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M D Creinin

Publications and source records attributed to M D Creinin.

At least 37 records · Page 2Linked to original sources
PubMed1999

"Pop-out" method of levonorgestrel implant removal.

The "pop-out" technique is a method of levonorgestrel implant removal that uses digital pressure to direct implants through a small skin incision. This technique was developed, theoretically, to cause less bruising and patient discomfort by avoiding the use of instruments. The pop-out technique is the primary method used for levonorgestrel implant removal in the Magee-Womens Hospital resident clinic. We performed a retrospective analysis of levonorgestrel implant removals performed between July 1, 1995, and December 31, 1998. Of the 168 removals included in this analysis, 38 were performed by one of two attending physicians, and 130 were performed by the residents with attending supervision. The average time for removal was 12 +/- 5 min (range 2.25-27 min) when the "pop-out" method could be used to remove all six implants, and 14 +/- 7 min (range 2.25-59 min) for all removals. The removal time for residents was inversely proportional to the anticipated level of difficulty of the removal and to the number of previous removals performed. The removal time was significantly faster when residents were supervised by one of the attending physicians as compared with the other attending physician. Only 0.7% (7/1,008) of levonorgestrel implants were fragmented during removal. This review shows that the "pop-out" method is a reasonable alternative to other proposed methods of primary implant removal. The difference in the level of expertise of the attending physician may significantly influence removal time when training clinicians in levonorgestrel implant removal.

Adolescent↗
PubMed1999

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 $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 $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.

Contraceptives, Oral, Combined↗
PubMed1999

Screening for factor V Leiden mutation before prescribing combination oral contraceptives.

OBJECTIVE: To evaluate the cost-effectiveness of screening for factor V Leiden mutation in women in the United States who use combination oral contraceptives. DESIGN: Cost-effectiveness analysis. SETTING: A national research reference laboratory, a university medical center, and an academic health center managed care organization. PATIENT(S): Women of reproductive age in the United States. INTERVENTION(S): Baseline risk estimates of venous thromboembolic disease in the general population and in carriers of factor V Leiden mutation were calculated using available data. MAIN OUTCOME MEASURE(S): The number of women who would require factor V Leiden testing and the cost of identifying this cohort to prevent one death caused by venous thromboembolic disease before prescribing combination oral contraceptives. RESULT(S): To prevent one venous thromboembolic death attributable to the use of oral contraceptives in women with factor V Leiden mutation, >92,000 carriers would need to be identified and stopped from using these pills. The estimated charge to prevent this one death would exceed $300 million. If the price of testing were discounted to 34.5% of current charges, the cost still would be between $105 million and $130 million. CONCLUSION(S): Screening for factor V Leiden mutation before prescribing combination oral contraceptives is not a cost-effective use of U.S. health care dollars. The best and most cost-effective screening tool we have is taking a thorough personal and family history related to venous thromboembolic events.

Adult↗
PubMed1999

Conception rates after abortion with methotrexate and misoprostol.

OBJECTIVE: To evaluate the fertility of a cohort of women within 1 year after receiving methotrexate and misoprostol for early abortion. METHODS: Participants in a clinical trial of medical abortion were contacted at 1-6 months and approximately 12 months after the study abortion to obtain fertility information. For both interviews, subjects were asked about sexual activity, contraception used since the abortion, and any pregnancies (and their outcomes) since the abortion. RESULTS: Ninety-three (81.6%) of 114 subjects were able to be contacted. Follow-up intervals ranged from 1 to 19 completed months (median 11 months) after the study abortion. During the follow-up period, 23 (24.7%) women became pregnant; none had been attempting to achieve pregnancy. One patient had a normal term delivery, one had a spontaneous abortion and the remainder had elective abortions. CONCLUSIONS: Women who have a medical abortion with low-dose intramuscular methotrexate and vaginal misoprostol remain at high risk for unintended pregnancy.

