Progesterone after mifepristone: A pilot prospective single arm clinical trial for women who have changed their mind after commencing medical abortion.

AIM: This pilot study aimed to assess the utility of an oral progesterone treatment protocol for women who commenced medical abortion and then changed their mind and wished instead to maintain their pregnancy. METHODS: The Progesterone-After-Mifepristone-pilot for efficacy and reproducibility (PAMper) trial was designed as a prospective single-arm pilot clinical trial, conducted via telehealth. Women aged 18 to 45 years in Australia who reported ingesting mifepristone within the last 72 h to initiate medical abortion and had not taken misoprostol were included. Initial contact was by a web-based form. Following informed consent, participants were prescribed oral progesterone to be taken 400 mg twice per day for 3 days then 400 mg at night until completion of a 19 day course. Pregnancy viability was assessed by ultrasound scan after 14 days of progesterone treatment. RESULTS: Between October 2020 and June 2021, nine women contacted the PAMper trial, of whom six enrolled and commenced progesterone treatment. These women reported ingesting mifepristone at 40-70 days of gestation, with progesterone being commenced within 5.7-72 h of mifepristone ingestion. Five participants had ongoing, live pregnancies at the primary endpoint (ultrasound at >2 weeks). One participant had a miscarriage after 9 days of progesterone treatment. There were no clinically significant adverse events. CONCLUSION: This small study demonstrated a clinically sound protocol for researching the use of progesterone-after-mifepristone for women in this circumstance. Results of this pilot study support the need for further larger scale trials in this field.

Deaths and Severe Adverse Events after the use of Mifepristone as an Abortifacient from September 2000 to February 2019.

OBJECTIVES: Primary: Analyze the Adverse Events (AEs) reported to the Food and Drug Administration (FDA) after use of mifepristone as an abortifacient. Secondary: Analyze maternal intent after ongoing pregnancy and investigate hemorrhage after mifepristone alone. METHODS: Adverse Event Reports (AERs) for mifepristone used as an abortifacient, submitted to the FDA from September 2000 to February 2019, were analyzed using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAEv3). RESULTS: The FDA provided 6158 pages of AERs. Duplicates, non-US, or AERs previously published (Gary, 2006) were excluded. Of the remaining, there were 3197 unique, US-only AERs of which there were 537 (16.80%) with insufficient information to determine clinical severity, leaving 2660 (83.20%) Codable US AERs. (Figure 1). Of these, 20 were Deaths, 529 were Life-threatening, 1957 were Severe, 151 were Moderate, and 3 were Mild.The deaths included: 9 (45.00%) sepsis, 4 (20.00%) drug toxicity/overdose, 1 (5.00%) ruptured ectopic pregnancy, 1 (5.00%) hemorrhage, 3 (15.00%) possible homicides, 1 (5.00%) suicide, 1 (5.00%) unknown. (Table 1).Retained products of conception and hemorrhage caused most morbidity. There were 75 ectopic pregnancies, including 26 ruptured ectopics (includes one death).There were 2243 surgeries including 2146 (95.68%) D&Cs of which only 853 (39.75%) were performed by abortion providers.Of 452 patients with ongoing pregnancies, 102 (22.57%) chose to keep their baby, 148 (32.74%) had terminations, 1 (0.22%) miscarried, and 201 (44.47%) had unknown outcomes.Hemorrhage occurred more often in those who took mifepristone and misoprostol (51.44%) than in those who took mifepristone alone (22.41%). CONCLUSIONS: Significant morbidity and mortality have occurred following the use of mifepristone as an abortifacient. A pre-abortion ultrasound should be required to rule out ectopic pregnancy and confirm gestational age. The FDA AER system is inadequate and significantly underestimates the adverse events from mifepristone.A mandatory registry of ongoing pregnancies is essential considering the number of ongoing pregnancies especially considering the known teratogenicity of misoprostol.The decision to prevent the FDA from enforcing REMS during the COVID-19 pandemic needs to be reversed and REMS must be strengthened.

Mifepristone Antagonization With Progesterone to Prevent Medical Abortion: A Randomized Controlled Trial.

