| Abstrakt: |
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. © 2001 Wiley Periodicals, Inc. J Biomed Mater Res (Appl Biomater) 63: 10–14, 2002 |
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