Gemeprost Vaginal Pessaries Research Articles

How Safe is Gemeprost? A Case Report of a Middle-aged Female Developing Acute Myocardial Infarction after Insertion of Gemeprost Vaginal Pessary and a Review of its Usage

How Safe is Gemeprost? A Case Report of a Middle-aged Female Developing Acute Myocardial Infarction after Insertion of Gemeprost Vaginal Pessary and a Review of its Usage

A randomised study of misoprostol and gemeprost in combination with mifepristone for induction of abortion in the second trimester of pregnancy

Objective To compare the effectiveness of gemeprost and misoprostol as prostaglandins used in combination with mifepristone for induction of mid-trimester termination. Design Randomised trial. Setting Scottish teaching hospital. Sample One hundred women undergoing abortion between 12 and 20 weeks. Methods Each woman received 200 mg mifepristone and 36–48 hours later either 1 mg gemeprost vaginal pessary every 6 hours for 18 hours or 4 × 200 μg misoprostol tablets vaginally followed by 2 × 200 μg misoprostol tablets orally every 3 hours for 12 hours. Success was defined as the percentage of women aborted within 24 hours of the first administration of prostaglandin. Main outcome measures Prostaglandin–abortion interval and side effects. Results There were no significant differences in median prostaglandin–abortion interval between gemeprost (6.6 hours 95% CI 6.0–10.7) and misoprostol (6.1 hours 95% CI 5.5–7.5) ( P = 0.22). The cumulative abortion rates at 24 hours (96% vs 94%, respectively), the surgical evacuation rates (12% and 10%) and the incidence of vomiting, diarrhoea and pain were similar. Conclusion Two hundred milligrammes of mifepristone followed 36–48 hours later by either vaginal gemeprost or misoprostol is a highly effective way of inducing abortion in the second trimester of pregnancy.

Termination of third-trimester pregnancy before term with gemeprost vaginal pessaries

Determination of the efficacy and side-effects of the synthetic prostaglandin analog gemeprost for termination of pregnancy in the third trimester. Retrospective record study of 40 women who had undergone third trimester termination of pregnancy before term by serial administration of gemeprost because of intrauterine fetal death or hopeless fetal prognosis. Patients with multiple pregnancy, a Bishop score > 5, contractions or contraindications to prostaglandins were excluded. Gemeprost vaginal pessaries (1-mg) were given at 6-hourly intervals until labor intervened. The main parameter studied was the induction-delivery interval, the length of time between administration of the first dose and delivery. Statistical analysis was performed with the chi-square and the Mann-Whitney U-test. The median induction-delivery interval was 14.4 h (range 3-48 h). Delivery occurred within 12 h in 17 women (42.5%), within 24 h in 27 women (67.5%) and within 36 h in 37 women (92.5%). An average of 2.6 doses were given per patient. Multigravidae had a significantly shorter induction-delivery interval than primigravidae (p < 0.01). A total of 87.5% women required analgesia. Side-effects were infrequent. The administration of gemeprost vaginal pessaries represents an efficient method with few side-effects for the induction of labor in the third trimester, provided patients are chosen carefully and monitored closely.

Medical abortion in the first trimester

Pregnancy can be terminated safely by inducing abortion medically at any stage of gestation. Antagonists such as mifepristone block the action of progesterone and hence result in uterine contractions and increase the sensitivity of the uterus to prostaglandins. In the last 15 years the combination of a single dose of mifepristone (600mg) followed 48 hours later with a suitable prostaglandin (1mg gemeprost vaginal pessary or 400μg oral misoprostol) has been licensed in most countries in Europe and the USA for induction of abortion in the early weeks of pregnancy. The safety and efficacy of these methods is comparable to vacuum aspiration at the same gestation. The complete abortion rate is related to the type and dose of prostaglandin, the route of administration as well as the gestation and parity. Published data suggest that the dose of mifepristone can be reduced from 600mg to 200mg without loss of efficacy. Although misoprostol tablets are formulated for oral use, extensive clinical experience has demonstrated vaginal administration is more effective and is associated with fewer side-effects. Successful abortion using medical methods requires a well organized service which includes referral without delay and a robust system of follow up to identify failures. The failure rate as reflected by the number of women who require surgical intervention falls with increasing experience. In those countries where medical abortion has been freely available for about 10 years, such as France, Scotland and Sweden, about 60–70% of eligible women elect for this method.