OBJECTIVE: To estimate the efficacy and safety of mifepristone antagonization with high-dose oral progesterone. METHODS: We planned to enroll 40 patients in a double-blind, placebo-controlled, randomized trial. We enrolled patients at 44-63 days of gestation with ultrasound-confirmed gestational cardiac activity who were planning surgical abortion. Participants ingested mifepristone 200 mg and initiated oral progesterone 400 mg or placebo 24 hours later twice daily for 3 days, then once daily until their planned surgical abortion 14-16 days after enrollment. Follow-up visits were scheduled 3±1, 7±1, and 15±1 days after mifepristone intake with ultrasonography and blood testing for human chorionic gonadotropin and progesterone. Participants exited from the study when they had their surgical abortion or earlier for gestational cardiac activity absence, gestational sac expulsion, or medically indicated suction aspiration. We assessed the primary outcome of continued gestational cardiac activity at approximately 2 weeks (15±1 day), side effects after drug ingestion, and safety outcomes including hemorrhage and emergent treatment. RESULTS: We enrolled participants from February to July 2019 and stopped enrollment after 12 patients for safety concerns. Mean gestational age was 52.5 days. Two (one per group) voluntarily discontinued 3 days after mifepristone ingestion for subjective symptoms (nausea and vomiting, bleeding). Among the remaining 10 patients (five per group), gestational cardiac activity continued for 2 weeks in four in the progesterone group and two in the placebo group. One patient in the placebo group had no gestational cardiac activity 3 days after mifepristone use. Severe hemorrhage requiring ambulance transport to hospital occurred in three patients; one received progesterone (complete expulsion, no aspiration) and two received placebo (aspiration for both, one required transfusion). We halted enrollment after the third hemorrhage. No other significant side effects were reported. CONCLUSION: We could not estimate the efficacy of progesterone for mifepristone antagonization due to safety concerns when mifepristone is administered without subsequent prostaglandin analogue treatment. Patients in early pregnancy who use only mifepristone may be at high risk of significant hemorrhage. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03774745.

Mifepristone: a potential clinical agent based on its anti-progesterone and anti-glucocorticoid properties.

Nowadays, unwanted pregnancy is a major globe tragedy for millions of women, associated with significant direct and indirect costs, no matter for individuals or society. The progesterone receptor antagonist steroid, mifepristone has been widely and effectively using throughout the world for medical abortion, but to a lesser extent for emergency contraception. In this review, we hope to explore the role of mifepristone as a contraceptive, particularly for emergency contraception. Studies of mifepristone have also been expanding to the fields of endometriosis and uterine fibroids. Furthermore, this initially considered reproductive medicine has been investigated in some psychotic diseases and various disorders of hypercortisolism, because of its glucocorticoid receptor antagonism. Mifepristone was approved suitable for patients with hyperglycemia secondary to Cushing's syndrome by the United States Food and Drug Administration (FDA) in 2012. The aim of this article is to review published reports on the anti-progesterone and anti-glucocorticoid properties of mifepristone as a clinical agent. There is a new insight into systematically describing and evaluating the potential efficiency of mifepristone administrated in the field of endocrine and neuroendocrine, not only in obstetrics and gynecology.

Sonographic patterns of the endometrium in assessment of medical abortion outcomes.

BACKGROUND: We aimed to define endometrial pattern and endometrial thickness in predicting the outcome of early medical abortion. STUDY DESIGN: While blinded to outcomes of abortion, we retrospectively reviewed the ultrasound scan performed 14-21 days after medical abortion. We assessed the endometrial pattern and endometrial thickness. A total of 943 women at or before 56 days of gestation who underwent medical abortions were included. Abortion was induced with mifepristone (600 mg) orally followed 48 h later with oral misoprostol (600 mcg). A successful medical abortion was defined as complete abortion without surgical intervention. Three sonographic patterns (homogenous, heterogeneous and multilayered) were devised to correlate with the outcome. RESULTS: Of the 940 women, 92 (9.8%) had failed medical abortions. Eighty-seven (94.6%) patients with failed treatment outcomes had a heterogeneous pattern, while no patients with failed treatments had a multilayered pattern. Based on multivariable logistic regression, women who had an endometrial thickness in the range of 10-15 or >15 mm were more likely to have failed outcomes than those with a thickness <10 mm, with ORs of 3.69 (p=.001) and 8.82 (p<.001). Compared to those with a homogenous pattern, women with a heterogeneous endometrial pattern were more likely to have failed outcomes (OR 4.5, p=.003). In addition, an endometrial thickness >10 mm in combination with a heterogeneous pattern had the highest balanced accuracy in the prediction of failed outcome (81.9%; 95% CI, 77.6-86.3). CONCLUSION: Women with a multilayered pattern could be reassured that they have successful medical abortion, while those with a heterogeneous pattern and/or endometrium >10 mm may need follow-up. Sonographic endometrial pattern and endometrial thickness may serve as objective criteria in the management of early medical abortions.

