gemeprost and sulprostone

Preparing the cervix prior to surgical abortion is intended to make the procedure both easier and safer. Options for cervical preparation include osmotic dilators and pharmacologic agents. Many formulations and regimens are available, and recommendations from professional organizations vary for the use of preparatory techniques in women of different ages, parity or gestational age of the pregnancy.. To determine whether cervical preparation is necessary in the first trimester, and if so, which preparatory agent is preferred.. We searched Cochrane, Popline, Embase, Medline and Lilacs databases for randomised controlled trials investigating the use of cervical preparatory techniques prior to first trimester surgical abortion. In addition, we hand-searched key references and contacted authors to locate unpublished studies or studies not identified in the database searches.. Randomised controlled trials investigating any pharmacologic or mechanical method of cervical preparation, with the exception of nitric oxide donors (the subject of another Cochrane review), administered prior to first trimester surgical abortion were included. Outcome measures must have included the amount of cervical dilation achieved, the procedure duration or difficulty, side-effects, patient satisfaction or adverse events to be included in this review.. Trials under consideration were evaluated by considering whether inclusion criteria were met as well as methodologic quality. Fifty-one studies were included, resulting in 24 different cervical preparation comparisons. Results are reported as odds ratios (OR) for dichotomous outcomes and weighted mean differences for continuous data.. When compared to placebo, misoprostol (400-600 microg given vaginally or sublingually), gemeprost, mifepristone (200 or 600 mg), prostaglandin E and F(2alpha) (2.5 mg administered intracervically) demonstrated larger cervical preparation effects. When misoprostol was compared to gemeprost, misoprostol was more effective in preparing the cervix and was associated with fewer gastrointestinal side-effects. For vaginal administration, administration 2 hours prior was less effective than administration 3 hours prior to the abortion. Compared to oral misoprostol administration, the vaginal route was associated with significantly greater initial cervical dilation and lower rates of side-effects; however, sublingual administration 2-3 hours prior to the procedure demonstrated cervical effects superior to vaginal administration.When misoprostol (600 microg oral or 800 microg vaginal) was compared to mifepristone (200 mg administered 24 hours prior to procedure), misoprostol had inferior cervical preparatory effects. Compared to day-prior laminaria tents, 200 or 400 microg vaginal misoprostol showed no differences in the need for further mechanical dilation or length of the procedure; similarly, the osmotic dilators Lamicel and Dilapan showed no differences in cervical ripening when compared to gemeprost, although gemeprost had cervical effects which were superior to laminaria tents. Older prostaglandin regimens (sulprostone, prostaglandin E(2) andF(2alpha)) were associated with high rates of gastrointestinal side-effects and unplanned pregnancy expulsions. Few studies reported women's satisfaction with cervical preparatory techniques.. Modern methods of cervical ripening are generally safe, although efficacy and side-effects between methods vary. Reports of adverse events such as cervical laceration or uterine perforation are uncommon overall in this body of evidence and no published study has investigated whether cervical preparation impacts these rare outcomes. Cervical preparation decreases the length of the abortion procedure; this may become increasingly important with increasing gestational age, as mechanical dilation at later gestational ages takes longer and becomes more difficult. These data do not suggest a gestational age where the benefits of cervical dilation outweigh the side-effects, including pain, that women experience with cervical ripening procedures or the prolongation of the time interval before procedure completion. Mifepristone 200 mg, osmotic dilators and misoprostol, 400microg administered either vaginally or sublingually, are the most effective methods of cervical preparation.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Alprostadil; Cervical Ripening; Dinoprost; Dinoprostone; Female; Humans; Mifepristone; Misoprostol; Pregnancy; Pregnancy Trimester, First

Induction of labour is a common obstetric instrument to employ when the potential risk to continue a pregnancy is higher than to terminate it. The methods of induction can be pharmacological or mechanical; the choice of the method mainly depends by the cervical ripening, as it is significantly able to influence, according to the type of induction, its final issue. The mechanical methods are: stripping and sweeping of the membranes, hand dilatation of cervix, intrauterine pressure catheters, Laminaria Japonicum, transcervical Foley catheter and amniotomy. To pharmacological methods include some agents such as the prostaglandins (PG), the most common approach to induce a labour, and used above all by vaginal way in patients with unripe cervix. They simulate the natural PG effects at the beginning of delivery and show a great efficiency. There are a lot of PG on the market, but except some of them, as Dinoprostone for PGE2 and Misoprostol for PGE1, no one of them shows the same safety in management of labour. Oxytocin, another inductive method, administered by diluted intravenous infusion, is utilized alone or mainly with other methods when the labour is started or with rupture of the membranes, because it begins or maintains the myometrial contraction.

