Medical abortion in women of less than or equal to 56 days amenorrhoea: a comparison between gemeprost (a PGE1 analogue) alone and mifepristone and gemeprost.

OBJECTIVE: To determine the efficacy of a new dose regimen of vaginal gemeprost (1 mg every 6 h up to three doses) in induction of abortion in women less than or equal to 56 days gestation, and to compare this regimen with mifepristone (200-600 mg) followed 48 h later by a single dose of gemeprost (1 mg). DESIGN: Two separate protocols, with 50% of the subjects randomized to one or other protocol. SETTING: The Royal Infirmary of Edinburgh, Scotland, UK. SUBJECTS: 301 referred by their general practitioner or local family planning clinic, requesting termination of pregnancy at less than or equal to 56 days amenorrhoea. INTERVENTIONS: Ongoing pregnancies and incomplete abortions were terminated surgically. MAIN OUTCOME MEASURES: Number of complete abortions, analgesic requirements and bleeding pattern following treatment. RESULTS: Complete abortion occurred in 87% of women treated with gemeprost alone and 98% of women treated with mifepristone and gemeprost (P = 0.0004). Analgesic requirements were greater in the group treated with gemeprost alone, compared with the group treated with mifepristone and gemeprost (P = 0.0001). CONCLUSION: The new dose regimen of gemeprost can be used for early induced abortion, but the use of mifepristone and gemeprost has several advantages over the use of gemeprost alone.     

A comparison of lamicel tents and gemeprost (Cervagem) pessaries prior to first trimester abortion

Summary In an open, randomized study 108 women were treated with either a Lamicel tent or a 1 mg gemeprost pessary (Cervagem) 4 h before first trimester abortion. Both treatments were effective in producing cervical dilatation, however further dilatation was significantly easier after Cervagem. Preoperative abdominal pain and gastrointestinal side-effects were significantly more frequent in the Cervagem group. The incidence of postoperative pain and blood loss were similar in the two groups. Advantages and disadvantages of the two treatments are mentioned.     

Pre-operative cervical preparation before first trimester vacuum aspiration: a randomized controlled comparison between gemeprost and mifepristone (RU 486).

OBJECTIVE--To compare the effectiveness of 200 mg mifepristone with 1 mg gemeprost vaginal pessary in achieving cervical dilatation and softening ('priming') before late first trimester pregnancy vacuum aspiration. DESIGN--A randomized, operator blind, placebo controlled trial. SETTING--UK teaching hospital. SUBJECTS--90 primigravid women with 63-91 days amenorrhoea and ultrasonically confirmed single living fetus of correct size for gestational age. INTERVENTIONS--The women were allocated to receive 200 mg mifepristone orally or an identical oral placebo 36 h before operation or 1 mg gemeprost vaginal pessary 3-4 h preoperatively. MAIN OUTCOME MEASURES--Onset of new symptoms following drug administration, a proven objective measure of the force required to dilate the cervix, and estimated intraoperative blood loss. RESULTS--There were no significant differences in the baseline cervical dilatation, the force required to dilate the cervix or the volume of intraoperative blood loss between the active treatment groups. Both drugs were significantly more effective than placebo. Significantly fewer women in the mifepristone group had adverse side effects than in the gemeprost group. CONCLUSIONS--Mifepristone is a highly effective cervical priming agent, and has the advantages of being an oral preparation associated with few side effects.     

Unsuccessful treatment of missed abortion with a combination of an antiprogesterone and a prostaglandin E1 analogue

In a prospective clinical trial the effectiveness of a combination of 400 mg of mifepristone (antiprogesterone) and 400 g misoprostol (synthetic prostaglandin E₁ analogue), both taken orally, was evaluated for the treatment of missed abortion. Of the 31 patients included, 16 (52%) had an empty uterine cavity at follow up six days after inclusion, 11 (35%) required surgical evacuation for retained intrauterine products of conception found at follow up, and four (13%) required emergency surgical evacuation due to severe pain or bleeding. The results do not support the use of mifepristone and misoprostol for women wishing the miscarriage to be resolved quickly.     

A comparison of gemeprost (Cervagem) pessaries and Lamicel tents for cervical preparation for abortion by dilatation and suction

Summary. In a randomized, single-blind trial, 78 women having vaginal termination of pregnancy were treated with either a 1-mg gemeprost (Cervagem) pessary or a Lamicel tent inserted 3–4 h before operation. Both agents produced satisfactory cervical softening but dilatation was significantly easier after gemeprost. Pre-operative side-effects were more frequent after gemeprost but did not increase the need for analgesia. There were no differences between the two groups with regard to either postoperative symptoms and analgesic requirements or pre-operative and postoperative temperature, pulse rate and blood pressure. Gemeprost pessaries are easier, faster and less uncomfortable to administer.     

A comparison of gemeprost (Cervagem) pessaries and Lamicel tents for cervical preparation for abortion by dilatation and suction

In a randomized, single-blind trial, 78 women having vaginal termination of pregnancy were treated with either a 1-mg gemeprost (Cervagem) pessary or a Lamicel tent inserted 3-4 h before operation. Both agents produced satisfactory cervical softening but dilatation was significantly easier after gemeprost. Pre-operative side-effects were more frequent after gemeprost but did not increase the need for analgesia. There were no differences between the two groups with regard to either postoperative symptoms and analgesic requirements or pre-operative and postoperative temperature, pulse rate and blood pressure. Gemeprost pessaries are easier, faster and less uncomfortable to administer.     

