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| 1 - ABSTRACT:We report our experience with an alternate regimen, comprising a reduced dose of mifepristone in combination with vaginal misoprostol. A consecutive series of 2000 women requesting early medical abortion at gestations up to 63 days was studied retrospectively.
Each woman received mifepristone 200 mg orally, followed 36-48 h later by misoprostol 800 microg vaginally.
Of the 2000 women, 39 (2.0%) aborted completely following administration of mifepristone alone and a further 1912 experienced complete abortion following administration of misoprostol (a complete abortion rate of 97.5%). Surgical intervention was required in 49 women (2.5%): for incomplete abortion in 27 (1.4%), for missed abortion in seven (0.4%), for continuing pregnancy in 11 (0.6%) and to exclude ectopic pregnancy in four (0.2%).
The surgical intervention rate was significantly higher among women at gestations > or = 49 days than among those at < or = 49 days (3.3 versus 1.5%, P = 0.0193). The regimen appears as effective, in terms of high complete abortion rate and low continuing pregnancy rate, as any published alternative.
This regimen has the benefit of being less costly as the dose of mifepristone is 67% lower and misoprostol is substantially less expensive than gemeprost. Additionally, misoprostol does not require special transport or storage requirements. As such, the combination of mifepristone and misoprostol may be preferable to mifepristone and gemeprost.
NLM PUBMED CIT. ID: 9804263
SOURCE: Hum Reprod 1998 Oct;13(1O):2962-5.
| 1 - Résumé: Nous rapportons notre expérience avec un thérapie comprenant une dose réduite de mifepristone associée avec le misoprostol ( donné par voie vaginale ).
Une série consécutive de 2000 femmes souhaitant un avortement médical enceinte de 63 jours ou moins fut étudiée rétrospectivement.
Chaque femme a reçu 200 mg de mifepristone oralement, suivi 36 à 48 h après de misoprostol 800 microg par voie vaginale.
Des 2000 femmes, 39 (2.0%) ont avorté complètement à l'administration de mifepristone seule et 1912 avortements complets ont eu lieu après l'administration de misoprostol ( soit un taux d'avortement de 97.5%). Une intervention chirurgicale fut nécessaire chez 49 femmes (2.5%) pour avortement incomplet ou pour exclure une grossesse extra utérine ( 4 cas, soit 0.2%). Le taux chirurgical d'intervention fut nettement plus élevé parmi les femmes d'âge gestationnel > ou = 49 jours que parmi celles < ou = 49 jours (3.3% contre 1.5%, P = 0.0193).
Le traitement fut aussi efficace , en terme de taux d'avortement complet que d'autres alternatives publiées.
Ce régime a le bénéfice d'être moins coûteux puisque la dose de mifepristone est inférieure de 67% et que le misoprostol est substantiellement moins coûteux que le gemeprost. |
| 2 -ABSTRACT: The objectives of this study were to determine the effectiveness, side effects, and acceptability of one-third the standard 600 mg dose of mifepristone (200 mg) to induce abortion.
A prospective trial at seven sites enrolled women > or = 18 years, up to 8 weeks pregnant, and wanting an abortion. The women received 200 mg mifepristone orally, self-administered 800 micrograms misoprostol vaginally at home 48 h later, and returned 1-4 days later for ultrasound evaluation.
Surgical intervention was indicated for continuing pregnancy, excessive bleeding, persistent products of conception 5 weeks later, or other serious medical conditions.
Of the 933 subjects, 906 (97%) had complete medical abortions, 22 had surgical intervention, two were protocol failures, and three were lost to follow up. Of the 746 subjects who had no or minimal bleeding before misoprostol, 80% bled within 4 h and 98% within 24 h of using misoprostol.
By day 7, 95% of women had a complete abortion. Side effects were aceptable in 85% of subjects, and 94% found the procedure acceptable.
Low-dose mifepristone followed by vaginal misoprostol was highly effective as an abortifacient.
