This randomized controlled blind prospective study is undertaken to evaluate the safety and efficacy of
Seprafilm--a novel bioresorbable membrane of chemically modified
hyaluronic acid and
carboxymethylcellulose--in prevention and reduction of postoperative endometrial and endocervical synechiae formation after general suction evacuation or
curettage for incomplete, missed, and
recurrent abortion. In total, 150 patients with incomplete or
missed abortion participated in the clinical study. The study population was divided into two main groups. In the treatment (
Seprafilm) group (n=50), application of
Seprafilm membrane in the endometrial cavity and the cervical canal was used after the suction evacuation and/or the
curettage. In the control group (n=100), nothing was inserted in the uterus. Both groups were divided into two subgroups: patients who had no previous suction or
curettage, (with no previous D&C) (n=88), and patients who had at least one previous suction or
curettage (with one or more previous D&C) (n=62). In the treatment (
Seprafilm) group, 32 patients had no previous D&C and 18 patients had one or more previous D&C. In the control group, 56 patients had no previous D&C and 44 patients had one or more previous D&C. Further fertility was estimated by pregnancy success in all groups. Endometrial synechiae formation was evaluated with the use of hysterosalpingography (HSG) in patients of all groups without pregnancy success 8 months after the intervention. Registering any adverse reaction and performing ultrasound controls assessed the safety of
Seprafilm use. From the subgroup with no previous D&C, all 32 patients (100%) who received
Seprafilm had a pregnancy in the following 8 months; in the controls, pregnancy occurred only in 54%. It was also demonstrated with hysterosalpingography (HSG) that patients with one or more previous interventions and no pregnancy 8 months later were adhesion free in 90% of the patients where
Seprafilm was used, and only 50% in the untreated group. The membrane was tested on the endometrial area of the uterus and did not produce any adverse reaction. Ultrasound controls did not show any abnormal echoes. Intrauterine insertion of
Seprafilm is safe, prevents the appearance of endocervical adhesions or endometrial synechiae after
curettage, and reduces the area of the endometrial cavity occupied by them in a large percent of cases. It also seems that its use improves the possibility of a new pregnancy and fertility.