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Adrenal Cortex Hormones; Alprostadil; Catheterization; Dinoprostone; Estrogens; Female; Humans; Interleukin-8; Labor, Induced; Mifepristone; Oxytocin; Pregnancy; Prostaglandins; Relaxin

Antiprogestin alone is not sufficiently effective in terminating early pregnancy to be clinically useful. The only exception seems to be immediate post-ovulatory administration which inhibits endometrial development to an extent that prevents implantation of the fertilized ovum. During early pregnancy the uterus is inactive. Treatment with antiprogestin with result in an increased uterine contractility and a significant increase of myometrial sensitivity to prostaglandin. The effect is probably mainly due to the release of the inhibitory effect of progesterone. Antiprogestin not only activates the uterus, it also causes a ripening of the cervix. The combination of RU486 and either vaginal administration of gemeprost or i.m. injections of nalador provide a safe and effective medical abortion in the first 8 weeks of pregnancy. Recent clinical studies indicate that it may be possible to replace the prostaglandin analogues in current use by the orally active analogue misoprostol. Misoprostol is inexpensive and stable at room temperature and would facilitate the provision of medical abortion with mifepristone. Experimental data also indicate that a combination of RU486 and misoprostol may be developed into an effective once-a-month late luteal method to regulate fertility. Pre-treatment with RU486 is also useful in later stages of gestation. A combination of RU486 and the vaginal administration of gemeprost is a highly effective, safe and simple non-invasive method for terminating both early and late second trimester pregnancy.

Topics: Abortifacient Agents, Steroidal; Abortion, Induced; Alprostadil; Cervix Uteri; Clinical Trials as Topic; Dinoprostone; Drug Synergism; Female; Humans; Laminaria; Mifepristone; Misoprostol; Multicenter Studies as Topic; Myometrium; Pregnancy; Pregnancy Trimester, First; Pregnancy Trimester, Second; Progesterone; Randomized Controlled Trials as Topic; Uterine Contraction

Topics: Abortifacient Agents, Nonsteroidal; Alprostadil; Delivery, Obstetric; Dinoprostone; Female; Fetal Death; Humans; Pessaries; Pregnancy; Time Factors

This article outlines the current modalities of pregnancy termination, as well as their risks and complications, in 3 phases of pregnancy: 1) up to 49 days past the last menstrual period, 2) 8-15 weeks, and 3) 16-24 weeks. Before 8 weeks of pregnancy, suction dilatation and curettage (D and C) is the preferred method. However, a medical approach, possibly self-administered, is viewed as more satisfactory and requires only an improvement in side effects. From 8-15 weeks' gestation, suction D and C and dilatation and evacuation (D and E) are the methods of choice. The use of laminaria tents improves both the facility and safety of these procedures in nulliparous patients and perhaps in multiparous patients. Priming of the cervix with prostaglandin could further decrease the difficulty and risks of these procedures. The use of a hydrogel compound is especially worthy of consideration. There is controversy about the preferred method between 16-20 weeks' gestation. D and E appears to have fewer complications and to be more cost-effective than hypertonic saline injection. Urea-prostaglandin has fewer and less severe complications than saline injection, and seems to be more cost-effective than saline injection in terms of duration of hospitalization. The high frequency of failure and side effects, combined with the possibility of expulsion of a live fetus, make prostaglandin-only injection less desirable. After 20 weeks' gestation, urea-prostaglandin injection is probably the safer method. Given the rapid increase in complications with passing weeks, any delay in providing late abortion services should be avoided. 2nd trimester pregnancy terminations, especially those after 18 weeks' gestation, are associated with increased mortality and morbidity and should be performed at specialized centers where providers are better equipped to manage complications.

Topics: 16,16-Dimethylprostaglandin E2; Abortifacient Agents; Abortion, Induced; Alprostadil; Amnion; Anesthesia; Animals; Arbaprostil; Bacterial Infections; Carboprost; Cervix Uteri; Dilatation and Curettage; Dinoprost; Dinoprostone; Female; Humans; Hypertonic Solutions; Oxytocin; Pregnancy; Pregnancy Trimester, First; Pregnancy Trimester, Second; Progestins; Prostaglandins E; Prostaglandins E, Synthetic; Prostaglandins F; Pulmonary Embolism; Risk; Saline Solution, Hypertonic; Time Factors; Urea; Uterine Hemorrhage; Uterine Perforation