Termination of third-trimester pregnancy before term with gemeprost vaginal pessaries

Objective. Determination of the efficacy and side-effects of the synthetic prostaglandin analog gemeprost for termination of pregnancy in the third trimester. Patients. Retrospective record study of 40 women who had undergone third trimester termination of pregnancy before term by serial administration of gemeprost because of intrauterine fetal death or hopeless fetal prognosis. Patients with multiple pregnancy, a Bishop score > 5, contractions or contraindications to prostaglandins were excluded. Methods. Gemeprost vaginal pessaries (1-mg) were given at 6-hourly intervals until labor intervened. The main parameter studied was the induction-delivery interval, the length of time between administration of the first dose and delivery. Statistical analysis was performed with the chi-square and the Mann–Whitney U-test. Results. The median induction-delivery interval was 14.4 h (range 3–48 h). Delivery occurred within 12 h in 17 women (42.5%), within 24 h in 27 women (67.5%) and within 36 h in 37 women (92.5%). An average of 2.6 doses were given per patient. Multigravidae had a significantly shorter induction-delivery interval than primigravidae (p < 0.01). A total of 87.5% women required analgesia. Side-effects were infrequent. Conclusions. The administration of gemeprost vaginal pessaries represents an efficient method with few side-effects for the induction of labor in the third trimester, provided patients are chosen carefully and monitored closely.

Parity is a major determinant of success rate in medical abortion: a retrospective analysis of 3161 consecutive cases of early medical abortion treated with reduced doses of mifepristone and vaginal gemeprost

The antiprogesterone mifepristone in combination with a suitable prostaglandin provides an effective method for induction of abortion in early pregnancy up to 63 days of gestation. The combination of 600 mg mifepristone followed by 1 mg of gemeprost vaginal pessary 48 h later is one of the standard regimens in practice, which is registered in several countries in Europe. In 1995, we reduced the doses for both mifepristone and gemeprost to 200 mg and 0.5 mg respectively, as this was shown to decrease significantly the incidence of side effects whilst maintaining a high efficacy. In this article, we report our experience with this regimen in routine clinical practice by analysing 3161 consecutive medical abortions retrospectively. Twelve case notes (0.4%) were not available, and for 310 (9.8%) women, the outcome was not known with certainty as they did not return for their follow up visit. Of the remaining 2839 women, 2732 (96.2%) had a complete abortion following their treatment. One-hundred-two (3.6%) women required an evacuation of the uterus: for incomplete abortion in 63 (2.2%) and ongoing pregnancy in 39 (1.4%). Three women had to undergo surgery for ectopic pregnancies. The surgical intervention rate was significantly higher at gestation of >49 days compared to ≤49 days (5.7% vs. 2.6%, p = 0.002) and at >56 days than among those at ≤56 days (6.7% vs. 3.1%; p <0.001). However, for incomplete abortion a significant increase was only seen at gestation >49 days compared to ≤49 days (3% vs. 1.6%, p = 0.017). The incidence of ongoing pregnancies increased significantly only after 56 days of gestation compared to ≤56 days (3.8% vs. 0.9%; p <0.001). Parity was related to the outcome with parous women having significantly more incomplete/ongoing abortions compared to nulliparous women (5.4% vs. 2.0%; p <0.001), although parous women did present earlier in pregnancy for termination than nulliparous women ( p = 0.01). The incidence of complications was low: 165 (5.8%) women were given antibiotics for presumed genital infection and severe haemorrhage occurred in 11 (0.4%) women, of whom only two required blood transfusion. In summary, the recommended regimen with the reduced doses of mifepristone and gemeprost is highly effective, meeting the anticipated efficacy with a complete abortion rate of >95%. We have concluded from the data that gestation and parity are strong predictors for clinicians to anticipate the probability of a successful medical termination of pregnancy.

