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Objective: To evaluate the introduction of an early medical abortion program with methotrexate and misoprostol, using a standardized protocol. Methods: A total of 1973 women at 34 Planned Parenthood sites participated in a case series of early medical abortion. Ultrasound was used to confirm gestational age of less than 49 days from the first day of the last menstrual period. Women were given intramuscular methotrexate 50 mg/m2 of body surface area on day 1, and then they inserted misoprostol 800 μg vaginally at home on day 5, 6, or 7. Women were advised to have a suction curettage if the pregnancy appeared viable 2 weeks after methotrexate or if any gestational sac persisted 4 weeks after methotrexate. Outcomes were complete medical abortion and suction curettage. Results: Sixteen hundred fifty-nine women (84.1%) had a complete medical abortion, and 257 (13.0%) had suction curettage. The most common reason for curettage was patient option (8.9%). At 2 weeks after methotrexate use, 1.4% of women had curettage because of a viable pregnancy; at 4 weeks, 1.6% of women had curettage because of a persistent but nonviable pregnancy. One percent of women had curettage because of physician recommendation, most commonly for bleeding. Suction curettage rates decreased with site experience (P < .006) and were lower at early gestational ages (P < .004) and in nulliparous women (P < .004). Conclusion: Medical abortion with methotrexate and misoprostol is safe and effective and can be offered in a community setting.

Although medical termination of pregnancy is available in Europe and China as an alternative to surgical termination, political and social factors have blocked medical approaches to pregnancy termination in the United States. Methotrexate, which is toxic to trophoblastic tissue, has been used safely to treat unruptured ectopic pregnancies. This report describes the use of a single low dose of methotrexate followed by intravaginal misoprostol for the medical termination of early pregnancy.Women seeking termination of pregnancy were selected for this study on the basis of their good general health, emotional stability, and a pregnancy of 63 days or less in duration. Each woman received an intramuscular dose of methotrexate (50 mg per square meter of body-surface area). Five to seven days later, 800 micrograms of misoprostol was administered intravaginally. If abortion did not occur after seven days, the women was offered a second dose of misoprostol or vacuum aspiration. Successful abortion was defined as a complete termination of pregnancy within seven days after the first or second administration of misoprostol.A total of 171 of the 178 women enrolled in the study (96 percent) had successful medical abortions. Twenty-five women (14 percent) did not have an abortion after the first dose of misoprostol and received a second dose. Eighteen subsequently had complete abortions, but seven required suction curettage. In all seven women who required suction curettage, there was histologic evidence of disruption in the conceptus. No important side effects or complications were noted.The combination of methotrexate and misoprostol represents a safe and effective alternative to invasive methods for the termination of early pregnancy.Methotrexate, which is toxic to trophoblastic tissue, has been used safely to treat unruptured ectopic pregnancies. This report describes the use of a single low dose of methotrexate followed by intravaginal misoprostol for the medical termination of early pregnancy. Women seeking termination of pregnancy at the Mount Sinai Medical Center, New York City, were selected on the basis of their good general health, emotional stability, and a pregnancy of 63 days or less in duration. Each woman received an intramuscular dose of methotrexate (50 mg per square meter of body-surface area). 5-7 days later, 800 mcg of misoprostol (4 x 200 mcg) was administered intravaginally. If abortion did not occur after 7 days, the woman was offered a 2nd dose of misoprostol or vacuum aspiration. Successful abortion was defined as a complete termination of pregnancy within 7 days after the 1st or 2nd administration of misoprostol. A total of 171 of the 178 women enrolled in the study (96%) had successful medical abortions. 25 women (14%) did not have an abortion after the 1st dose of misoprostol and received a 2nd dose. 18 subsequently had complete abortions, but 7 required suction curettage. In all 7 women who required suction curettage, there was histologic evidence of disruption in the conceptus: trophoblastic changes that ranged from mild hydropic degeneration to almost complete dissolution of the trophoblast. On the basis of the women's reports, 88% appeared to have had abortions within 24 hours, which claim was confirmed by vaginal ultrasound examination. More than 75% of the women had little pain or only moderate pain (or= 2 on a scale from 0 to 4+). No important side effects or complications occurred. The patients overwhelmingly preferred the medical termination of pregnancy to the surgical method. The combination of methotrexate and misoprostol represents a safe and effective alternative to invasive methods for the termination of early pregnancy.

