A comparative study of the safety and efficacy of FemCap, a new vaginal barrier contraceptive, and the Ortho All-Flex diaphragm. The FemCap Investigators' Group. Preoperative cervical dilatation: a trial of laminaria tents and prostaglandin F2 alpha gel. A comparison of osmotic dilators, Lamicel and Dilapan, and a prostaglandin E1 analogue, gemeprost, for ripening the cervix before legal abortion. Gemeprost versus misoprostol for cervical priming before first-trimester abortion: a randomized controlled trial. [Use of a new vaginal suppository: prostaglandin E1 analog Gemeprost for cervix maturation prior to abortion in the 1st trimester]. Cervical dilatation with 16,16-dimethyl-trans-delta 2-PGE1 methyl ester (Cervagem) prior to vacuum aspiration. A double-blind, placebo-controlled randomized study. Randomized comparison of different prostaglandin analogues and laminaria tent for preoperative cervical dilatation. World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction: Task Force on Prostaglandins for Fertility Regulation. Cervagem/Dilapan for preoperative cervical dilatation prior to vacuum aspiration for termination of first trimester pregnancy. A prospective randomized study. The role and comparison of two techniques of paracervical block for pain relief during suction evacuation for first-trimester pregnancy termination.
The FemCap is a new silicone rubber barrier contraceptive shaped like a sailor's hat, with a dome that covers the cervix, a rim that fits into the fornices, and a brim that conforms to the vaginal walls around the cervix. It was designed to result in fewer dislodgments and less pressure on the urethra than the cervical cap and diaphragm, respectively, and to require less clinician time for fitting. This was a phase II/III, multicenter, randomized, open-label, parallel group study of 841 women at risk for pregnancy. A subset of 42 women at one site underwent colposcopy. Women were randomized to use the FemCap or Ortho All-Flex contraceptive diaphragm, both with 2% nonoxynol-9 spermicide, for 28 weeks. The objectives were to compare the two devices with regard to their safety and acceptability and to determine whether the probability of pregnancy among FemCap users was no worse than that of the diaphragm (meaning not more than 6 percentage points higher). The 6-month Kaplan-Meier cumulative unadjusted typical use pregnancy probabilities were 13.5% among FemCap users and 7.9% among diaphragm users. The adjusted risk of pregnancy among FemCap users was 1.96 times that among diaphragm users, with an upper 95% confidence limit of 3.01. Clinical equivalence (noninferiority) of the FemCap compared with the diaphragm, as defined in this study, would mean that the true risk of pregnancy among FemCap users was no more than 1.73 times the pregnancy risk of diaphragm users. Because the observed upper 95% confidence limit (and even the point estimate) exceeded 1.73, the probability of pregnancy among FemCap users, compared with that among diaphragm users, did not meet the definition of clinical equivalence used in this study. The FemCap was believed to be safe and was associated with significantly fewer urinary tract infections. More women reported problems with the FemCap with regard to insertion, dislodgement, and especially removal, although their general assessments were positive. The two devices were comparable with regard to safety and acceptability, but a 6-point difference in the true 6-month pregnancy probabilities of the two devices could not be ruled out. Further studies are needed to determine whether design modifications can simplify insertion and removal. Surgical damage to the cervix in patients undergoing termination of pregnancy may be responsible for serious complications in subsequent pregnancies. Sixty nulliparous women undergoing first trimester termination of pregnancy were randomly allocated to 3 treatment groups, one using laminaria tents preoperatively, one using intracervical PGF2 alpha gel preoperatively and one using no pretreatment. Results showed clear benefits in the laminaria group, in terms of achieving preoperative cervical dilatation and ease of further operative dilatation. Laminaria tents were superior to PGF2 alpha gel which was, in turn, superior to no pretreatment. There were no differences in blood loss or postoperative complications among the 3 groups. Laminaria tents provide a cheap, effective and safe method of reducing the risk of cervical damage in women undergoing surgical termination of pregnancy. 66 primigravid women were allocated at random to receive either intravaginal application of the prostaglandin El analogue, gemeprost, or intracervical insertion of 1 of 2 osmotic dilators, Lamicel or Dilapan, 3 hours before legal abortion at 7-14 weeks gestation. Insertion of the dilators was not possible in 5 patients. All 3 methods were otherwise equally effective in achieving cervical dilatation and there was no difference in the need for or resistance to further dilatation between the 3 groups. Gemeprost was the most easily administered, and would be the most appropriate for routine preoperative use. To compare the efficacy of 400 microg of misoprostol with that of 1 mg of gemeprost as cervical priming agents when administered vaginally 3 to 4 hours before first-trimester vacuum aspiration abortion.
                In a prospective controlled trial 90 nulliparous women who requested termination of pregnancy before 12 weeks' gestation were randomized to receive vaginally either misoprostol or gemeprost for cervical priming. The force to dilate the cervix was measured by the use of a cervical tonometer connected to Hegar dilators from 3 to 10 mm. The main outcome measures were baseline cervical dilation; the peak force to dilate the cervix at 8, 9, and 10 mm; and the cumulative force to dilate the cervix to 10 mm.
                Baseline cervical dilation did not differ significantly between the women who received misoprostol and those who were treated with gemeprost. Neither the peak force required to dilate the cervix at 8, 9, and 10 mm nor the cumulative force to dilate the cervix to 10 mm showed any significant difference between the two groups.