Termination of pregnancy in the 2nd trimester by serial administration of gemeprost vaginal suppositories. A prospective study (corrected)

In a prospective study termination of pregnancy was performed between the 16th and 24th week of gestation by serial applications of a 1 mg gemeprost containing vaginal pessary at 6h intervals. The reasons for termination were medical and fetal indications in 20 cases and missed abortion in 14 cases. The median induction to abortion interval was 17.4 hours (range: 3.7 - 73.0h) in the therapeutic abortion group, and a median of 3 applications were necessary to terminate pregnancy. In cases of missed abortion the median induction to abortion intervals was 11.0h (range: 3.5 - 32.5h) with a median of 2 necessary applications. Expulsion of the fetus occurred in 31 out of 34 patients (91.2%) within 24 hours. Spontaneous or surgically induced cervical lesions and blood loss > 500 ml were not observed, systemic prostaglandin-induced side effects were documented in 7 cases (20.6%). Epidural anesthetic gave a painless induction of abortion in all of patients. Our experience has shown that serial application of gemeprost vaginal pessaries is a feasible and efficient method for termination of second trimester pregnancies.

Pregnacny: The abortifacient effect of misoprostol in the second trimester. A randomized comparison with gemeprost in patients pre-treated with mifepristone (RU486)

The objective of this work was to study the abortifacient effects of misoprostol, an orally active prostaglandin E1 (PGE1) analogue, in the second trimester. A randomized study of two prostaglandin regimens in women pre-treated with the antiprogesterone mifepristone was carried out in the gynaecological wards of Aberdeen Royal Hospitals, NHS Trust, and included 60 women at 13-20 weeks' gestation, in whom termination of pregnancy had been agreed. Following pre-treatment with mifepristone 600 mg women were randomly allocated to one of two prostaglandin regimens which started 36-48 h later. The first misoprostol 400 micrograms orally (up to three doses) followed by gemeprost vaginal pessary 1 mg up to two doses. The second was gemeprost vaginal pessary 1 mg up to five doses. The main outcome measures were success rate induction-to-abortion interval and side-effects. There were no significant differences between the two groups in any of the main outcome measures. We conclude that misoprostol is a stable, cheap PGE1 analogue with demonstrable efficacy and acceptable side-effects in the management of second trimester abortion. Further work is needed to establish the optimum dose and regimen.

A study of gemeprost alone, dilapan or mifepristone in combination with gemeprost for the termination of second trimester pregnancy

It is well established that abortion can be induced successfully in midtrimester of pregnancy by gemeprost vaginal pessaries. A randomised study was carried out to determine the efficacy of mifepristone and dilapan in combination with gemeprost for second trimester termination between 12–18 weeks' gestation. A contemporary group of women treated with gemeprost alone was used as a control group. A single course of 4 × 1 mg gemeprost pessaries was administered every six hours. If abortion had not occurred after 24 hours, a further course of 5 × 1 mg pessaries was administered every three hours over the next 24 hours. In the first twenty hours after administration of gemeprost, 95%, 85% and 72% of women aborted in the mifepristone, dilapan and the control group, respectively. The median induction-abortion interval in the mifepristone group (6.6h) was significantly shorter than the other two groups and fewer pessaries were required to induce abortion. The incidence of diarrhoea and vomiting was lower in the mifepristone than the other two study groups. This study demonstrated the efficacy of mifepristone in combination with gemeprost and this regimen is associated with fewer gastrointestinal side effects.

Multiple fetal anomalies in the first trimester; detection using transvaginal ultrasound and therapeutic abortion using mifepristone (RU486) in conjunction with gemeprost vaginal pessaries

Multiple fetal anomalies in the first trimester; detection using transvaginal ultrasound and therapeutic abortion using mifepristone (RU486) in conjunction with gemeprost vaginal pessaries

Medical abortion and the availability of RU486 -- are women's rights being ignored in developing countries?