In the first 18 months since mifepristone was approved by the Food and Drug Administration (FDA) for use with misoprostol for early medical abortion, approximately 80,000 women have been treated. One-hundred thirty-nine adverse events were reported to Danco Laboratories LLC and subsequently reported to the FDA. Thirteen patients required blood transfusions, 10 patients were treated with antibiotics for infection and 6 had a generalized allergic reaction. Fifty patients had an ongoing pregnancy, with 48 having suction curettage, leaving 2 ongoing pregnancies. Thirty-nine patients had a suction curettage for heavy or prolonged vaginal bleeding. The overall national experience has been highly favorable.

To provide evidence regarding the safety, efficacy, and acceptability of 200 mg mifepristone followed by home administration of 400 mug oral misoprostolThe 376 women enrolled in this prospective, open-label, multicenter trial were administered mifepristone in the clinic and were given 2 tablets of 200 mug misoprostol to swallow at home 48 hours later. On day 15, women returned to the clinic for a gynecologic examination. Success was defined as a complete termination without surgical intervention or additional misoprostol by day 21. All participants completed an exit interview before discharge from the studyOf the women enrolled, 58.8% had gestations of between 43 and 49 days, 54.7% had had a previous abortion, and 76% had had a previous pregnancy. Of the 354 women included in the efficacy analysis, 324 (91.5%) had a successful termination. The most common adverse effects reported by patients were pain or cramps (93.2%) and nausea (66.6%), followed by weakness (54.7%), headache (46.2%), and dizziness (44.4%). Overall acceptability of the regimen was high, with 63.3% of women reporting that it was very satisfactory and an additional 23% reporting that it was satisfactoryA regimen of 200 mg mifepristone followed in 48 hours by home administration of 400 mug oral misoprostol is effective, associated with rare severe adverse effects or adverse events, and acceptable for women seeking medical abortion of pregnancies of up to 49 days duration as compared with the regimen currently approved by the Food and Drug Administration.III.

The HLA antigens of 136 patients with gestational diabetes are compared with control populations. No significant variations are observed in their frequencies, particularly for those antigens associated with Type 1 diabetes mellitus. Islet cell antibodies have also been studied in the serum of 52 of these patients and 20 of them were positive, whereas only one of 37 pregnant nondiabetic women had such antibodies (chi 2 = 15.2). A very high association between ICA and DR3 and DR4 was encountered (chi 2 = 17, with two df); half of the patients positive for either one of these antigens were ICA positive. These results indicate that ICA associates equally with DR3 and DR4, against the hypothesis that this expression of autoimmunity is more a characteristic of DR3- than of DR4-associated genetic susceptibility. These patients will be followed to determine if the ICA+ individuals are at increased risk for the development of insulin-dependent diabetes.

Techniques, complications, abortion counselling, and contraception. A review of some of the unique problems presented in the termination of unwanted pregnancies in adolescents.

Of 51 patients more than 2 years beyond the menopause 34 had a diagnosis of endometrial carcinoma. Any with liver involvement were not included. 14 were found to have abnormal glucose metabolism. Each patient received an intravenous infusion of 8 mcc of bata-6 7H-3 dissolved in 10 cc of 10% propylene glycol. 96 hour urine collections were obtained by an indwelling catheter. Values for the recovery of radioactivity associated with estrone estradio estriol and estriol/estrone + estradiol expressed in percent of injected radioactivity are given. A wide range of values was obtained and great variations in ratios. Generally the results were similar to those obtained from studies on menstruating females. There was no significant difference between patients with or without endometrial carcinoma in terms of recovered radioactivity or of the estriol quotient. However methoxgestrone epiestriol and the alpha-ketols which make up a significant portion of theurinary metabolites of estradiol 17 beta were not studied. Restudy of 6 patients with carcinoma produced constant patterns of metabolism. A significantly lower specific activity of estriol as compared to that of estrone was demonstrated in both groups of patients when estradiol 17 beta had been administered. However this difference was less precursons of urinary estriol. Androstenedione may be one of these. Reasonable radiochemical purity of each final metabolite was verified by recrystallization to constant specific activity following the addition of nouradioactive estrone or estriol.