[Medical termination of pregnancy in a patient with severe cystic fibrosis. Possible effect of the antiglucocorticoid action of mifepristone on the respiratory disease]. / Interruption médicale de grossesse chez une patiente atteinte d'une mucoviscidose sévère. Impact potentiel de l'effet antiglucocorticoïde de la mifépristone sur la pathologie respiratoire.

Better management of patients with cystic fibrosis has resulted in an increased rate of pregnancy, especially in mild forms. In case of severe respiratory impairment, physiological changes occurring during pregnancy can be life threatening. Medical termination of pregnancy may be necessary. We report a case of severe cystic fibrosis requiring a termination of pregnancy due to significant maternal risk at 17 weeks of gestation. Mifepristone used for induction of labor has a well-known antiglucocorticoid action. We discuss here its potential effect on the onset of an acute pulmonary failure in this patient with long-term corticosteroid therapy.

Medical versus surgical termination of pregnancy in primigravid women--is the next delivery differently at risk? A population-based register study.

OBJECTIVE: To compare the effect of medical versus surgical termination of pregnancy (TOP), performed in primigravid women, on subsequent delivery. DESIGN: Population-based register study. SETTING: Finland 2000-2009. POPULATION: All primigravid women (n = 8294) who underwent TOP during first trimester of pregnancy by medical (n = 3441) or surgical (n = 4853) method, and whose subsequent pregnancy resulted in singleton delivery. METHODS: The women were identified in the Finnish Register of Induced Abortions, and the data were linked to the Medical Birth and the Hospital Discharge Registries. MAIN OUTCOME MEASURES: Risk of preterm birth, low birthweight, small-for-gestational-age (SGA) infant and placental complications (placenta praevia, placental abruption, retained placenta, placenta accreta). RESULTS: No statistically significant differences in the incidences of preterm birth (4.0% in the medical group versus 4.9% in the surgical group), low birthweight (3.4% versus 4.0%), SGA infants (2.6% versus 2.9%) or placental complications (2.6% versus 2.8%) emerged between the two groups. After adjusting for various background factors, medical TOP was not associated with significantly altered risks of preterm birth (odds ratio [OR] 0.87, 95% confidence interval [95% CI] 0.68-1.13), low birthweight (OR 0.90, 95% CI 0.68-1.19), SGA infant (OR 0.87, 95% CI 0.64-1.20) or placental complications (OR 0.98, 95% CI 0.72-1.34) versus surgical TOP. In a sub-analysis excluding women who underwent surgical evacuation following the index TOP, medical TOP was associated with a reduced risk of preterm birth (P < 0.01), but the difference became insignificant after adjusting for gestational age at the time of TOP, inter-pregnancy interval, maternal age, cohabitation status, socio-economic status, residence and smoking during pregnancy. CONCLUSIONS: A history of one medical versus surgical TOP, performed in primigravid women, is associated with similar obstetric risks in the subsequent delivery.

Mifepristone: where do we come from and where are we going? Clinical development over a quarter of a century.