40 of the 500000 women dying of pregnancy related causes are a result of unsafely performed abortions. The development of RU486 has the potential in developing countries of being the most significant advance in reproductive medicine. The need is great for the developing world to have access and it is unfortunate deny women access to safe abortion. The author identifies how RU486 works the advantages and disadvantages of medical abortion in developing countries comparative research evaluation problems obstacles to availability (religious opposition legal barriers monopoly and patent concerns cost) and the role of the WHO. RU486 or mifepristone or Mifegyne acts by provoking bleeding in the endometrium and thus rejection of the embryo. A single oral 600 mg dose followed up 36-48 hours later with a synthetic prostaglandin analogue (gemeprost vaginal pessary) has been found to be effective in inducing abortion in 95% of cases that are within 56 days of the last menses. 4% require surgical evacuation. 1% continue. Bleeding begins within 48 hours and becomes heavier with pain. 8 hours after administration of the prostaglandin is the usual period of fetal elimination. 25% of abortions performed in France utilize this method. The advantage for developing countries is the independence from the skills of the practitioner and the medical surroundings or equipment. It is noninvasive and does not have the risk of infection that surgical abortion has. Skilled personnel are in short supply in developing countries. Because it is a method for early abortion it can be used in Muslim countries. Risk assessment is being conducted in clinical trials in rural China. A disadvantage is improper administration without medical supervision such as in late administration or without the prostaglandin. Advantages vary by country. In those countries where abortion mortality is high the advantage would be greater. Anti abortion groups in the US and Muslim and Catholic groups in Britain are being asked to boycott Roussel Uclaf drugs because of the manufacture of RU486. The US has also withdrawn international funding for abortion. Where abortion is illegal legal product licenses are not possible. Menstrual regulation and early surgical abortion are legal in some countries however. Legal importation of RU486 for other medical uses is possible. Monopoly nondistribution may be circumvented by licensing the product of WHO although still vulnerable to US government anti abortionists.

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

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. A randomized, operator blind, placebo controlled trial. UK teaching hospital. 90 primigravid women with 63-91 days amenorrhoea and ultrasonically confirmed single living fetus of correct size for gestational age. 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. Onset of new symptoms following drug administration, a proven objective measure of the force required to dilate the cervix, and estimated intraoperative blood loss. 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. Mifepristone is a highly effective cervical priming agent, and has the advantages of being an oral preparation associated with few side effects.

Uterine rupture in midtrimester abortion. A complication of gemeprost vaginal pessaries and oxytocin. Case report

The 1st reported case of uterine rupture in pregnancy termination associated with the administration of gemeprost and oxytocin involved a 24-year-old UK women with 3 previous uncomplicated pregnancies. Pregnancy termination, performed at 16 weeks of gestation, involved the insertion of 1 mg gemeprost vaginal pessaries into the posterior fornix at 3-hour intervals. A total dose of 5 mg of gemeprost was administered in the 1st 24 hours. Another treatment course was instituted the following day, and the patient's cervix remained closed despite the onset of contractions and slight vaginal bleeding. During the 2nd course of 5 pessaries, the patient also received 4 15 mg doses of intramuscular papaveretum. On the 3rd day, a intrauterine pregnancy was visible on ultrasound scan, but no fetal heartbeat was detected. A total dose of 50 IU of oxytocin was then administered over a 22-hour period. The diagnosis of uterine rupture was made on day 4 when vaginal examination revealed a large bulging lower uterine segment anteriorly and a closed cervix posteriorly. The patient's hemoglobin concentration had fallen from an admission value of 11.4 g/dl to 6.5 g/dl. Laparotomy revealed a large left broad ligament hematoma extending anteriorly into which the fetus had been extruded. Total abdominal hysterectomy was required. The uterine rupture is assumed to have occurred during the 2nd course of gemeprost. The absence of previously reported cases of gemeprost-associated uterine rupture may reflect the rarity of this method of pregnancy termination in the 2nd trimester.

Gynaecological short communication Second trimester abortion with vaginal gemeprost or intravenous sulprostone

SummaryOne hundred and three women received either gemeprost vaginal pessaries, 1 mg 3-hourly up to 5 mg; or two 3 mg prostaglandin E2 vaginal tablets, 12 and 6 hours respectively before an intravenous infusion of sulprostone (1500 μg), for second trimester abortion. The 24 h abortion rate with gemeprost was 79 per cent (42/53), compared to 62 per cent (31/50) in the sulprostone patients (P<0.05). Uterine pain occurred in both groups; there was vomiting in 32 and 16 per cent, and diarrhoea in 11 and 2 per cent, respectively, in the gemeprost and sulprostone patients.