NLM PUBMED CIT. ID: 10342079
SOURCE: Contraception 1999 Jan;59(1):1-6.
| 2 -Résumé : Les objectifs de cette étude furent de déterminer l'efficacité, les effets secondaires, et l'acceptabilité du tiers de la dose standard de 600 mg de mifepristone (200 mg) pour induire l'avortement. Le travail fut réalisé dans sept centres et a concerné des femmes de 18 ans ou plus, désirant un avortement et pratiqué jusqu'à 8 semaines de grossesse. Les femmes ont reçu 200 mg de mifepristone par voie orale, et après 48 h, 800 micrograms de misoprostol par voie vaginale à placer à domicile. Elles revinrent 1 à 4 jours plus tard pour évaluation par échographie.
Une intervention chirurgicale fut indiquée pour grossesse persistante, saignement excessif, rétention après 5 semaines, ou pour d'autres conditions médicales sérieuses.
Des 933 sujets, 906 (97%) ont eu des avortements médicaux complets, 22 eurent une intervention chirurgicale, deux un échec du protocole, et trois furent perdues de vue. Des 746 sujets qui n'avaient aucun ou qui avaient un saignement minime avant le misoprostol, 80% saignèrent pendant 4 h et 98% pendant 24 h après le misoprostol.
Au jour 7, 95% de femmes avaient avorté complètement. Les effets secondaires furent acceptables chez 85% de sujets, et 94% ont trouvé la procédure valable.
Le faible dosage de mifepristone suivi par misoprostol vaginale fut hautement efficace comme moyen d'interruption.
NLM PUBMED CIT. ID: 10342079
SOURCE: Contraception 1999 Jan;59(1):1-6 |
3 - ABSTRACT:
OBJECTIVE: To assess the efficacy of a medical regimen for the termination of pregnancy within the gestational age range of 63 to 83 days.
DESIGN: Prospective observational study.
SETTING: Gynaecology department within a district general hospital.
POPULATION: Women attending the pregnancy advisory clinic between June 1996 and December 1997.
METHODS: The medical regimen used was mifepristone 200 mg orally followed after 36 to 48 h by misoprostol 800 microg administered vaginally.
MAIN OUTCOME MEASURES: The success rate of the medical termination of pregnancy regimen, where success was defined as achieving complete abortion without the need for secondary intervention by either surgical or repeat medical means.
RESULTS: Primary medical termination of pregnancy was chosen by 253 (80.8%) of the 313 women and was successful in 239 (94.5%). Repeat medical treatment achieved completion of the abortion in a further three women (1.2%) and surgical evacuation of the uterus was required in 10 (4.0%). One woman declined further intervention after failed medical treatment but subsequently miscarried.
CONCLUSIONS: The combination of mifepristone and misoprostol is effective for the termination of pregnancy for gestations of 63 to 83 days.
NLM PUBMED CIT. ID: 10426609
SOURCE: Br J Obstet Gynaecol 1999 Jun;106(6):535-9. |
Résumé:
OBJECTIF: Evaluer l'efficacité d'un régime médical pour l'interruption de grossesse dans la gamme d'âge gestationel de 63 à 83 jours.
ENVIRONNEMENT: Département Gynécologique d'un hôpital général de district.
POPULATION: Les femmes consultant pour interruption de grossesse entre Juin 1996 et Décembre 1997.
METHODES: Le traitement médical employé fut de 200 mg de mifepristone (un comprimé) suivi oralement après 36 à 48 h par misoprostol 800 microg par voie vaginale (4 comprimés).
CALCULS: Le taux de réussite de l'interruption médicale a été calculé lorsque l'avortement a été complet sans utilisation secondaire par l'un ou l'autre traitement chirurgical.
RESULTATS: L'interruption médicale de grossesse fut choisie en premier par 253 (80.8%) des 313 femmes et fut fructueuse chez 239 d'entre elles (94.5%). Le traitement médical fut répété pour achever l'avortement chez trois femmes (1.2%) et l'évacuation chirurgicale de l'utérus fut nécessaire dans 10 cas (4.0%). Une femme n'a pas souhaité recommencer le traitement médical qui avait échoué mais a fait une fausse couche postérieurement.