Administration of mifepristone followed by the prostaglandin, misoprostol, has been used successfully in the medical termination of pregnancy for over 25 years, and the method is registered in 35 countries. Single doses of mifepristone are also effective as an emergency postcoital contraceptive. Mifepristone administered for 3 months or longer to women with uterine leiomyomas, is associated with a reduction in pain and bleeding with improvement in quality of life and decrease in fibroid size. Mifepristone is also effective in decreasing pain in women with endometriosis. In both these conditions, serum estradiol levels are in the range of those in the early follicular phase. A daily dose of at least 2 mg mifepristone blocks ovulation. In contrast, weekly administration of 25 or 50 mg does not consistently block ovulation but has contraceptive potential by delaying endometrial development. Mifepristone in a dose of 200 mg, administered 48 h after the Luteinizing Hormone (LH) surge, also acts as a contraceptive, but this strategy is not practical for widespread use. Administration of mifepristone for 4-6 months or longer may lead to endometrial thickening. Endometrial histology reveals cystic glandular dilation together with admixed estrogen (mitotic) and progestin (secretory) epithelial effects. This histological pattern does not represent endometrial hyperplasia.

[Clinical study of terminating biochemical pregnancy and early clinical pregnancy with mifepristone and misoprostol].

OBJECTIVE: To explore the efficacy and safety of terminating biochemical pregnancy (the stage in which intrauterine or ectopic pregnancy cannot be confirmed) with mifepristone and misoprostol. METHODS: Mifepristone (150 mg) combined with misoprostol (600 microg) 3 days later were given to 500 biochemical pregnancies (G(1)), 500 early clinical pregnancies (G(2)) and 500 clinical pregnancies (G(3)) which were classified according to amenorrhea days, serum human chorionic gonadotropin-beta subunit (beta-hCG) and vaginal B-ultrasonic examinations. All were observed for 6 hours after taking misoprostol and returned for assessment per week. RESULTS: Expulsion of conceptus was G(1) 123 (24.6%, 123/500), G(2) 438 (87.6%, 438/500) and G(3) 467 (93.4%, 467/500). Failure rate was G(1) 6 (1.2%, 6/500), G(2) 24 (4.8%, 24/500) and G(3) 79 (15.8%, 79/500) for ongoing pregnancies, hospitalizations for suspected ectopic pregnancies and surgical intervention for heavy or long-time bleeding. Bleeding cases during the administration of mifepristone were G(1) 272 (54.4%, 272/500), G(2) 141 (28.2%, 141/500) and G(3) 87 (17.4%, 87/500); the mean bleeding days were G(1) (5.8 +/- 1.5), G(2) (9.0 +/- 2.9) and G(3) (14.3 +/- 5.9) days. Other side effects including abdominal pain, nausea, vomiting and diarrhea were low and light in each group, increasing with advancing gestational age. Menses recovery was 486 (97.2%, 486/500), 452 (90.4%, 452/500) and 433 (86.6%, 433/500) for each group on scheduled time. Satisfaction was 499 (99.8%, 499/500), 485 (97.0%, 485/500) and 369 (73.8%, 369/500) respectively. CONCLUSION: Mifepristone and misoprostol in combination is as safe, and effective for termination of biochemical pregnancies as ordinary medical abortion. It does not need to wait till ectopic pregnancy is excluded.

Risk factors for unsuccessful medical abortion with mifepristone and misoprostol.

BACKGROUND: The aim of this study was to determine the effectiveness of medical abortions with mifepristone and misoprostol following the approval of medical abortion in Israel. METHODS: A retrospective review of 377 consecutive medical records at an ambulatory care unit of a university medical centre was performed, screening all women undergoing medical abortion with mifepristone and misoprostol. Transvaginal ultrasonographic study and serum beta hCG measurement were performed 14-20 days after the procedure. The clinical outcome was defined as complete expulsion of intrauterine contents with (failed group) or without (successful group) surgical intervention. RESULTS: Surgical intervention was performed in 7.4% of patients. Residual products of conception were confirmed in 89%. Older age, previous spontaneous abortions, multigravidity, and earlier follow-up visit were independently associated with unsuccessful medical abortion. Significant differences were found in mean serum beta hCG and mean endometrial thickness in the successful versus failed procedure groups. CONCLUSIONS: Medical termination of pregnancy with mifepristone and misoprostol is >90% effective. High risk group for failure of the procedure can be characterised. An algorithm of follow up using follow-up visit date, serum beta hCG and sonographic endometrial stripe is suggested to define high risk patients for failed medical abortion.