In a randomized, prospective study at the Dept. of Obstetrics and Gynecology of the University Hospital of Giessen 4 different ways of inducing abortions with prostaglandins were tested between the 15th and 24th week of gestation. The aim of the study was to determine the best approach to inducing abortion in order to minimize the psychological and physical stress to the patient. Subjects randomized to the first two groups got a single cervical installation of either 0.5 mg Dinoprostongel (Prepidil, N = 22) or 0.5 mg Sulprostongel (Nalador, N = 21). Six hours later, i.v. infusion with Sulproston (8.3 micrograms/min) was started and continued until the abortion was complete. Patients randomized to the third and fourth group received either 0.5 mg Dinoprostongel intracervically (N = 15) or 1 mg Gemeprost vaginal suppositories (Cergem, N = 21) every 6 hours until the cervix was 1-2 cm dilated. Subsequently the patients received an i.v. infusion with Sulproston until the abortion was complete. In the first group with intracervical application of Sulproston the total time until abortion was 17.8 h +/- 7.8 h. This was shorter than following a single application of Dinoprostongel (22.5 h +/- 14.7 h). Although there was a five hours difference, the between-group differences were not statistically different because of a wide range in values following Dinoproston treatment. This range could not be explained by the age of the mother, week of gestation or parity. In the group receiving multiple intracervical applications of Dinoproston the time till expulsion was twice as long as that after multiple vaginal suppositories of Gemeprost (33.8 h +/- 13.9 h vs. 15.6 +/- 6.0 h, p < 0.01). The time span until a cervical dilatation of 1-2 cm was 27.0 h +/- 13.7 h in the group with repeated Dinoproston application. This period of time was more than twice the time span seen in the group with repeated Gemeprost application (12.5 h +/- 4.2 h, p < 0.01). On the average four treatments with intracervical Dinoprostongel were required while the average with Gemeprost vaginal suppositories was two to achieve a cervical dilatation of 1-2 cm. Furthermore in 7 of 21 cases treatment with Gemeprost achieved the expulsion of the fetus without Sulproston infusion (11.4 h +/- 5.2 h). Comparing single versus repetitive prostaglandin application we could demonstrate that the duration of Sulproston infusion was cut in half after repeated therapy with Gemeprost. We conclude that repetitive appli

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Eugenic; Abortion, Induced; Administration, Intravaginal; Adult; Alprostadil; Dinoprostone; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infusions, Intravenous; Pregnancy; Pregnancy Trimester, Second; Prospective Studies; Time Factors; Treatment Outcome

RU486 (mifepristone) followed by a prostaglandin (PG) analogue has been marketed in France since April 1990 as a medical alternative to surgery for early pregnancy termination. By law, the drug is used only in the centres approved for voluntary pregnancy termination, and its distribution is strictly controlled. Before being marketed, it was distributed to more than 20,000 women, as part of a training programme for the prescribers. Analysis confirmed an efficacy rate of 95.3%. Failures included incomplete ovular expulsion (2.8%), premature vacuum aspiration (0.7%) and ongoing pregnancy (1.2%). Pelvic pain and malaise were reported as side-effects in 1.6 and 1.2% of the cases respectively. Infectious complications were reported in 0.2% of the cases. Three severe adverse events (one of which was fatal) occurred, including myocardial infarction and ventricular arhythmia, in the hours following PG administration and justify a careful medical monitoring in the centre 3-4 h after administration of PG. For this reason, a trial was undertaken to evaluate the efficacy of an oral form of a PGE1 analogue (misoprostol). When RU486 was followed 36-48 h later by 400 micrograms of misoprostol, the efficacy rate was 96.9%, indicating an efficacy equivalent to that obtained with the other PG analogues. The distribution procedures were adequately followed by the prescribers and by the patients. In summary, RU486 constitutes a safe and efficient medical means of pregnancy termination, provided that the manufacturer's recommendations are properly followed.

Topics: Abdominal Pain; Abortion, Induced; Adult; Alprostadil; Contraindications; Dinoprostone; Female; France; Humans; Hypotension; Mifepristone; Misoprostol; Myocardial Infarction; Pilot Projects; Pregnancy; Uterine Hemorrhage

In a prospective, randomised study, 40 primi- and plurigravida were treated either intracervically with 50 micrograms Sulprostone gel or vaginally with a pessary containing 1 mg Gemeprost in order to soften the cervix prior to first trimester termination of pregnancy. Curettage was performed on average 6.0 and 3.2 hours, respectively, after prostaglandin administration. For objective demonstration of the priming effect, the force required for dilatation of the cervical canal was measured in Newton by a special tonometer before prostaglandin treatment and before operation. The free passability of the cervical canal, the maximal dilatability with a force of 10 N and the increase in dilatability after local prostaglandin application were measured. A modified visual analogue scale was used to evaluate the subjective pain experience. During the time between administration and curettage, no abortion occurred in any of the patients. There were no statistically significant differences between both groups regarding the free passability and the maximal dilatability, however, the increase in dilatability was significantly greater in the Gemeprost group. The visual analogue scale allows the patient to quantify, at least to some extent, her experience of pain, but there were no differences in the rate of uterine cramps between both groups; gastrointestinal symptoms did not occur. Both methods were found to be equally efficient; the advantages of Gemeprost are the ease of administration and the short application-curettage interval; however, the cost for one Gemeprost application is nearly 6-fold higher than that of one Sulprostone gel application.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Administration, Intravaginal; Adult; Alprostadil; Cervix Uteri; Dilatation and Curettage; Dinoprostone; Dose-Response Relationship, Drug; Female; Gels; Humans; Pregnancy; Pregnancy Trimester, First; Prospective Studies; Suppositories