Abortifacient Agents, Nonsteroidal↗
PubMed1999

Methotrexate and misoprostol for early abortion in adolescent women.

STUDY OBJECTIVE: Investigate the potential effectiveness, side effects, and acceptability of medical abortion in female adolescents. DESIGN: Multicenter cohort study. SETTING: Magee-Womens Hospital (Pittsburgh, PA) and University of British Columbia (Vancouver, BC, Canada). PARTICIPANTS: Twenty-five pregnant adolescents less than 18 years old up to 49 days' gestation. INTERVENTIONS: Methotrexate, 50 mg/m2 intramuscularly, followed 5 to 6 days later by misoprostol, 800 micrograms vaginally, self-administered at home. Misoprostol administration was repeated by a doctor if abortion did not occur within 1 or 2 days. Acceptability was assessed before methotrexate injection and at follow-up 5 weeks later. MAIN OUTCOME MEASURES: Successful abortion (complete abortion without requiring a surgical procedure), immediate success (abortion within 24 hours of initial or repeat misoprostol administration), and acceptability. RESULTS: Complete abortion occurred in 24 of 25 (96%; 95% confidence interval [CI], 88%-100%) subjects. Immediate success abortion occurred in 23 (92%; 95% CI, 81%-100%) of these young women; the remaining subject who aborted did so on study day 10. The single failure was an incomplete abortion. Of the 23 participants who completed the follow-up acceptability evaluation, 4 (17%) believed that the process was a negative experience; 83% of participants would choose this same method again for a future abortion if needed and would recommend this method to a friend. Those who would not try this method again were without support of another individual at the time of the abortion. CONCLUSIONS: This medical abortion regimen is effective in adolescents. The overall acceptability in adolescents is similar to that reported for women 18 years of age or older. To minimize the likelihood of a negative experience with this abortion method in adolescents, home support for these patients should be evaluated during pretreatment counseling.

Abortifacient Agents, Nonsteroidal↗
PubMed1998

Methotrexate effects on trophoblast and the corpus luteum in early pregnancy.

OBJECTIVE: Our purpose was to determine whether methotrexate affects the trophoblast or corpus luteum when administered for abortion. STUDY DESIGN: A randomized controlled trial was performed in women requesting an abortion up to 49 days' gestation. Twenty patients were treated with intramuscular methotrexate 50 mg/m2 (10 women) or 60 mg/m2 (10 women). Serum beta-human chorionic gonadotropin, progesterone, and 17-hydroxyprogesterone levels were determined at baseline and then serially after methotrexate administration for the first 24 hours, then every 24 hours for 7 days. On the seventh day misoprostol 800 microg was administered vaginally. RESULTS: Serum beta-human chorionic gonadotropin increased at a lower rate than occurs in normal pregnancy. Progesterone levels averaged 56.9 +/- 19.8 nmol/L at baseline and 45.5 +/- 20.5 nmol/L (P = .01) 1 week after methotrexate. Progesterone decreased in 16 women over the 7 days and increased in the other 4; these latter women all aborted after a single dose of misoprostol. Levels of 17-hydroxyprogesterone plateaued during the first day after methotrexate administration; both progesterone and 17-hydroxyprogesterone declined simultaneously between the third and fourth day after methotrexate. CONCLUSIONS: Methotrexate most likely primarily affects trophoblast production of human chorionic gonadotropin, as evidenced by a blunting of the expected increase in serum beta-human chorionic gonadotropin resulting in less support for the production of progesterone by the corpus luteum. However, changes in progesterone levels after methotrexate administration were inconsistent and are unlikely to represent the ultimate effect of methotrexate in abortion. The less-than-normal increase in serum beta-human chorionic gonadotropin levels after methotrexate administration is most likely a result of disruption of cytotrophoblast syncytialization. This disruption may be the true effect of methotrexate in destabilizing the implantation site of an early pregnancy.

17-alpha-Hydroxyprogesterone↗
PubMed1998

Effects of methotrexate on trophoblast proliferation and local immune responses.