Use of mifepristone and sublingual misoprostol for early medical abortion.

OBJECTIVE: Existing drug-induced abortion techniques involve oral administration of 200 mg of mifepristone, followed by oral administration of 600 microg of misoprostol 48 hours later, but the effects are variable. As revealed by recent research, sublingual and oral administrations of misoprostol are equally efficacious in terms of rapid absorption, but the former lasts longer in serum. Hence, in the near future, sublingual administration of misoprostol may become the most effective way to induce abortion. MATERIALS AND METHODS: Women with intrauterine pregnancy up to 49 gestational days received vaginal ultrasonography, followed by oral administration of mifepristone 200 mg and sublingual administration of misoprostol 600 microg 48 hours later. They returned for follow-up consultations 3 and 14 days after. The definition of a successfully induced complete medical abortion was that the abortion occurred without surgery or evacuating the uterus. RESULTS: A total of 356 women underwent medical abortion; the complete abortion rate was 98.3% (350 women). Medical abortion was unsuccessful in five (1.7%) women, who eventually had to undergo dilation and curettage. Patients found the side effects to be bearable; the reported satisfaction rate was 89.9% (325 women). CONCLUSION: Medical abortion for early termination of pregnancy should be achieved by oral administration of mifepristone, followed by sublingual administration of misoprostol.

Regimens of misoprostol with mifepristone for early medical abortion: a randomised trial.

OBJECTIVE: To compare the efficacy, adverse effects and acceptability of the three most common misoprostol regimens used with mifepristone for medical abortion. DESIGN: Randomised nonblinded trial. SETTING: Three clinics associated with major research universities in Canada; two in major urban areas and one in a periurban area. POPULATION: Women of reproductive age. METHODS: Consenting women presenting for abortion services with gestations less than 56 days and who met inclusion criteria were given 200 mg mifepristone orally and then randomised into three misoprostol study groups: (group I) 400 micrograms of oral misoprostol, (group II) 600 micrograms of oral misoprostol, and (group III) 800 micrograms of vaginal misoprostol. Misoprostol was self-administered at home 24-48 hours following mifepristone, and participants were instructed to take a second similar misoprostol dose at 24 hours after the initial dose if bleeding was less than a normal menstrual period. MAIN OUTCOME MEASURES: Successful abortion without surgery was 94.1%, with no significant differences across the three study groups (94.7% in group I, 93.4% in group II, and 94.3% in group III; P= 0.975). RESULTS: Efficacy and adverse effects did not differ significantly across the three study groups. Pain increased significantly across the study and the gestational age groups and was associated with lower acceptability. CONCLUSIONS: There appears to be a range of safe and effective options for early medical abortion with mifepristone including a choice between oral and vaginal administration of misoprostol.

Analysis of severe adverse events related to the use of mifepristone as an abortifacient.

BACKGROUND: The systematic analysis of morbidity and mortality for the Food and Drug Administration (FDA)-approved medical abortion regimen using mifepristone is possible using data from the FDA's Adverse Event Reporting System. OBJECTIVE: To assess mifepristone's mortality, morbidity, sentinel events, and quality of postmarketing surveillance using mifepristone adverse event reports (AERs). METHODS: Six hundred seven unique mifepristone AERs submitted to the FDA over a 4 year span were coded using the National Cancer Institute's Common Terminology Criteria for Adverse Events. Coding was based only on data in AERs and may underestimate severity and treatment rendered. Two board-certified obstetrician/gynecologists, the authors, made individual evaluations, compared them, and agreed upon final coding. RESULTS: The most frequent AERs were hemorrhage (n = 237) and infection (66). Hemorrhages included 1 fatal, 42 life threatening, and 168 serious cases; 68 required transfusions. Infections included 7 cases of septic shock (3 fatal, 4 life threatening) and 43 cases requiring parenteral antibiotics. Surgical interventions were required in 513 cases (235 emergent, 278 nonemergent). Emergent cases included 17 ectopic pregnancies (11 ruptured). Second trimester viability was documented in 22 cases (9 lost to follow-up, 13 documented fetal outcome). Of the 13 documented cases, 9 were terminated without comment on fetal morphology, 1 was enrolled in fetal registry, and 3 fetuses were diagnosed with serious malformations, suggesting a malformation rate of 23%. CONCLUSIONS: Hemorrhage and infection are the leading causes of mifepristone-related morbidity and mortality. AERs relied upon by the FDA to monitor mifepristone's postmarketing safety are grossly deficient due to extremely poor quality.