Uterine rupture in midtrimester abortion. A complication of gemeprost vaginal pessaries and oxytocin. Case report.

Uterine rupture in midtrimester abortion. A complication of gemeprost vaginal pessaries and oxytocin. Case report.

Late second trimester abortion with 16,16-dimethyl-trans-δ 2-PGE1 methyl ester (gemeprost)

The use of gemeprost (16, 16-dimethyl-trans- Δ 2-PGE1 methyl ester) vaginal pessaries for the termination of pregnancy in the late second trimester has been investigated in an open single-center study. Of 56 nulliparous women between 18 and 22 weeks amenorrhoea, 33 (58.9%) aborted after the administration of 1 mg gemeprost pessaries; 5 women did abort after 3 doses, 10 after 4 doses and 18 after 5 doses. There was no statistical correlation between gestational age and abortion. The mean induction-abortion interval was 15.2 hrs (range 8.5–20.3 hrs). There were no serious complications. The safe induction of therapeutic abortion in 58.9% of women using vaginal gemeprost pessaries alone offers an acceptable alternative to surgical evacuation in the late second trimester but should not be started without the possibility to terminate the procedure by dilatation and evacuation ( D + E).

Gemeprost vaginal pessaries for inducing third‐trimester intrauterine deaths

Gemeprost vaginal pessaries for inducing third‐trimester intrauterine deaths

The Experience of Termination of Second Trimester Pregnancies Using Gemeprost Vaginal Pessaries in a District General Hospital

Experience with the use of Gemeprost pessaries (prostaglandin E1 analogue), in a group of 60 consecutive patients for second trimester termination in a Scottish District General Hospital, is presented. Gestation ranged from 12 to 20 weeks; there were 29 nulliparous (48%) and 31 (52%) multiparous women. Fifty-seven (95%) aborted within 36 hours; 29 (48%) aborted completely and did not require further uterine curettage. Nulliparous patients required more pessaries and the abortion was more often incomplete. Side effects were minimal. There were no serious problems; and antiemetics were required by 17% and parenteral analgesics by 13% of patients.

Blood loss following induction of early abortion using mifepristone (RU 486) and a prostaglandin analogue (gemeprost)

The pattern and amount of blood loss following induction of therapeutic abortion using mifepristone (RU 486) and a prostaglandin E analogue (gemeprost) was studied in 222 women of less than 63 days amenorrhoea. A single oral dose of mifepristone (400, 500 or 600 mg) was followed 48 hours later by a half or 1 mg gemeprost vaginal pessary. Complete abortion occurred in 218 (98%) women without necessity for surgical evacuation of the uterus. Bleeding commonly occurred following administration of mifepristone and prior to prostaglandin administration. The median duration of bleeding following abortion was 13 days with a range of from 1 to 44 days. There was a wide individual variation in measured blood loss between women, from 14 to 512 ml, with a median loss of 74 ml. The amount of blood loss was independent of the dose of mifepristone or prostaglandin but was significantly correlated with gestation. These results confirm that the combination of mifepristone and gemeprost is a highly effective and safe method of inducing therapeutic abortion medically. As the amount of blood loss increases with increasing gestation, it is suggested that its use should be restricted to women with amenorrhoea ≤ 56 days.

Gemeprost vaginal pessaries for inducing third-trimester intrauterine deaths.

In 3rd trimester fetal death, when the cervix requires softening, labor may be induced by the administration of intravenous, intra-or extraamniotic, or vaginal prostaglandin E2 or intramuscular injections of synthetic prostaglandins, such as 15(S)-methyl prostaglandin F2 alpha. These methods all have various disadvantages. In 10 women with 3rd trimester intrauterine death, labor was induced by vaginal insertion of a 1 mg gemeprost (16,16-dimethyl-trans delta 2 prostaglandin E1 methyl ester) pessary. The mean number of pessaries s required was 1.9, and the mean duration of labor was 11.7 hours. The women remained mobile during most of the procedure. No patient required additional oxytocin, and the only side effects were mild fever and diarrhea.