                Vaginally administered misoprostol (400 microg) is as effective as gemeprost (1 mg) for cervical priming 3 to 4 hours before surgical termination of first-trimester pregnancies. This double-blind study is concerned with the efficacy and safety of a new prostaglandin E1-analogue (16,16'-dimethyl-trans-delta 2PGE1-methylester) (Gemeprost) (ONO-802), which was administered as a single 1 mg vaginal pessary three hours prior to legal abortion. The efficacy of the prostaglandin was assessed by the largest size of the dilator meeting no resistance when inserted in the cervical channel. Furthermore, the quality of the cervix and the effort needed for further dilatation was evaluated. The average size of the cervix prior to dilatation was found to be 10 mm, in comparison to only 7 mm in the placebo-group (p less than 0.001). 80% of the patients of the Gemeprost group did not need any further dilatation, i.e. the dilatation procedure of the cervix was easier than in the group without treatment (19%). The incidence of uterine pain was more frequent in the Gemeprost group (40%) than in the Placebo group (7%). Analgesics were not required. The frequency of gastrointestinal side effects was rare in the Gemeprost group (13%) and in the Placebo group (11%) compared with other prostaglandins. By the preoperative application of a new prostaglandin E1-analogue (1 mg) prior to vacuum aspiration in the first trimenon of pregnancy sufficient softening of the cervix and a dilatation of the cervix was achieved. It significantly reduces the need for further mechanical dilatation of the cervix as well as the force needed to perform this dilatation. These effects reduce the trauma associated with mechanical dilatation and therefore diminish the risk of subsequent complications. In the article are presented the results of a randomized double-blind study comparing the efficacy and tolerance of vaginal administration of 1.0 mg 16,16-dimethyl-trans-delta 2-PGE1 methyl ester and placebo as a pretreatment to vacuum aspiration for termination of pregnancy in nulliparae in the 8th to 12th weeks of gestation. One-hundred and-twenty-six patients fulfilled all the criteria for acceptance in the study and received either 1 mg of the E analogue or placebo three hours prior to vacuum aspiration. The mean cervical dilation at operation was following treatment with the E analogue 6.5 mm and with placebo 4.9 mm (p less than 0.001). The number of patients requiring no further mechanical dilation or the dilatation was considered easy was significantly higher in the prostaglandin-treated group than in the placebo group (p less than 0.001). The mean blood loss at operation was also higher in the placebo group (p less than 0.001). Uterine pain was slightly more common following prostaglandin treatment (p less than 0.05) while gastrointestinal side effects occurred equally often in both groups. In two patients the uterine wall was perforated, both perforations occurring in the placebo group. Late complication rates were comparable between the two groups. It can be concluded that pretreatment with the E analogue accomplishes sufficient dilatation and softening of the cervix in most patients. The efficacy of the procedure and its low frequency of side effects and complications make the procedure useful for cervical dilatation prior to vacuum aspiration in late first trimester pregnancy. In an eleven-centre study, 627 nulliparous subjects in the 8th to 12th week of gestation admitted for termination of pregnancy were allocated to one of five treatments to induce pre-operative cervical dilatation. The treatments were: 0.5 mg PGE2 methyl sulphonylamide; 1.0 mg PGE1 methyl ester; 30 mg 9-methylene PGE2 free acid, 0.5 mg 15-methyl PGF2 alpha; a single medium-sized laminaria tent. The results indicate that the three PGE analogues are at least equally effective as one medium sized laminaria tent and more effective than 0.5 mg 15-methyl PGF2 alpha in producing adequate pre-operative cervical dilatation prior to vacuum aspiration. It is concluded that both pre-treatment with prostaglandin analogues and laminaria tent are effective methods for preoperative cervical dilatation and both types of treatment are associated with a low incidence of side effects. Prostaglandin analogue treatment can be administered by paramedical personnel but laminaria tent insertion has to be performed by medical staff. The present study included 40 healthy nulliparous women admitted to the hospital for termination of first trimester pregnancy. The patients were randomly allocated to two study groups. One group was treated for 4 hours with one 1 mg Cervagem vaginal suppository prior to vacuum aspiration, the other was treated 4 hours with a Dilapan osmotic dilator intracervically. The patients were continuously supervised during treatment and after operation. Side effects and analgesic consumption were recorded. At operation the degree of cervical dilatation, blood loss and operative complications was registered. Dilapan was more effective and more uniform in dilating the cervix (p less than 0.05) and eventual further dilatation was easier (p less than 0.05). The blood loss was higher in the Dilapan-treated group (p less than 0.05). Side effects of postoperative pain and use of analgesic injections were higher in the Cervagem group (p less than 0.05). It is concluded that both methods are effective in dilating the cervix prior to vacuum aspiration, with Dilapan being the more effective dilator with the lower frequency of side effects. This prospective study assessed the role and compared two techniques of paracervical block (PCB) for pain relief during suction evacuation for first-trimester termination of pregnancy following cervical priming with misoprostol. One-hundred and thirty-five women undergoing suction evacuation up to 12 weeks of gestation were randomized into three groups: (a) 5 mL of 1% lignocaine injected at the 4 and 8 o'clock positions of the vaginal vault; (b) 5 mL of 1% lignocaine injected at the 4 and 8 o'clock positions of the cervix and (c) no PCB. Pain scores during PCB, cervical dilatation and during and after suction evacuation were compared among the three groups. The sedation and satisfaction levels were also compared. There were no statistically significant differences in the pain levels during PCB, cervical dilatation and suction evacuation and in the satisfaction levels among the three groups. Patients with a lighter sedation level experienced more pain. In conclusion, PCB did not improve the pain levels during first-trimester suction termination of pregnancy after cervical priming with misoprostol and use of intravenous sedation, regardless of whether the local anaesthetic was injected into the cervix or the vaginal vault.
The Prentif cap was as effective as its comparison diaphragm in preventing pregnancy, but the FemCap was not. Both cervical caps appear to be medically safe.