[Medical termination of pregnancy at 9-14 weeks gestation. Prospective study of 105 cases in Saint-Laurent-du-Maroni (French Guyana)]. / L'interruption volontaire de grossesse médicamenteuse de 9 à 14 semaines d'aménorrhée: étude prospective de 105 cas à Saint-Laurent-du-Maroni (Guyane française).

OBJECTIVES: To demonstrate the effectiveness and safety of mifepristone 600mg with misoprostol 800 mg, for termination of pregnancy at 9-14 weeks gestation. PATIENTS AND METHODS: This prospective study included 105 women at 9 to 14 weeks gestation given 800 mg of vaginal misoprostol, 2 or 3 days after a single dose of 600 mg of mifepristone for pregnancy termination. Outcomes measures included mean expulsion time, the interval between fotal and placental expulsion, adverse effects, vaginal bleeding, requirement for analgesia, and hospital stay, analyzed by parity and gestational age. RESULTS: Pregnancy termination was successful in 92.4% of the patients without requirement for surgery. The mean time to expulsion was 6 hours. The fetus and placenta were expelled together in 79% of the cases. In 15% the conception products were retained in the cervical canal, and removed with a ring forceps. Additional misoprostol doses were necessary in 33% and analgesia (nalbuphine sublingually, mean dose was 10mg) in 56%. Significant bleeding was observed in 7.5%, leading to curettage in 2 patients. No statistically significant differences were found between the rate of success and term (9-12 versus 12-14) or parity. CONCLUSION: Combining oral mifepristone and vaginal misoprostol is a successful alternative to surgical termination of pregnancy, even after 9 weeks' gestation. The use of nalbuphine for analgesia improves acceptability; sublingual administration helps avoid invasive procedures. Before 14 weeks gestation, the legal limit for termination of pregnancy in France, the choice between the surgical and medical alternatives should be left to the patient.

Medical treatment of ectopic pregnancies: a randomized clinical trial comparing methotrexate-mifepristone and methotrexate-placebo.

BACKGROUND: Medical treatment of ectopic pregnancies is common. To increase the efficacy of methotrexate, the association of mifepristone has been proposed. METHODS: We performed a large prospective multicentre double-blind sequential randomized trial in order to compare the efficacy of methotrexate and mifepristone (600 mg given orally) versus methotrexate and placebo. RESULTS: A total of 212 ectopic pregnancies was randomized. There was no significant difference in the initial characteristics between the two groups. There was no significant difference in the success rate of medical treatment between the methotrexate-mifepristone (n = 113) and the methotrexate-placebo group (n = 99): 79.6% (90/113) versus 74.2% (72/97) respectively, RR (95% CI): 1.07 (0.92-1.25), P = 0.41, non-significant. However, there was a quantitative interaction between progesterone level and effect of treatment: when progesterone level was >/=10 ng/l, the efficacy of the combination of mifepristone and methotrexate was significantly higher than the combination of methotrexate and placebo, with an 83.3% success rate (15/18) versus 38.5% (5/13) respectively. CONCLUSIONS: Our study failed to demonstrate any benefit of the addition of mifepristone to methotrexate. By contrast, the quantitative interaction between treatment effect and baseline serum progesterone suggested that this combination could be limited to ectopic pregnancies associated with high serum progesterone concentrations.

Gestational trophoblastic tumor after medical abortion.

