat analyses were performed. Clinicians, investigators, and data analysts were masked to the treatment assignments. RESULTS: The study enrolled 180 patients(90 in each group). No significant difference was observed between the intervention and control groups in the live-birth rate (67[74%] vs 59[66%]; P=0.25). At 0-6 months, the clinical-pregnancy rate was higher in the intervention group (50[56%]vs 30[33%], P=0.02). No significant difference between the intervention and control groups was observed in the clinical-pregnancy rate at 6-12 months (32[36%] vs 35[39%], P=0.52). CONCLUSION: Among patients with recurrent spontaneous abortion and antiphospholipid syndrome, pre-conception enoxaparin increased the clinical-pregnancy rate at 0-6 months, but did not affect the clinical-pregnancy rate at 6-12 months or the live-birth rate. ClinicalTrials.gov: NCT01661439.

Safety and efficacy of postoperative continuous intra-peritoneal wash with lactated Ringer's for minimizing post-myomectomy pelvic adhesions: a pilot clinical trial.

OBJECTIVES: To assess efficacy and safety of post-operative intra-peritoneal wash with lactated Ringer's for 48h after myomectomy in reduction of adhesions compared to routine intra-operative irrigation. Study design A prospective, randomized trial that included 52 eligible participants who had undergone abdominal myomectomy. Participants were randomly allocated to a treatment group (n=26) which was subjected to continuous peritoneal wash for 48h via two intraperitoneal drains, and a control group (n=26). The incidence of de novo adhesions and their severity and extent were scored at a second-look laparoscopy 8-10 weeks postoperatively. Adhesions were graded using the local adhesion barrier scoring system score. Adverse effects were also assessed and reported. RESULTS: There was no statistically significant difference in duration of hospital stay or in the incidence of adverse events. A significantly higher proportion of adhesion-free patients was found in the treatment group [11/23, 47.8%] compared to the control group [4/21, 19%] (P<0.01). The mean number of pelvic sites covered by adhesions was significantly lower in the treatment group than in the control group (2.2±0.3 versus 4.6±0.8, P<0.05). The total adhesion score was significantly lower in the treatment group than in the control group (2.1±0.5 versus 4.8±1.4, P<0.05) and the adhesion score was significantly lower at most of the individual anatomical sites. CONCLUSIONS: Application of postoperative intraperitoneal wash with lactated Ringer's solution for 48h may have reasonable safety and efficacy in minimizing postoperative pelvic de novo adhesions following abdominal myomectomy.

Pregnancy outcomes of expectant management of stable mild to moderate chronic hypertension as compared with planned delivery.

OBJECTIVE: To compare outcomes between elective delivery at 37 weeks of pregnancy and expectant management among pregnant women with mild to moderate chronic hypertension. METHODS: In a two-center study, 76 women with mild to moderate chronic hypertension were randomly allocated to planned delivery at 37 completed weeks (group A) or expectant management for spontaneous onset of labor or reaching 41 weeks (group B) between April 2012 and October 2013. Differences were compared by t test, χ(2) test, or Fisher exact test. Odds ratios (ORs) with 95% confidence interval (CIs) were determined. RESULTS: There were no differences in superimposed pre-eclampsia (SPE), severe hypertension, preterm delivery, placental abruption, oligohydramnios, intrauterine growth restriction, or perinatal mortality between the groups. Group B had higher gestational age at delivery (P=0.001) and birth weight (P=0.01), but lower cesarean (OR 3.4; 95% CI, 1.2-10.3; P=0.03) and neonatal care unit admission (OR 5.4; 95% CI, 1.4-21.0; P=0.01) rates. More women with SPE were diagnosed before than after 37 weeks in group B (P=0.01). Overall, patients who developed SPE had more adverse pregnancy outcomes than those who did not. CONCLUSION: Mild to moderate chronic hypertension could be managed expectantly up to 41 weeks if SPE did not develop.