CONCLUSIONS: La combinaison de mifepristone - misoprostol est efficace pour l'interruption médicale de grossesse pour des gestations de 63 à 83 jours.
NLM PUBMED CIT. ID: 10426609
SOURCE: Br J Obstet Gynaecol 1999 Jun;106(6):535-9. |
4- ABSTRACT:
OBJECTIVE: To assess the effectiveness of a regimen comprising mifepristone followed by a combination of the vaginal and oral administration of misoprostol for mid-trimester medical termination of pregnancy.
DESIGN: Retrospective analysis of prospectively collected data in women undergoing mid-trimester medical termination of pregnancy.
SETTING: Aberdeen Royal Infirmary, Scotland.
SAMPLE: A consecutive series of 500 women with pregnancies of 13-21 weeks of amenorrhea undergoing legally induced abortion in one Scottish NHS hospital.
METHODS: Each woman received a single oral dose of mifepristone 200 mg and 36-48 h later vaginal misoprostol 800 microg. Three hours following the first dose of misoprostol, 400 microg doses were administered orally at three hourly intervals, to a maximum of four doses.
Success was defined as abortion occurring with five doses of prostaglandin, or within 15 h of administration of the first dose of prostaglandin.
RESULTS: Ninety-seven percent aborted successfully. The median dose of misoprostol required was 1200 microg and the median induction-to-abortion interval after first prostaglandin administration was 6.5 h. The median number of doses of misoprostol required to induce abortion, and the induction-to-abortion interval, was statistically significantly higher among women at gestations 17-21 weeks than among those at 13-16 weeks (P = 0.0001).
A total of 9.4% required surgical evacuation of the uterus under general anaesthesia and 66.4% of the women were managed as day cases.
CONCLUSIONS: The combination of oral mifepristone 200 mg followed by vaginally and orally administered misoprostol provides a noninvasive and effective regimen for second trimester termination of pregnancy.
NLM PUBMED CIT. ID: 10428528
SOURCE: Br J Obstet Gynaecol 1999 Jul;106(7):706-10. |
Résumé:
OBJECTIF: Evaluer l'efficacité d'un traitement comprenant mifepristone suivi par l'administration orale et vaginale de misoprostol pour l'intérruption médicale de grossesse au cours du deuxième trimestre.
ECHANTILLON: Une série consécutive de 500 femmes avec des grossesses de 13-21 semaines d'aménorrhée ayant eu un avortement légalement induit dans un hôpital Ecossais du NHS .
METHODES: Chaque femme a reçu une dose orale de mifepristone 200 mg et 36 à 48 h plus tard 800 microg de misoprostol par voie vaginale . Trois heures après la première dose de misoprostol, des doses de 400 microg furent données oralement à intervalles horaires de trois heures, avec un maximum de quatre doses.
La réussite fut établie si l'avortement survint soit avec cinq doses de prostaglandine, soit dans les 15 h après l'administration de la première dose de prostaglandine.
RESULTATS: 97% d'avortements eurent lieu. La dose médiane de misoprostol nécessaire fut de 1200 microg et la médiane horaire fut de 6.5 h. La médiane des doses de misoprostol nécessaire pour induire l'avortement, et la médiane horaire furent statistiquement considérablement plus élevées chez les femmes d'âge gestationnel de 17 à 21 semaines que parmi celles de 13 à 16 semaines (P = 0.0001).
Un total de 9.4% d'évacuation chirurgicale de l'utérus fut nécessaire sous anesthésie générale et 66.4% des femmes furent traitées en hopital de jour.
CONCLUSIONS: La combinaison de mifepristone 200 mg oral suivi par le misoprostol vaginal et oral est une thérapeutique non invasive, efficace pour l'avortement du deuxième trimestre de grossesse.