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.. Between May 1988 and September 1989, physicians administered 600 mg of RU-486 followed by either 1 mg gemeprost vaginal pessary or im injection of 0.125-1.0 mg sulprostone to 16,369 11-48 year old women attending 30 centers in France to evaluate this regimen's safety and efficacy and whether trained prescribers could adequately comply with recommended protocol. 13.6% patients whose gestational age was greater than the recommended 50 days, underwent RU-486 and prostaglandin (PG) analogue administration. 78% of 571 patients did not receive a PG analogue because they expelled the conceptus after RU-486 administration. The remaining 126 women did not receive RU-486 even though they had not expelled the conceptus. Clinicians administered to PG analogue to 88.4% of all women within the recommended 36-48 hours after RU-486 administration. The RU-486 and PG analogue regimen had a success rate of 95.3%. Women who received the PG analogue within the recommended time period had a higher success rate than those who received it either too early or too late (95.8% vs. 92.8% and 93.9%, respectively; p = .001). In those women who did not receive the PG analogue, RU-486's success rate was considerably lower (88.6%; p .001). The nature and does of the PG analogue greatly influenced expulsion within 4 hours after its administration (44.1% after 1 mg gemeprost vs. 57.3%, 55.8%, 73.5%, and 67.6% after 0.125, 0.25, 0.375, and 0.5 mg sulprostone respectively; p .001). The higher doses of sulprostone had a significant effect on duration of bleeding (e.g., 9.1 days for 0.5 mg vs. 7.1 days for 0.125 mg p .001). 89.7% of the women bled for no more than 12 days. The bleeding was so profuse in 0.8% of the cases that either vacuum aspiration or dilatation and curettage was needed. 11 women required 1-3 units of blood. 8.5% experienced at least 1 side effect, the most common being uterine cramps (1.6% of all cases). 4 women suffered from grave cardiovascular effects (myocardial infarction in 1 case, severe hypotension in 3 cases). As long as prescribers consider contraindications and follow the protocol, this regimen is a viable alternative to surgical abortion.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Adult; Alprostadil; Dinoprostone; Drug Evaluation; Female; France; Humans; Mifepristone; Pregnancy; Prostaglandins E, Synthetic

We made a prospective study using vaginal suppository of Géméprost (analogue of PGE1) and intravenous infusion of Sulprostone (analogue of PGE2) in thirty second- and third-trimesters pregnancy terminations. The efficacy was excellent for both procedures: only one failure, mean duration of abortion of 15 h 15 with Sulprostone, interval of 17 hours with Géméprost. In this case, the delay was shorter when vaginal administration was made every 6 hours. The evacuation of the uterus was very good, however one aspiration was made three days after abortion. Few side effects were observed with these two drugs: one case of fever, one case of vomiting, both with Sulprostone: two cases of nausea, one case of diarrhoea with Géméprost. We think that the effectiveness is marked and comparable, allowing the use of epidural anesthesia.

Topics: Abortifacient Agents; Abortifacient Agents, Nonsteroidal; Administration, Intravaginal; Adult; Alprostadil; Clinical Trials as Topic; Dinoprostone; Female; Fever; Gastrointestinal Diseases; Humans; Infusions, Intravenous; Pregnancy; Prospective Studies

This paper reviews much of the clinical data obtained with the antiprogestin RU 486 (mifepristone) in the fields of obstetrics and gynecology. To interrupt early pregnancy (less than 50 days of amenorrhea) RU 486 as a single dose of 600 mg followed 36-48 hours later by a prostaglandin derivative, constitutes an alternative to vacuum aspiration or dilatation and curettage (D and C). All three methods have comparable efficacy, provided that they are performed in centers with adequate medical facilities. RU 486 is the first antiprogestational steroid available for clinical purposes. Its pharmacological properties have been reviewed in detail elsewhere (1,2). The present paper reviews the main clinical data obtained during trials monitored by Roussel Uclaf.

Topics: 16,16-Dimethylprostaglandin E2; Abortifacient Agents, Nonsteroidal; Abortion, Induced; Alprostadil; Clinical Trials as Topic; Dinoprostone; Female; Humans; Labor, Induced; Mifepristone; Pregnancy; Pregnancy Trimester, Second

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.