BACKGROUND: Nonmetastatic gestational trophoblastic tumor occurring after early elective medical abortion using mifepristone and misoprostol is unusual. CASE: A young woman at 6 to 7 weeks' gestation presented with brown spotting requesting medical abortion. Pretreatment ultrasound was consistent with an abnormal pregnancy. Passage of tissue ensued after mifepristone-misoprostol administration. Recovery was normal, with a postabortion ultrasound on day 16 showing a reduction in intracavitary contents. The patient declined surveillance with serial beta-human chorionic gonadotropin (beta-hCG) levels and was lost to follow-up. Sixty days after initial treatment, she presented to a hospital with a history of intermittent bleeding and underwent curettage, revealing a complete hydatidiform mole. Chemotherapy was instituted when levels of hCG plateaued. Complete hCG regression occurred after three weekly injections of methotrexate, and postmolar surveillance is uneventful to date. CONCLUSION: Gestational trophoblastic tumor may occur after early medical abortion.

[Medical methods for pregnancy termination. A review of literature and its potential role in Mexico and Latin America]. / Medicamentos para la interrupción de la gestación: una revisión de la literatura y sus posibles implicaciones para México y América Latina.

In this document, we review the relevant aspects of the different medical methods of abortion. We describe the principal medical regimens currently used in North America, Europe, and a growing number of developing countries. We also describe specific treatment regimens (which usually involve a combination of two drugs), physiological methods of action, potential side effects and complications, method requirements, including follow-up visits, any existing contraindication, and acceptability of these methods among patients. Finally, we comment on the potential role of medical abortion in Mexico and throughout Latin America.

A randomized comparison of medical abortion and surgical vacuum aspiration at 10-13 weeks gestation.

BACKGROUND: Since 1991, mifepristone in combination with a prostaglandin analogue has been licensed for termination of pregnancy in the UK at up to 9 weeks amenorrhoea, and since 1995, beyond 13 weeks. Surgical methods are used almost exclusively at 10-13 weeks amenorrhoea. METHODS: A patient-centred, partially randomized, controlled trial was carried out. Those who expressed a strong preference for either medical (n = 15) or surgical (n = 62) abortion were allocated to that method. The remainder agreed to be randomized. The medical method (n = 188) was mifepristone 200 mg followed by misoprostol up to 3 doses, and surgery (n = 180) was by vacuum aspiration under general anaesthesia. Outcome measures included efficacy rates, medical complications within 8 weeks of the procedure, patient preferences and acceptability. RESULTS: Among women who underwent medical abortion, 5.4% required a second procedure compared with 2.1% who had surgery, although this difference was not statistically significant. Side effects experienced were higher in women who underwent medical abortion compared with those who underwent surgery. There were no significant differences in the rates of major complications up to 8 weeks. Prior to termination, 80% of women had a preference for a method, with 72% preferring medical and 28% preferring surgical abortion. Following abortion, 70% of those who underwent medical termination and 79% who underwent surgery would opt for the same method in the future. CONCLUSION: Medical abortion is safe and effective at 10-13 weeks gestation and should be considered an option for those women who wish to avoid surgery and anaesthesia.

Medical management of early fetal demise using a combination of mifepristone and misoprostol.

BACKGROUND: This study aims to assess the efficacy of a combination of mifepristone and misoprostol in the management of missed miscarriage and anembryonic pregnancy. METHODS: Data of 220 consecutive women with miscarriage, undergoing medical evacuation of the uterus were collected prospectively at an early pregnancy assessment unit in a tertiary referral hospital. 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, two further doses of misoprostol, 400 microg each, were administered vaginally or orally at 3 h intervals. Women who failed to pass products of conception were offered repeat medical regime with misoprostol. Success was defined as complete uterine evacuation within 3 days, without the need for surgical evacuation. RESULTS: The overall success rate of medical management was 84.1%. Mifepristone alone induced natural expulsion of products of conception in 18.1% of women. The median dose of misoprostol required was 1600 microg and the median induction miscarriage interval after first prostaglandin administration was 8.04 h (range: 0.58-50.54 h). Of the 142 women who were symptomatic at presentation the medical regime failed in 30 (21.1%), compared with five (6.4%) failures of the 78 who were asymptomatic (P = 0.007). Of the 35 women who had surgical evacuation, eight required an emergency curettage for bleeding. CONCLUSIONS: The combination of oral mifepristone 200 mg with vaginal or oral misoprostol is an alternative to surgical management of early fetal demise, although it is not as effective as surgery.