NLM PUBMED CIT. ID: 10428528
SOURCE: Br J Obstet Gynaecol 1999 Jul;106(7):706-10. |
5- ABSTRACT:
OBJECTIVE: To determine the efficacy of termination of pregnancy with a reduced oral dose of mifepristone and vaginal misoprostol.
DESIGN: A retrospective review of 369 medical terminations of pregnancy.
SETTING: Northern General Hospital, Sheffield, UK.
SUBJECTS: All women presenting for medical termination of pregnancy before 63 days gestation between October 1996 and December 1997.
INTERVENTIONS: Patients were pre-treated with mifepristone 200 mg orally, 36-48 hours before the prostaglandin E analogue, misoprostol, was administered vaginally. Two doses of misoprostol 400 micrograms, were given 2 hours apart. Women were allowed home 6 hours after the first dose of misoprostol. If the products of conception were not passed before going home, patients were to contact the hospital if bleeding did not take place within 4 days.
OUTCOME MEASURES: Need for a surgical procedure and number of ongoing pregnancies after full treatment were considered primary outcome measures.
RESULTS: A total of 369 women were treated with this regimen: 343 women (93.46%) aborted completely within a 6-hour observation period and did not require further intervention. A further 8 women aborted completely within the next 4 days. Overall, the complete abortion rate was 95.64%. Surgical intervention was necessary in 1.09% of the patients. No woman had serious complications.
CONCLUSION: This combination is effective, safe and cost-effective in a clinical setting.
NLM PUBMED CIT. ID: 11081141
SOURCE: S Afr Med J 2000 Sep;90(9):889-91.
6- ABSTRACT:
Until recently the medical abortion regimen of mifepristone followed by a suitable prostaglandin analogue two days later has been available in only a few countries. Limited access to the drug has hampered research and forced investigators without access to seek
alternatives. Where mifepristone has not been available, investigators have tested repeated doses of the prostaglandin misoprostol alone or in combination with methotrexate. However, these regimens cannot compete in efficacy, safety, and convenience with the mifepristone-prostaglandin regimen. The development of the mifepristone-prostaglandin regimen has continued since approval, and a more effective and better tolerated medical method than was available ten years ago can now be offered to women. Several randomized double-blind studies have demonstrated that the dose of mifepristone can be lowered to 200 mg, one-third of the original dose, without compromising efficacy. Misoprostol has now largely replaced other prostaglandin analogues in the regimen, and this has made medical abortion simpler and more cost effective. Although women prefer oral administration of drugs, recent evidence suggests that to achieve sufficient efficacy, misoprostol has to be administered vaginally in women beyond 49 days' gestation. This medical abortion regimen has proved to be acceptable to women and safe when provided under proper conditions.
NLM PUBMED CIT. ID: 10846322
SOURCE: J Am Med Womens Assoc 2000;55(3 Suppl):133-6, 150.
| 7- ABSTRACT:
The aim of this study was to compare the effectiveness, side effects, and acceptability of one-third the standard dose of mifepristone, i.e., 200 mg, and vaginal misoprostol 800 microg to induce abortion in subjects < or =56 days pregnant with subjects 57-63 days pregnant. A prospective multicenter trial enrolled healthy women > or =18 years, < or =63 days pregnant, and wanting an abortion. Women received mifepristone 200 mg orally, followed by misoprostol 800 microg vaginally, and returned 1-4 days later for ultrasound evaluation. A second dose of misoprostol was administered, if necessary.
Surgical intervention was indicated for continuing pregnancy, excessive bleeding, or persistent products of conception 5 weeks later. Of 1137 subjects, 829 were in the < or =56 days pregnant group and 308 in the 57-63 days pregnant group. In all, 34 subjects had surgical intervention and 16 were lost to follow-up.
Complete medical abortions occurred in 97% of subjects < or =56 days pregnant and 96% in the 57-63 days pregnant group. In all, 88% of subjects in the < or =56 days pregnant and 92% in the 57-63 days pregnant group bled within 4 h of using vaginal misoprostol.