Topics: 16,16-Dimethylprostaglandin E2; Abortifacient Agents; Adolescent; Adult; Alprostadil; Carboprost; Clinical Trials as Topic; Dilatation and Curettage; Dinoprostone; Female; Humans; Laminaria; Prostaglandins; Prostaglandins E, Synthetic; Random Allocation; Seaweed; Vacuum Curettage

This study reports the results obtained in the medical introduction of abortion during the second trimester of pregnancy in 52 patients following intrauterine fetal death or the diagnosis of fetal malformations.. The protocol consisted of the alternate use of intravaginal suppositories of gemeprost and intramuscular injections of sulprostone. The results were analysed using statistical methods and evaluated in relation to the different parameters present (intrauterine fetal death or therapeutic abortion, maternal age, gestation period and parity).. It was seen that the time required to induce abortive labour was significantly shorter in patients with IFD compared to patients with live fetus. The comparison between patients with a gestation period < or > 18 weeks revealed shorter induction times in the former group without reaching statistical significance.. Maternal age (under and over 30) and parity (P = 0 and P > or = 1) did not influence the results obtained.

Topics: Abortifacient Agents; Abortion, Therapeutic; Adult; Alprostadil; Dinoprostone; Female; Fetal Death; Fetus; Gestational Age; Humans; Injections, Intramuscular; Parity; Pregnancy; Pregnancy Trimester, Second; Suppositories

Comparison of 1 mg Gemeprost-Vaginal Suppositories Serial Application versus Sulproston i.v.: Three different regimens for the termination of second and third trimester pregnancies by the use of prostaglandins (PG) were compared in a retrospective analysis. In group A (n = 16) terminations were attempted by continuous i.v. Infusion of Sulproston 9 hours after administration of a 3 mg-PGE2-vaginal tablet overnight. In group B (n = 22), i.v. Sulproston was started 2 hours after priming with 1 mg Gemeprost-vaginal suppositories. The outcome of these two regimens was compared with that of repeated administration of 1 mg Gemeprost-vaginal suppositories at 6-hourly intervals (group C, n = 25). In each group. If uterine contractions failed to appear after one day, the treatment was discontinued for a sleep rest over night and then resumed. Genetic disorders or fetal malformations were the most frequent reasons for termination. Patients with intrauterine fetal demise, rupture of the membranes, preterm labour or a ripe cervix (Bishop Score > 3) were excluded. Median time intervals from induction to abortion were 33 hours in group A and 23 hours in each Group B and C. The rate of fetal expulsions within 12, 24 and 36 hours in groups B and C were similar. Women of parity > or = 1 showed significantly shorter intervals than nulliparae in groups A and C. Only one woman (in group A) failed to expel after induction, in four other cases (in groups A and B) complications (local thrombophlebitis, bronchospasm) were noted. The serial administration of 1 mg Gemeprost-vaginal suppositories at 5-hourly intervals showed fewer side effects and seems to be as efficient as sulproston i.v. after cervical ripening.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Eugenic; Abortion, Induced; Administration, Intravaginal; Adolescent; Adult; Alprostadil; Dinoprostone; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Infusions, Intravenous; Pregnancy; Pregnancy Trimester, Second; Pregnancy Trimester, Third; Retrospective Studies

The results of the cervical priming with a Dinoprost-containing gel and a Gemeprost-containing vaginal suppository were compared in 68 patients, who required termination of pregnancy beyond 14 weeks because of a severe maternal disease or a fetal abnormality. The priming consisted of either an intracervical application of Dinoprost (500 micrograms) in a tylose-gel in 6-8 hour intervals or a retrocervical application of Gemeprost (1 mg) as a vaginal suppository in 12 hour intervals. Although no significant parameter variances were found in the selected patient groups, abortion was induced in 75% of cases within 24 hours, in 89% within 36 hours using Gemeprost. Mean induction time for Gemeprost was 19.5 hours. Using Dinoprost only 19% of patients had an abortion within 24 hours (44% within 36 hours, respectively), mean induction time was significantly longer (38.8 hours, p < 0.005). These differences remained unchanged, when patients who had a prior caesarean section were not evaluated. Using Gemeprost the additional systemic administration of Sulprost was necessary in 21% of cases, using Dinoprost, in 50% of cases. Severe complications did not occur and minor side effects such as nausea or vomiting were observed in single cases. These results demonstrate that Gemeprost can be used in cervical priming even after 14 weeks of pregnancy and that the longer application interval of 12 hours results in a reduction of side effects without a decrease in efficacy.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Eugenic; Abortion, Induced; Alprostadil; Cervix Uteri; Dinoprostone; Drug Therapy, Combination; Female; Fetal Death; Gels; Humans; Parity; Pregnancy; Pregnancy Trimester, Second; Pregnancy Trimester, Third; Suppositories