Medical termination of early pregnancy with mifepristone (RU 486) followed by a prostaglandin analogue. Study in 16,369 women.

We report the results of a large-scale trial with mifepristone (RU 486) followed by the administration of a prostaglandin (PG) analogue for the medical termination of early pregnancy. Altogether, 16,173 patients from 300 centers were evaluated. 48 women (0.3%) were lost to follow-up prior to, and 416 (2.6%) after the PG administration, and therefore the efficacy was evaluated in 15,709 women. Overall, the success rate was 95.3%, with no statistical difference regarding the nature and dose of PG used. The median duration of bleeding was 8 days, being 12 days or less in 89.7% of the women. Bleeding was significant enough to necessitate a vacuum aspiration or a dilatation and curettage in 0.8% of the cases. A blood transfusion was necessary in 0.1% of the women (11 patients). Serious cardio-vascular side-effects were reported in 4 cases after the PG (sulprostone) injection: they consisted of one acute myocardial infarction attributed to a coronary spasm, and in marked hypotension in the other 3 women. All patients recovered uneventfully. In conclusion, RU 486 followed by a PG analogue provides an efficient and safe medical alternative to surgery for early pregnancy termination, provided that the recommended protocol is adequately followed and the contraindications to prostaglandins are respected.     

The use of 16,16-dimethyl-transδ2 prostaglandin E1 methyl ester (gemeprost) vaginal pessaries for the termination of pregnancy in the early second trimester. A comparison with extra-amniotic prostaglandin E2

Summary. The use of gemeprost pessaries has been compared in an open randomized trial with the extra-amniotic infusion of prostaglandin E₂ (PGE₂) for the termination of pregnancy between 12 and 16 weeks gestation. The success rates were 77% and 79% for the pessary and infusion group respectively, and these rates were unaffected by parity. There was no significant difference in the cumulative abortion rate between the two groups, nor were there differences in the induction-abortion interval, nor in the time taken to the onset of pain or bleeding. However, women in the pessary group required significantly less analgesia than those in the infusion group. Side-effects, experienced both during treatment and during the 6 weeks after abortion, were similar in both groups. Gemeprost vaginal pessaries are an effective alternative to the extra-amniotic infusion of PGE, for the termination of pregnancy in the early second trimester.     

Value of Schwangerschaftsprotein 1 (SP1) and pregnancy-associated plasma protein-A (PAPP-A) in the clinical management of threatened abortion

Summary. Pregnancy-associated plasma protein-A (PAPP-A) and Schwangerschaftsprotein 1 (SP₁) levels were measured in single serum samples from 60 patients admitted with vaginal bleeding in the first 14 weeks of pregnancy. When based on ultrasound diagnoses the prediction of non-viability (the predictive value) was 97% for SP₁ and 84% for PAPP-A. Whereas the prediction of viability (above –2SD of the normal range) with SP₁ was 88% the value with PAPP-A was only 57%; the poorer result obtained with PAPP-A probably reflects its longer half-life. Pregnancy outcome is not related to the duration of bleeding.     

A Comparison of Assay Methods for Pregnancy Specific β1 Glycoprotein (SP-1)

Summary: Three methods were compared for the assay of pregnancy specific β₁ glycoprotein (SP-1): radial immunodiffusion (RID), electroimmunodiffusion (EID) and radioimmunoassay (RIA). There was a significant correlation between EID and RIA. A lower, but still significant correlation was found between EID and RID, but wide discrepancies were seen in some cases. This finding suggests heterogeneity of SP-1 molecule(s). The data indicate that EID is the method of choice for assay of SP-1 after the tenth week of pregnancy, while the more sensitive RIA should be reserved for use before that stage.     

Early pregnancy termination: a comparison between vacuum aspiration and medical abortion using prostaglandin (16,16 dimethyl-trans-Delta;2-PGE, methyl ester) or the antiprogestogen RU 486

Summary. Three different regimens for termination of early pregnancy by medical means were compared to vacuum aspiration. Women seeking therapeutic abortion of pregnancy (56 days amenorrhoea) were allocated to one of four treatment groups: (1) vacuum aspiration (n = 28); (2) 1 mg vaginal pessary of a prostaglandin analogue (gemeprost) every 3 h for up to 5 pessaries ( n =30); (3) the antigestogen (RU 486 mefipristone) 150 mg per day for 4 days by mouth ( n =20); (4) RU 486 in the same dose as group 3 together with 1 mg gemeprost on day 3 (n = 19). Complete abortion occurred more often in women treated with vacuum aspiration (96%), gemeprost alone (97%) and RU 486 plus gemeprost (95%) than in those treated with RU 486 alone (60%). In women receiving up to five gemeprost pessaries alone vomiting occurred in 7 (23 %) and diarrhoea in 10 (33%); 16 (53%) required parenteral opiates for relief of pain. Side-effects and analgesic requirements were much reduced in the women who received RU 486 alone or in combination with a single gemeprost pessary. There was no difference in the number of days of vaginal bleeding after abortion between the four groups although there was wide individual variation (mean 10 days, range 1–34). These results confirm that medical induction of abortion in early pregnancy with prostaglandin vaginal pessaries is as effective as vacuum aspiration and that the dose can be reduced five-fold without loss of efficacy when used in combination with RU 486.