Two sisters and a brother, all exhibiting sex chromosome mosaicism, were studied. An estrogen-producing gonadoblastoma was resected from one sister and there was presumptive evidence that a similar tumor had been removed from the other sister. Surgical exploration of the brother revealed the presence of a testis, a uterus, and a vagina. The importance of cytogenic investigation of various gynecologic disorders is stressed.

In the past 10 years urinary estriol excretion in the pregnant human female has been utilized as an index of fetoplacental health with increasing frequency. However, most investigators have failed to demonstrate a major improvement in neonatal mortality rates when this assay has been used. The intra-amniotic instillation of 200 mg. of dehydroepiandrosterone has been shown to bring about a pronounced rise in urinary estriol excretion. This indicates that the various enzyme systems in fetus and placenta are not fully saturated at term and that there is considerable metabolic reserve.

Prenatal detection of chromosome mosaicism has always been a diagnostic dilemma. In 21 reported cases of chromosomal mosaicism in cultured amniotic fluid cells, only two cases had cytogenetic confirmation of the mosaicism. All 21 pregnancies resulted in either phenotypically normal liveborns or grossly normal abortuses. We report a case of XO/XY mosaicism detected prenatally and confirmed postnatally in a grossly normal male infant. The indication for prenatal cytogenetic diagnosis was advanced maternal age (38 years). A diagnosis of XO/XY mosaicism was made from two separate culture flasks of amniotic fluid cells, with 45,X cells predominating (86.4 %). The Y chromosome was of normal size but carried no fluorescent band. The parents were counseled and were advised that the phenotype of XO/XY mosaicism can range from relative normality to sexual maldevelopment. They decided to continue this pregnancy. The infant was born at term and was a grossly normal male with normal penis and descended, normal-sized testes. Leukocyte culture from the cord blood and a skin fibroblast culture confirmed the mosaicism of XO/XY. The father's Y chromosome was of identical size and carried a small fluorescent band. It appears that an altered Y chromosome may be predisposed to anaphase lag leading to mosaicism.

Two groups of 58 gestational diabetic women matched for age, prepregnancy weight, height, and parity were studied. The home glucose monitoring study group performed fasting and 1-hour postprandial capillary blood glucose testing after every meal. The control group was followed by conventional treatment. The incidence of macrosomia (birth weight of greater than or equal to 4000 gm) and large (greater than or equal to 90%) for gestational age infants was significantly reduced in the home glucose monitoring group. The mean birth weight of the study group was 3231 +/- 561 gm, while that of the control group was 3597 +/- 721 gm (p less than 0.002). Significantly more patients in the home glucose monitoring group were receiving insulin therapy (50% versus 21%). We believe that intensive home glucose monitoring will allow for the early identification of those gestational diabetic patients needing insulin and thus reduce the incidence of macrosomia and large for gestational age infants.

The clinical importance of maternal urinary estriol excretion has been amply demonstrated in the past. The source of the vastly increased amount of estriol in pregnancy still remains in doubt. The fetal adrenal gland appears to be a major source of estrogen precursors. A woman pregnant with an anencephalic fetus which has an absent or atrophic fetal adrenal cortex received tritiated dehydroepiandrosterone sulfate during a control period and during adrenal suppression. In contrast to the normal pregnancy, the maternal adrenal gland continues to provide estrogen precursors near term.

60 mg., followed by delivery of the fetus under general anesthesia employing hyperventilation. Under general anesthesia, a stillborn male was delivered by cesarean section. Three hours later, after mechanical ventilation was discontinued, she slowly regained consciousness, opening her eyes to painful stimulation. By the following morning, she had continually improved, her blood pressure was 130/70 and urine contained 50 mg. of albumin. Mannitol 50 Gm. and methyl prednisolone 40 mg. every 6 hours were continued. Twenty hours after delivery both pupils were equal and reactive, extraocular movements complete, and papilledema was receding. She was alert, oriented, and responding to complex commands. Lumbar punctures 12 and 24 hours following delivery revealed normal pressures and no cells. By the fourth postdelivery day, the patient was afebrile, normotensive, and fully alert without neurological deficit. An appropriate antituberculous regimen was maintained.