Efficacy of progesterone antagonist RU486 (mifepristone) for pre-operative cervical dilatation during first trimester abortion.

A randomized double-blind study (RU486 versus placebo) was carried out in order to investigate whether a progesterone antagonist facilitated surgical abortion in the first trimester of pregnancy. The consistency of the cervix changed significantly after RU486 (P less than 0.02). We conclude that this effect may facilitate cervical dilatation, making first trimester abortion under local anaesthesia more comfortable and less dangerous.

PIP: A randomized double-blind study was conducted in France in 1986-87 to determine whether 1st-trimester surgical abortion is facilitated by use of the progesterone antagonist RU 486. 64 healthy pregnant women with 6-12 weeks of amenorrhea were randomly assigned to receive either placebo or 200 mg/day of RU 486 for the 2 days preceding vacuum aspiration. The cervical modifications were assessed by calibration using Hegar's dilatators both 8 days before the procedure and on the day of vacuum aspiration. Subjects in the treatment and control groups did not differ significantly in terms of mean age (29.3 and 29.4 years, respectively), mean parity (1.1 and 1.4, respectively), or mean duration of amenorrhea (7.9 and 7.6 weeks, respectively). In the RU 486 group, mean cervical calibration was 3.4 + or - 1.3 mm before abortion and 5.5 + or - 1.9 mm after treatment. In the control group, mean cervical calibration changed from 3.2 + or - 1.1 mm to 4.1 + or - 1.4 mm before and after placebo administration. However, the mean calibration change was significantly higher in the RU 486 group (2.1 + or - 1.6 mm) than among controls (0.9 + or - 1.2 mm). 18 women in the treatment group, compared to only 1 in the placebo group, had uterine bleeding before pregnancy termination. None of these patients required blood transfusion or emergency curettage. RU 486 was well tolerated, with no recorded side effects. Given the significant effect on the consistency of the cervix and the potential reduced risk of traumatic complications, more widespread use of RU 486 is recommended in 1st-trimester abortion, especially in nulliparous women.

[The role of the progesterone antagonist, RU 486 (mifepristone), in preoperative cervical dilatation during the luteal phase. A randomized double-blind study]. / Place d'un antagoniste de la progesterone, RU 486 (mifepristone), en phase luteale avant la chirurgie endo-uterine. Resultat d'un essai therapeutique en double aveugle.

PIP: Endouterine surgery has become more common with the advent of operative hysteroscopy. It requires a preliminary dilatation of the cervix, which is usually achieved using rigid instruments. Cervical injury, uterine perforation, and other complications may occur in 2-5% of cervical dilatations for abortion and an unknown proportion in other uterine surgery. In as much as softening of the cervix has been observed in the 1st and 2nd trimesters of pregnancy after administration of sulprostone or of RU-486, a randomized double-blind study of RU-486 vs placebo was conducted to determine whether a progesterone antagonist could facilitate intrauterine surgery in the midluteal phase. 46 women undergoing hysterosurgery and laparoscopy under general anesthesia for idiopathic infertility were studied at the Antoine-Beclere Hospital in Clamart, France, between October 1987-October 1988. A placebo or 200 mg of RU=-486 was administered 2 days before surgery. For the 23 RU-486 and 23 placebo recipients respectively, the average ages were 31.2 and 32.5 years. 83% and 87% were consulting for primary infertility, and the average cycle day of surgery was 22.8 and 23.2. 6 women experienced spotting after RU-486 vs 1 in the placebo group. No undesirable secondary effects of complications were noted. No significant difference was seen in cervical consistency in the 2 groups. Average calibration evaluated with Hegar bougies was 5.15 for the RU-486 and 4.3 for the placebo group. A higher dose of RU-486 might have a greater cervical effect but would increase bleeding that would interfere with the hysteroscopy. No difference has been observed in the effect of RU- 486 administered in a single dose or divided into multiple doses. A change in the timing of RU-486 administration during the luteal phase and a shortening of the interval between RU-486 administration and surgery could be tested.^ieng

A comparison of cycle control and effect on well-being of monophasic gestodene-, triphasic gestodene- and monophasic desogestrel-containing oral contraceptives. Gestodene Study Group.

This was an open-label multicenter study to compare the cycle control and effect on well-being of two oral contraceptives containing gestodene and one containing desogestrel. A total of 2419 healthy women < or = 41 years of age were randomized to receive oral contraceptives containing monophasic gestodene (Minulet; n = 806, mean age 24.5 years), triphasic gestodene (Tri-Minulet; n = 808, mean age 24.6 years) or monophasic desogestrel (Mercilon; n = 805, mean age 24.6 years). Subjects were to participate in the study for up to 13 treatment cycles. A modified Moos Menstrual Distress Questionnaire was used to evaluate menstrual symptoms and to assess overall well-being. A total of 698 women were withdrawn from the study, 154 due to adverse events. Cycle control with gestodene was superior to that with desogestrel at almost all time points, particularly for breakthrough bleeding and/or spotting, which occurred significantly less frequently with gestodene than with desogestrel at cycles 1-7 and 9-11 (p < 0.05). Generally, the proportion of subjects with breakthrough bleeding and/or spotting was almost twice as great with desogestrel as with gestodene. The duration of bleeding was not consistently different between the gestodene and desogestrel groups; however, the intensity of bleeding was greater with gestodene at all time points (p < 0.05). The latent period before withdrawal bleeding was significantly longer for monophasic gestodene at cycles 1-5 and 8-10 (p < 0.05). Treatment significantly improved overall well-being at cycles 6 and 9 with triphasic gestodene and at cycle 13 with desogestrel; however, no statistically significant differences among treatment groups in overall well-being scores or individual factors of well-being could be identified. All three treatments were well tolerated. The most common drug-related adverse events were headache (14.2%), breast pain (6.2%), nausea (4.1%), metrorrhagia (3.9%) and abdominal pain (3.5%). The incidence of adverse events in all treatment groups was similar, with the exception of metrorrhagia, which occurred in more patients in the desogestrel group than in the gestodene treatment groups (p < 0.05).