Because progesterone is essential for the establishment and maintenance of pregnancy, it has long been recognized that a substance which antagonized the action of progesterone would have potential as an antifertility agent. Within 2 years of the synthesis of the progesterone antagonist RU 486 (mifepristone) it was demonstrated that bleeding and uterine contractions occurred following its administration in non-pregnant and pregnant women. Extensive trials over the last 10 years have established that a single dose of mifepristone followed 36-48 hours later by a prostaglandin, is an effective, safe alternative to vacuum aspiration for the termination of early pregnancy. Although this combination is licensed in France, China and the United Kingdom for induction of abortion, research is continuing to determine the minimum effective dose of mifepristone and type of prostaglandin which is associated with minimum side effects without loss of efficacy. In addition, studies to determine the acceptability of this type of medical abortion to women in different cultures and societies are required. The facilities necessary for medical termination differ from those for surgical abortion, although the requirements for access to emergency resuscitation and treatment of (rare) complications are similar for the two methods. Mifepristone is very effective in the management of prostaglandin-induced midtrimester abortion. By sensitizing the uterus to prostaglandin, the dose of prostaglandin can be reduced with a shortened prostaglandin-abortion interval. Administration of mifepristone in the early luteal phase of the cycle delays the development of a secretory endometrium. Preliminary studies suggest that it may be highly effective when given at this time as a post-coital contraceptive or 'once a month' pill. Although antigestagens offer great promise as agents to help regulate human fertility, their widespread use may be constrained more by religious and political factors, rather than by demonstration of clinical efficacy.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Alprostadil; Dinoprostone; Female; Humans; Mifepristone; Misoprostol; Pregnancy

The clinical effects were studied of two different PGE analogues on the uterine motility and cervical ripening of eighty pregnant women asking for a second trimester elective abortion for fetal abnormalities. Forty women received vaginal suppositories each containing 1 milligram of 16, 16-dimethyl-trans-s2-PGE1 (Gemeprost) every 3 hours (5 mg max). Intramuscular injections of 500 micrograms of 16-phenoxy-w 17, 18, 19, 20 tetranor PGE2 methyl-sulphonylamide (Sulprostone) were administered every four hours (2000 mcg max.) to the remaining forty patients. Thirty-three Gemeprost treated patients (82.5%) and 34 Sulprostone treated patients (85%) experienced a complete abortion in the mean of 12.92 +/- 6.95 hours and 11.88 +/- 6.8 hours respectively. The histological and ultrastructural findings of cervical ripening were similar in both groups, while the tocographic patterns showed different characteristics. Side effects occurred in 16 Sulprostone (40%), but only in 9 (22.5%) Gemeprost treated patients, demonstrating that Gemeprost, although equally effective, is better tolerated.. Researchers analyzed data on 80 pregnant women seeking a 2nd trimester abortion due to fetal abnormalities at the Federico II Medical School at the University of Naples in Italy to determine the effectiveness and side effects of 2 different prostaglandin analogues and their ability to bring about cervical ripening and uterine contractions. 40 women received 1 mg Gemeprost every 3 hours up to 5 mg in vaginal suppository form while the other 40 women who tended to be primigravidae received an intramuscular injection of 500 mcg Sulprostone every 4 hours up to 2000 mcg. Sulprostone achieved an 85% success rate and Gemeprost achieved an 82.5% success rate. Complete abortion occurred more quickly for multigravidae patients than it did for primigravidae patients (in hours, 10.6 vs. 16.5 for Gemeprost, p.1; 9.83 vs. 15.65 for Sulprostone, p.01). There was no statistically significant difference between the 2 treatment groups, however. Side effects were more common among Sulprostone patients than among Gemeprost patients (40% vs. 22.5%). The most common side effects among Sulprostone patients were, in descending order, abdominal pain (75%), diarrhea (50%), and nausea (50%). For Gemeprost patients, they were abdominal pain (55.5%) and headache (44.4%). In terms of uterine contractility, Sulprostone brought about hypertone more quickly than did Gemeprost (in minutes, 18.32 vs. 36.75; range 10-30 vs. 25-50). Gemeprost treatment was more like physiological labor than was Sulprostone treatment. Both prostaglandin analogues produced similar histological and ultrastructural findings of cervical ripening. These results indicated that the women were better able to tolerate Gemeprost.

