Jill L. Schwartz

Early pregnancy failure--current management concepts.

Approximately one in four women will experience a miscarriage during her lifetime. For more than 50 years, the standard management of early pregnancy failure has been a dilatation and curettage (D & C). Typically, the procedure is performed in an operating room, which significantly increases cost. There is little objective information in the modern literature to prove that a D & C for all patients will lower morbidity or improve emotional well being. Treatment options include expectant management, D & C in an outpatient setting, and medical management with misoprostol (not approved by the U.S. Food and Drug Administration for treatment of early pregnancy failure). The medical literature supports that expectant management may result in more complications, including the need for “emergent” curettage, if clinicians do not understand the true normal course of expectant management. In general, women prefer some form of active management. Dilatation and curettage can be performed safely in the office or other outpatient setting using manual vacuum aspiration. Vaginal misoprostol will cause expulsion in 80% to 90% of women up to 13 weeks’ uterine size or gestation, including patients who have a gestational sac present. However, these data come from only three trials involving a total of 42 subjects treated with vaginal misoprostol, and another study of 42 women who received vaginal misoprostol for “missed abortion” before a scheduled D & C. There is a significant lack of information from large-scale studies about when treatment is necessary and the relative efficacy, rates of side effects, and acceptability of these various treatment options for early pregnancy failure. Target Audience: Obstetricians & Gynecologists, Family Physicians Learning Objectives: After completion of this article, the reader will be able to summarize the current literature on the management of early pregnancy failures, describe the various management options for patients with early pregnancy failures, and contrast the efficacy and complications of each management option.

Mifepristone followed on the same day by vaginal misoprostol for early abortion

Abstract We performed a pilot study to examine the clinical efficacy of mifepristone 200 mg followed on the same day by misoprostol 800 μg vaginally in women with pregnancies up to 49 days gestation. Forty women received mifepristone 200 mg after which they self-inserted misoprostol intravaginally 6 to 8 h later at home. Participants returned for an evaluation, including transvaginal ultrasonography, 24 ± 1 h after using the misoprostol. Participants who had not aborted received a second dose of misoprostol to administer 48 h after the mifepristone. All participants returned approximately 2 weeks after receiving mifepristone. At 24 h after receiving misoprostol, 37/40 (92%, 95% CI 81–98%) had ultrasonographic evidence of complete abortion. By follow-up 2 weeks after the mifepristone, 40/40 (100%, 95% CI 92–100%) women were felt to have complete abortions. One subject subsequently had a suction aspiration for an incomplete abortion on study Day 44. Nausea, vomiting, diarrhea, and warmth/chills occurred in 38%, 13%, 13%, and 60%, respectively. This pilot study suggests that mifepristone 200 mg, followed on the same day by misoprostol 800 μg vaginally, effects abortion at rates comparable to regimens using the standard time interval of 48 h between medications.

A randomized trial of the effect of moistening misoprostol before vaginal administration when used with methotrexate for abortion

A prospective multicenter, randomized trial was performed to evaluate if moistened misoprostol results in a more rapid abortion and a higher rate of complete abortion compared with dry misoprostol when administered intravaginally for medical abortion after methotrexate. A total of 240 pregnant women < or = 49 days gestation seeking elective abortion received 50 mg/m2 methotrexate intramuscularly followed 5-6 days later by 800 micrograms misoprostol vaginally. The misoprostol dose was repeated in 1-2 days if the abortion did not occur. Group 1 moistened the misoprostol before administration and group 2 used dry tablets. There was no statistically significant difference in the cumulative rate of abortion after the first misoprostol dose (73.0% vs 71.3%, p = 0.87), second misoprostol dose (84.1% vs 81.1%, p = 0.65), or by 35 days after methotrexate administration (95.2% vs 91.8%, p = 0.40) between groups 1 and 2, respectively. The proportion of subjects with embryonic cardiac activity 2 weeks after methotrexate injection was greater in group 2 (5.7%, 95% confidence interval [CI] 1.0%, 9.9%) than in group 1 (2.4%, 95% CI 0%, 5.0%), although not statistically significant (p = 0.21). The immediate success rate in Pittsburgh was greater, albeit not statistically, for the women that moistened the misoprostol (87% vs 76%, p = 0.19); these rates were also not statistically different in Havana (82% vs 86%, p = 0.62). The rate of side effects after methotrexate was not different between groups but women in group 1 had significantly more diarrhea (36% vs 21%, p = 0.02) and fever/warmth/chills (44% vs 30%, p = 0.04). Moistening misoprostol before vaginal administration in a medical abortion regimen with methotrexate does not statistically improve efficacy. This trial demonstrates the importance of prospective, randomized studies to prove the relative efficacy of any medical abortion treatment regimen.

Predicting risk of ovulation in new start oral contraceptive users.

OBJECTIVE To assess ovarian follicular development and ovulation rates in women starting to take oral contraceptives (OC) on menstrual cycle day 1, 4, or 7. METHODS One hundred thirty women starting treatment with OC were randomized to begin use of ethinyl estradiol, 30 μg, plus norgestrel, 300 μg, on menstrual cycle day 1 (group 1), 4 (group 2), or 7 (group 3). Follicular development was assessed by vaginal ultrasonography on menstrual cycle days 7, 14, 21, and 28, and serum progesterone levels were measured on menstrual cycle days 21 and 28. At a .05 level of significance (two‐tailed) and power of 80%, 84 participants were required to complete the study. Eighty‐five women who met study criteria, made minimal dosing errors, and underwent at least three ultrasonographic examinations were analyzed. RESULTS A follicle‐like structure that reached a maximum diameter over 13 mm was observed in three of 29 (10.3%), five of 29 (17.2%), and 12 of 27 (44.4%) women in groups 1, 2 and 3, respectively (P = 0.003). The median maximum follicle size for each group was 9.0 mm, 9.0 mm, and 12.0 mm for start day 1, 4, and 7 respectively (P < .001). Evidence of ovulation based on serum progesterone was present in two, one, and zero women in groups 1, 2, and 3, respectively (P = .2). CONCLUSION Although a delay in oral contraceptive initiation results in significantly more ovarian follicular development, the postponement does not appear to increase actual ovulation rates.

The trimonthly combination oral contraceptive regimen : Is it cost effective ?

The extended use of combination oral contraceptive pills (COCPs) to decrease the frequency of withdrawal bleeding can be convenient and beneficial to women. We conducted a cost-effective analysis comparing the standard regimen (21 days of estrogen/progestin) to a trimonthly regimen (84 days of estrogen/progestin) followed by a pill-free week for 1-year. The economic savings for patient out-of-pocket expenses from decreased sanitary product usage as a result of nine fewer withdrawal bleeding episodes is offset by the cost of three extra packages of COCPs from the trimonthly regimen. On the basis of an average use of 18 tampons per month, the trimonthly regimen is cost effective when the patient cost per package of pills is less than

Single and multiple exposure tolerance study of polystyrene sulfonate gel: a phase I safety and colposcopy study

9.45. The trimonthly regimen is also cost effective when the sanitary product usage is in the higher range; an above average use of 48 tampons per month is cost effective when the patient cost per package of pills is less than

Efficacy of mifepristone followed on the same day by misoprostol for early termination of pregnancy: report of a randomised trial.

25.20. Therefore, the trimonthly regimen may be useful for women with menorrhagia, but for the average women, the qualitative benefits of less frequent withdrawal bleeding need to be weighed against an increase in cost.