Comparing subjects < or =56 days pregnant with 57-63 days pregnant, there was less diarrhea (20% vs 29%, p = 0.002) and vomiting (33% vs 44%, p = 0.001), although side effects were acceptable to 82% of subjects in both groups. One subject in the < or =56 day group required a transfusion for delayed excessive bleeding. Although bleeding (p = 0.01) and pain (p = 0.02) were less acceptable in the 57-63 day group, 91% of subjects in both groups reported that the overall procedure was acceptable.
In summary, low-dose mifepristone 200 mg and home administration of vaginal misoprostol 800 microg at 48 h were highly effective and acceptable to women < or =63 days pregnant, thereby expanding the number of women who can access a medical abortion.
NLM PUBMED CIT. ID: 10745068
SOURCE: Contraception 2000 Jan;61(1):41-6 |
Résumé:
L'objectif de cette étude fut de comparer l'efficacité, les effets secondaires, et l'acceptabilité d'une dose d'un tiers de la dose ordinaire de mifepristone, soit. 200 mg, et du misoprostol 800 microg vaginal pour induire un avortement chez des femmes enceintes de < ou =56 jours ou des femmes enceintes de 57 à 63 jours.
Des 1137 personnes, 829 étaient dans le groupe des femmes enceintes de < ou =56 jours et 308 dans le groupe des femmes enceintes de 57 à 63 jours.
Des 1137 personnes 34 eurent une intervention chirurgicale et 16 furent perdues de vue. Les avortements médicaux complets survinrent dans 97% des cas de < ou =56 jours et 96% des cas du groupe de 57 à 63 jours de grossesse.
88% des sujets dans le groupe de < ou =56 jours et 92% dans le groupe de 57-63 jours eurent des saignements dans les 4 h de l'utilisation du misoprostol vaginal.
Chez les sujets < ou =56 jours il y eu moins de diarrhées (20% vs 29%, p = 0.002) et de vomissements (33% vs 44%, p = 0.001) que chez les femmes du groupe 57-63 jours, bien que les effets furent acceptables pour 82 % des personnes dans les deux groupes.
Une personne dans le groupe < ou =56 jours a eu besoin d'une transfusion pour saignement excessif retardé. Bien que les saignements (p = 0.01) et les douleurs (p = 0.02) furent moins acceptables dans le groupe 57-63 jours, 91% des femmes dans les deux groupes ont trouvé que la procédure générale était acceptable.
En résumé, la mifepristone 200 mg et administration vaginale de misoprostol 800 microg à 48 h furent hautement efficaces et acceptables pour les femmes enceintes de < ou =63 jours , de ce fait le nombre de femmes qui peuvent accéder à l' avortement médical est augmenté.
NLM PUBMED CIT. ID: 10745068
SOURCE: Contraception 2000 Jan;61(1):41-6.
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8- ABSTRACT:
Multiple clinical studies demonstrate the efficacy of medical abortion with mifepristone or methotrexate followed by a prostaglandin analogue. However, assessing predictors of success, including regimen, is difficult because of regimen variability and a lack of direct comparisons.
This meta-analysis estimates rates of primary clinical outcomes of medical abortion (successful abortion, incomplete abortion, and viable pregnancy) and compares them by regimen and gestational age.
We identified 54 studies published from 1991 to 1998 using mifepristone with misoprostol (18), mifepristone with other prostaglandin analogues (23), and methotrexate with misoprostol (13). Data abstracted from studies included regimen details and clinical outcomes by gestational age.
We found that efficacy decreases with increasing gestational age (p<0.001), and differences by regimen are not statistically significant except at gestational age > or =57 days.
For gestations < or =49 days, mean rates of complete abortion were 94-96%, incomplete abortion 2-4%, and ongoing (viable) pregnancy 1-3%. For gestations of 50-56 days, the mean rate of complete abortion was 91% (same for all regimens), incomplete abortion 5-8%, and ongoing pregnancy 3-5%. For > or =57 days, success was lower for mifepristone/misoprostol (85%, 95% confidence interval 78-91%) than for mifepristone/other prostaglandin analogues 95% (CI 91-98%, p = 0.006). For mifepristone/misoprostol, using > or =2 prostaglandin analogue doses seems to be better than a single dose for certain outcomes and gestational ages.