Topics: Abortion, Induced; Adult; Alprostadil; Cervix Uteri; Dinoprostone; Female; Humans; Labor Onset; Microscopy, Electron; Pregnancy; Pregnancy Trimester, Second; Time Factors; Uterine Contraction

In 2115 women seeking voluntary termination of pregnancy after 49 days of amenorrhea or less, we studied the effect of a single 600-mg dose of mifepristone (RU 486), followed 36 to 48 hours later by the administration of one of two prostaglandin analogues, either gemeprost (1 mg by vaginal suppository) or sulprostone (0.25, 0.375, or 0.5 mg by intramuscular injection). The women were monitored for four hours after prostaglandin administration. Efficacy was indicated by the complete expulsion of the conceptus without the need of an additional procedure. All other results were considered failures, and the pregnancy was then terminated by a surgical method. The overall efficacy rate was 96.0 percent (95 percent confidence interval, 95.0 to 96.8). The failures included persisting pregnancies (1.0 percent), incomplete expulsions (2.1 percent), and the need for hemostatic procedure (0.9 percent). The mean time to expulsion was significantly shorter when sulprostone was given in the high dose (4.5 hours) than when it was given in the two lower doses (13.1 and 19.3 hours) or when gemeprost was given (22.7 hours). The mean duration of uterine bleeding was 8.9 days (range, 1 to 35); one woman received a blood transfusion. Most women had transient abdominal pain after receiving prostaglandin, but there were few other side effects. We conclude that the administration of mifepristone followed by a small dose of a prostaglandin analogue is an effective and safe method for the early termination of pregnancy.

Topics: Abortifacient Agents; Abortifacient Agents, Nonsteroidal; Abortion, Induced; Alprostadil; Dinoprostone; Drug Evaluation; Female; Humans; Mifepristone; Pregnancy; Retrospective Studies; Time Factors; Uterine Hemorrhage

The authors, using immunofluorescence, studied the effect of different prostaglandins (F2 alpha, E1, dimethyl PGE1) on cervical connective tissue. They analysed 80 biopsies which were carried out before and after the prostaglandins had been applied locally, both in pregnant and in non-pregnant women. The method showed that there were changes in the collagen fibres but not in fibronectin. On the other hand, there does not seem to be any difference in the collagen effect with the methods used: 1) between pregnant and non-pregnant women, and 2) between the different types of prostaglandin that were studied.

Topics: Adolescent; Adult; Aged; Alprostadil; Biopsy; Cervix Uteri; Dinoprost; Dinoprostone; Female; Fluorescent Antibody Technique; Humans; In Vitro Techniques; Middle Aged; Pregnancy; Prostaglandins; Prostaglandins E, Synthetic

The activity and side-effects of the prostaglandin derivatives, sulprostone and gemeprost were compared, 188 patients were studied, 90 receiving sulprostone 500 micrograms intramuscularly 16 hours pre-operatively and 98 receiving gemeprost 1 mg intravaginally 4 hours pre-operatively. Dilatation of the cervix of more than Hegar 8 was obtained in 80 per cent of the sulprostone group and in about 50 per cent in the gemeprost group. On dilatation before vacuum aspiration, little or no resistance was detected in nearly 80 per cent of both groups. Side-effects occurred in 39.3 per cent of the sulprostone group (usually abdominal pain), and in 22.6 per cent of the gemeprost group and here again abdominal pain was predominant. The results showed that with both sulprostone and gemeprost satisfactory dilatation of the cervix could be obtained. The somewhat better results with sulprostone are obtained at the expense of a higher incidence of side-effects. The administration of gemeprost was also better tolerated by the patients.. The cervical priming activity and side-effects of the prostaglandin derivatives sulprostone and gemeprost were compared in 188 women presenting for 1st-trimester pregnancy termination. In the sulprostone group, complete or incomplete abortion occurred in 19 (23%) patients and the cervical canal was dilated to more than Hegar 8 in 48 (57%) of patients, producing a success rate of 80%. The pretreatment was a partial success (Hegar 6-8) in 9% and a failure in another 11%. In the gemeprost group, premature abortion occurred in only 2 cases and the cervical canal could be dilated to more than 8 Hegar in 45 (48%) of patients, yielding a success rate of 50%. The pretreatment was a partial success in an additional 40% and a failure in 10%. On dilatation before vacuum aspiration, little or no resistance was observed in close to 80% of the women in both groups. Side-effects were recorded in 33 (39%) cases in the sulprostone group and in 21 (23%) cases in the gemeprost group; in both groups, abdominal pain was the most common such symptom. Overall, intramuscular injection of sulprostone and intravaginal administration of gemeprost resulted in satisfactory relaxation of the cervix, although sulprostone was somewhat more effective. On the other hand, the incidence of side-effects was twice as high among women in the gemeprost group.

