Abstract

Artificial ripening of the unfavorable cervix was attempted in 69 patients by a newly designed double balloon catheter, placed in the cervix for 12 hours. The balloons, such inflated to 40 ml, covered the internal and external cervical os, with the catheter's opening located between them, in the endocervical canal. The study was carried out in three phases. In the first phase, 22 term pregnant women received intracervical PGE2 gel through the catheter with two inflated balloons confining the gel to the cervix. The second phase consisted of a double blind randomized controlled study, where, through the double balloon catheter, ten women received PGE2 gel and another ten were given placebo gel. The third phase consisted of an open study of inserting the catheter alone, without PGE2, and inflation of the balloons in 27 patients. A substantial mean increases in the Bishop Score was noted in all these phases.