Authors A.M. Badawy, M. Khiary, L. S. Sherif, M. Hassan, A. Ragab, I. Abdelall
Journal Journal of de Obstetrics and Gynecology
Year of publication 2008
Country Egypt
Period From February, 2003 to January, 2006
Study Designer Prospective randomized study
Randomization Women were randomly allocated to either group A (thromboprophylaxis group, n=170) or group B (control group n=170) using pre-filled sealed envelopes designed by the investigators for each patient.
Inclusion criteria Pregnant women before 8 weeks of gestation with a history of three or more consecutive first trimester abortion (first 12 weeks of gestation) with no identifiable etiology after full investigations. Habitual abortion was defined as a history of three or more consecutive abortions in the first trimester.
Exclusion criteria Women with any identifiable etiology for spontaneous abortions, such as hereditary thrombophilia.
Participant demographic data There are no significant differences between the two groups. The age of the patients in the study ranged from 18 to 36 years. A total of 52 patients (30.5%) in group A and 45 patients (26.4%) in group B had deliveries before completing the full term. There was a high incidence of pre-pregnancy complications such as fetal loss (12-21 weeks), preeclampsia, placental detachment, small for gestational age and fetal birth, but without significant differences between the two groups.
Types of interventions Group A: Low molecular weight heparin prescribed (enoxaparin sodium 0.2 ml, 20 mg once daily subcutaneously, Clexane®, Aventis Pharma, Egypt) from the time of ultrasonographic confirmation of fetal viability up to 34-week pregnancy and folic acid tablets 0.5 mg daily up to 13 weeks gestation. Platelet counts and activated partial thromboplastin time (usually 25-35 weeks) were performed 10 to 20 days from the start of treatment and every month thereafter until 34 weeks of gestation. Group B: Folic acid prescribed 0.5 mg tablets daily up to 13 weeks of gestation. Prenatal visits were made for all patients every 2 weeks until the first 20 weeks and then every 4 weeks until 36 weeks and then every week until delivery. During prenatal visits, obstetric ultrasound and laboratory investigation were performed for all patients.
Results measures End of pregnancy and its results
Results LMWH appears to be a safe and effective drug in significantly reducing the incidence of recurrent miscarriages of unknown etiology when administered in the first trimester and continued throughout pregnancy.