Topics: Abortion, Induced; Administration, Intravaginal; Adult; Alprostadil; Cervix Uteri; Dinoprostone; Female; Gestational Age; Humans; Injections, Intramuscular; Pregnancy; Pregnancy Trimester, First; Prostaglandins E, Synthetic

The abortifacient effect has been compared of 15 me-PGF2 alpha, ONO 802 and 16 phenoxy-w-17,18,19,20-tetranor PGE2 given intra-muscularly, intravaginally and with or without laminaria dilatation of the cervix. Locally administered, 15 me-PGF2 alpha, proved to be more efficient than ONO 802. Laminaria had a beneficial effect on dilatation. Intramuscular administration involved the necessity of frequent injections and gastrointestinal side effects. A total of 143 patients participated in the study.. Synthetic analogues of prostaglandins (PGs) E and F are now being used widely to induce abortion at any point in pregnancy without surgical intervention. This study compared the abortifacient effect of PGE and PGF given intramuscularly, intravaginally, and with and without laminaria dilatation in 72 1st-trimester abortion patients. Pregnancy was terminated in 40 women through use of a single suppository containing 3 mg of 15-me-PGF2 beta: complete abortion occurred in 18 of the 20 pregnancies at 6-7 weeks gestation but in only 5 of the 20 pregnancies 10-12 weeks gestation. An additional 32 pregnancies at 6-7 weeks gestation were aborted through vaginal suppositories containing 1 mg of 16.16 dimethyltrans-delta 2-PGE1 methyl ether (ONO-802); complete abortion occurred in 24 of these women, within an average of 5-10 hours. Although suppositories containing 15-me-PGF2 beta were more effective than those with ONO-802, the number of side effects experienced was considerably lower with PGE2. Abortion, whether complete or incomplete, was associated in both groups with full cervical dilatation--a factor of significance in the prevention of future is thmicocervical insufficiency. Pregnancy was also terminated in 47 2nd-trimester patients given either intramuscular PGE2 methyl sulfonylamide or intramuscular 15-m3-PGF2 alpha. The abortion time was an average of 14.3 hours with PGE2 and 4.3 hours with PGF2 alpha; patients in both groups experienced severe low back pain of 25-30 seconds' duration. Complete abortion occurred in 3/4 of the PGF2 alpha women and 1/2 of the women receiving PGE2. Complete abortion was twice as likely in parous women than in primigravidae. The use of PGF2 was associated with no side effects, while PGE2 caused vomiting and diarrhea.

Topics: Abortifacient Agents; Abortifacient Agents, Nonsteroidal; Administration, Intravaginal; Alprostadil; Carboprost; Dinoprostone; Female; Humans; Infusions, Intravenous; Laminaria; Pregnancy; Pregnancy Trimester, First; Pregnancy Trimester, Second; Prostaglandins E, Synthetic; Prostaglandins F, Synthetic

Topics: Alprostadil; Animals; Dinoprostone; Drug Synergism; Ethanolamines; Female; In Vitro Techniques; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Rats; Uterine Contraction

The present study included 550 mainly primiparous women in the 8th to 12th week of pregnancy admitted to the hospital for termination of pregnancy. The patients were treated by different prostaglandin analogues or one medium size laminaria tent followed by vacuum aspiration. The treatment period was three hours, which for some analogues was extended to six and twelve hours. The prostaglandins studied were 15-methyl PGF2 alpha methyl ester (0.5 and 1.0 mg), 16,16-dimethyl-trans-delta 2 PGE1 methyl ester (1.0 mg), 9-deoxo-16,16-dimethyl-9-methylene PGE2 (30 mg), all administered by the vaginal route, and 16-phenoxy-omega-17,18, 19,20-tetranor PGE2 methyl sulfonylamide (0.25 and 0.5 mg) given as i.m. injections. At operation the degree of cervical dilatation, the amount of blood loss and other operative complications were registered. The patients were continuously supervised during treatment and during at least three hours after operation. Side effects, complications and vital signs were recorded. The degree of cervical dilatation was related to the duration of prostaglandin treatment. If the duration of prostaglandin treatment was prolonged, the frequency of gastrointestinal side effects, abortion prior to scheduled time for vacuum aspiration and pain needing analgesic treatment also increased. Both the efficacy and the frequency of side effects were dose dependent. The outcome of therapy after three-hour pretreatment was evaluated. All the prostaglandins were more effective than one medium size laminaria tent in dilating the cervical canal. The three E analogues were most effective. The number of patients with bleeding at operation of 50 ml or more was also higher following laminaria than following prostaglandin pretreatment. Most advantageous in this respect were the three E analogues. Frequency of gastrointestinal side effects and degree of pain following 9-methylene PGE2 and 16,16-dimethyl PGE1 methyl ester was the same as following laminaria treatment.

Topics: 16,16-Dimethylprostaglandin E2; Abortion, Induced; Alprostadil; Carboprost; Dinoprostone; Female; Humans; Laminaria; Pregnancy; Prostaglandins E, Synthetic; Seaweed