We conclude that both mifepristone and methotrexate, when administered with misoprostol, have high levels of success at < or =49 days gestation but may have lower efficacy at longer gestation.
NLM PUBMED CIT. ID: 10745067
SOURCE: Contraception 2000 Jan;61(1):29-40.
| 9-ABSTRACT:
Mifepristone at a dose of 600 mg followed by 400 &mgr;g misoprostol orally has been used for early abortion by hundreds of thousands of women with success rates at </=49 days' gestation ranging from 92% to 97%.
Newer regimens may prove simpler than this standard regimen and may serve a larger number of patients.
Vaginal rather than oral administration of misoprostol may have advantages, including improvement in the efficacy of mifepristone regimens at >49 days' gestation. A lower mifepristone dose of 200 mg and in-home self-administration of misoprostol both appear safe and effective. Although most research protocols have used ultrasonography to confirm gestational age, the method can be provided safely without routine reliance on trasonography. Acceptability of the method to care providers and to patients has been high in all studies. The introduction of medical abortion into general medical practice in the United States will teach us much about the practical aspects of service provision.
NLM PUBMED CIT. ID: 10944369
SOURCE: Am J Obstet Gynecol 2000 Aug;183(2 Suppl):S44-53. |
Résumé:
La Mifepristone à la dose de 600 mg suivie de 400 mgr de misoprostol donnés oralement a été employée pour pratiquer des avortements précoces par des centaines de milliers de femmes enceintes de </=49 jours, avec des taux de réussite variant de 92% à 97%.
De nouveaux régimes peuvent se révéler plus simples que ce régime ordinaire et peuvent rendre service à un plus grand nombre de patientes.
L'administration orale plutôt que vaginale de misoprostol peut avoir des avantages, incluant l'amélioration de l'efficacité de la mifepristone au delà de 49 jours de grossesse. Un dosage de mifepristone de 200 mg et l'auto administration à la maison de misoprostol sont tous deux sûrs et efficaces. Bien que la plupart des protocoles ont employé l'ultrasonographie pour confirmer l'âge gestationel, la méthode peut être fournie avec sécurité sans échographie de routine. L'acceptabilité de la méthode a été jugée élevée par les patientes dans toutes les études. L'introduction de l'avortement médical dans la pratique médicale générale aux Etats-Unis nous enseignera beaucoup sur les aspects pratiques de ce service.
NLM PUBMED CIT. ID: 10944369
SOURCE: Am J Obstet Gynecol 2000 Aug;183(2 Suppl):S44-53. |
10-ABSTRACT:
The aim of this retrospective study was to compare the efficacy and complications associated with early medical and surgical pregnancy termination.
The study population comprised 932 consecutive women undergoing pregnancy termination at gestations of 63 days or less. There were no age or parity differences between the study groups.
Medical termination was performed with mifepristone 200 mg orally and misoprostol 800 ?g vaginally; surgical aspiration termination was performed under general anaesthesia. Outcome measures were: surgical curettage for presumed retained products of conception; ongoing pregnancy; and planned and emergency review in the unit. Early medical and surgical termination were associated with a 90.2 and 94.5% complete abortion rate respectively (P: = 0.025).
The complete abortion rate with medical termination decreased significantly with increasing parity; no such relationship with surgical abortion was found.
Women of parity three or more were less likely to have a complete abortion following a medical (83.3%) compared to surgical procedure (97.7%) (P: = 0.028). The ongoing pregnancy rate was 0.9% with medical and 0.5% with surgical termination (P: = NS).
Medical termination was associated with a lower complete abortion rate than surgical termination, particularly for women of higher parity. However, early medical termination allows over 90% of women to avoid the risks of surgical instrumentation of the uterus and anaesthesia.
NLM PUBMED CIT. ID: 11139539
SOURCE: Hum Reprod 2001 Jan;16(1):67-71.
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