title: Overview and expert assessment of off-label use of misoprostol in obstetrics and gynaecology: review and report by the Collège national des gynécologues obstétriciens français.
abstract: The literature suggests that misoprostol can be offered to patients for off-label use as it has reasonable efficacy, risk/benefit ratio, tolerance and patient satisfaction, according to the criteria for evidence-based medicine. Both the vaginal and sublingual routes are more effective than the oral route for first-trimester cervical dilatation. Vaginal misoprostol 800μg, repeated if necessary after 24 or 48h, is a possible alternative for management after early pregnancy failure. However, misoprostol has not been demonstrated to be useful for the evacuation of an incomplete miscarriage, except for cervical dilatation before vacuum aspiration. Oral mifepristone 200mg, followed 24-48h later by vaginal, sublingual or buccal misoprostol 800μg (followed 3-4h later, if necessary, by misoprostol 400μg) is a less efficacious but less aggressive alternative to vacuum aspiration for elective or medically-indicated first-trimester terminations; this alternative becomes increasingly less effective as gestational age increases. In the second trimester, vaginal misoprostol 800-2400μg in 24h, 24-48h after at least 200mg of mifepristone, is an alternative to surgery, sulprostone and gemeprost. Data for the third trimester are sparse. For women with an unripe cervix and an unscarred uterus, vaginal misoprostol 25μg every 3-6h is an alternative to prostaglandin E2 for cervical ripening at term for a live fetus. When oxytocin is unavailable, misoprostol can be used after delivery for prevention (sublingual misoprostol 600μg) and treatment (sublingual misoprostol 800μg) of postpartum haemorrhage. The use of misoprostol to promote cervical dilatation before diagnostic hysteroscopy or surgical procedures is beneficial for premenopausal women but not for postmenopausal women. Nonetheless, in view of the side effects of misoprostol, its use as a first-line treatment is not indicated, and it should be reserved for difficult cases. Misoprostol is not useful for placing or removing the types of intra-uterine devices used in Europe, regardless of parity.
authors.affiliation: Pole de Gynécologie Obstétrique, Médecine fœtale, Médecine et Biologie de la Reproduction, Centre Hospitalo-Universitaire de Tours, Hôpital Bretonneau Faculté de Médecine de Tours, François Rabelais, Tours, France. Electronic address: marret@med.univ-tours.fr.
authors.forename: H
authors.initials: H
authors.lastname: Marret
authors.affiliation: UMR Inserm U 930, Université François Rabelais, Tours, France.
authors.forename: E
authors.initials: E
authors.lastname: Simon
authors.affiliation: Service de Gynécologie Obstétrique et Médecine de la Reproduction, CHU de Caen, Caen, France.
authors.forename: G
authors.initials: G
authors.lastname: Beucher
authors.affiliation: Service de Gynécologie Obstétrique et Médecine de la Reproduction, CHU de Caen, Caen, France.
authors.forename: M
authors.initials: M
authors.lastname: Dreyfus
authors.affiliation: Département de Gynécologie-Obstétrique, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
authors.forename: A
authors.initials: A
authors.lastname: Gaudineau
authors.affiliation: Inserm, UMR1027, Épidémiologie Périnatale, Handicap de l'enfant, Santé des Adolescents, Toulouse, France; Service de Gynécologie-Obstétrique, Hôpital Paule de Viguier, CHU Toulouse, Toulouse, France.
authors.forename: C
authors.initials: C
authors.lastname: Vayssière
authors.affiliation: Service de Gynécologie-Obstétrique, CHU du Kremlin-Bicêtre, Le Kremlin-Bicêtre, France.
authors.forename: M
authors.initials: M
authors.lastname: Lesavre
authors.affiliation: Service de Centre Hospitalo-Universitaire deniversitaire Augustin-Morvan, Brest, France.
authors.forename: M
authors.initials: M
authors.lastname: Pluchon
authors.affiliation: Service de Gynécologie Obstétrique, Centre Hospitalo-Universitaire de Nantes, Nantes, France.
authors.forename: N
authors.initials: N
authors.lastname: Winer
authors.affiliation: Service de Gynécologie-Obstétrique, CHU du Kremlin-Bicêtre, Le Kremlin-Bicêtre, France.
authors.forename: H
authors.initials: H
authors.lastname: Fernandez
authors.affiliation: Service de Pharmacologie Clinique et Centre Régional de Pharmacovigilance, CHRU de Tours, Tours, France.
authors.forename: J
authors.initials: J
authors.lastname: Aubert
authors.affiliation: Service de Pharmacologie Clinique et Centre Régional de Pharmacovigilance, CHRU de Tours, Tours, France.
authors.forename: T
authors.initials: T
authors.lastname: Bejan-Angoulvant
authors.affiliation: Service de Pharmacologie Clinique et Centre Régional de Pharmacovigilance, CHRU de Tours, Tours, France.
authors.forename: A P
authors.initials: AP
authors.lastname: Jonville-Bera
authors.affiliation: Pô1e d'Obstétrique, Hôpital Jeanne de Flandre, CHRU de Lille, Lille, France.
authors.forename: E
authors.initials: E
authors.lastname: Clouqueur
authors.affiliation: Pô1e d'Obstétrique, Hôpital Jeanne de Flandre, CHRU de Lille, Lille, France.
authors.forename: V
authors.initials: V
authors.lastname: Houfflin-Debarge
authors.affiliation: Service de Gynécologie Obstétrique et Médecine de la Reproduction, CHU de Poitiers, Poitiers, France.
authors.forename: A
authors.initials: A
authors.lastname: Garrigue
authors.affiliation: Service de Gynécologie Obstétrique et Médecine de la Reproduction, CHU de Poitiers, Poitiers, France.
authors.forename: F
authors.initials: F
authors.lastname: Pierre
mesh_terms: D000020:Abortifacient Agents, Nonsteroidal; D000028:Abortion, Induced / Q000379:methods; D000282:Administration, Intravaginal; D000286:Administration, Sublingual; D020070:Cervical Ripening; D005260:Female; D005313:Fetal Death; D005602:France; D005865:Gestational Age; D006176:Gynecology / Q000379:methods*; D006801:Humans; D016595:Misoprostol / Q000008:administration & dosage*; D009774:Obstetrics / Q000379:methods*; D056687:Off-Label Use; D006473:Postpartum Hemorrhage / Q000188:drug therapy; D011247:Pregnancy
chemical_list: D000020:Abortifacient Agents, Nonsteroidal; D016595:Misoprostol
keywords: Elective abortion; Hysteroscopy; Medically-indicated termination of pregnancy; Miscarriage; Misoprostol