Methotrexate is a folic acid analogue that has been used successfully for the treatment of ectopic pregnancy and, in conjunction with misoprostol, for medical abortions of early intrauterine pregnancies. To administer the most efficacious treatment requires knowledge of the mechanism underlying the induction of methotrexate-induced abortion. This study was designed to ascertain trophoblast integrity, proliferation and differentiation following administration of methotrexate. In addition, to determine if methotrexate affects the local uterine immune response, we ascertained the numbers and identities of decidual leukocytes following treatment. Ten women with undesired intrauterine pregnancies of 42-49 days gestation were recruited to receive methotrexte 50 mg/m2 i.m. A suction aspiration was performed 7 days later. Tissues from gestational age-matched elective surgical abortions were used as controls. Additionally, specimens from women who received methotrexate and misoprostol for abortion in a clinical trial of oral methotrexate in combination with misoprostol, who had a suction abortion because of continued embryonic cardiac activity 14 days after the methotrexate, were evaluated. Immunoreactivity to proliferating cell nuclear antigen and cyclin D3 antibodies was used to demonstrate a marked reduction in the proliferation index of cytotrophoblasts from methotrexate-treated abortions. Methotrexate treatment failures and non-treated pregnancies had a much higher proliferation index. There was no direct destruction of the syncytiotrophoblast, as indicated by the continued presence of human placental lactogen and beta-human chorionic gonadotrophin proteins. A decrease in the total number of leukocyte cells was observed in the decidua of methotrexate-treated samples, with the large granular lymphocyte (LGL) cells showing the greatest decline in numbers. Our conclusions from this study are that methotrexate acts primarily to derail the normal developmental programme of the trophoblast stem cell population, as well as to decrease LGL cell numbers in the decidua.

Adult↗
PubMed1997

Methotrexate pharmacokinetics and effects in women receiving methotrexate 50 mg and 60 mg per square meter for early abortion.

OBJECTIVE: Our goal was to evaluate the pharmacokinetics and safety of methotrexate in doses of 50 mg/m2 and 60 mg/m2 in regimens for early abortion. STUDY DESIGN: A randomized controlled trial was performed in women requesting an abortion at < or = 49 days' gestation. Twenty women were treated with intramuscular methotrexate 50 mg/m2 (group 1) or 60 mg/m2 (group 2). Methotrexate levels were determined serially for the first 24 hours, then every 24 hours for 7 days. On the seventh day misoprostol 800 microg was administered vaginally. The misoprostol dose was repeated 24 hours later if abortion did not occur. RESULTS: Complete abortion occurred in 9 of 10 (90%, 95% confidence interval 56% to 100%) patients in group 1 and all 10 (100%, 95% confidence interval 69% to 100%; p = 0.99) in group 2. Methotrexate levels peaked within 1 to 2 hours and were nondetectable within 48 hours in all patients in group 1 and 72 hours in group 2. Both the maximum concentration of methotrexate and the area under the curve were significantly greater for group 2. Methotrexate clearance rates were 7.89 +/- 1.98 L/hr and 5.55 +/- 0.83 L/hr (p = 0.003), respectively. CONCLUSIONS: The serum levels of intramuscular methotrexate with 50 mg/m2 and 60 mg/m2 regimens indicate that these are safe treatment doses. Methotrexate 50 mg/m2 intramuscularly has the same clearance rates when administered during pregnancy as in a nonpregnant state, and maximum concentrations do not reach sustained toxic levels.

Abortifacient Agents, Nonsteroidal↗
PubMed1997

Effect of nonsteroidal anti-inflammatory drugs on the action of misoprostol in a regimen for early abortion.

Nonsteroidal anti-inflammatory drugs are frequently avoided by some investigators in protocols for medical abortion because of a concern over potential inhibition of prostaglandin action on uterine contractions. To evaluate the effects of nonsteroidal anti-inflammatory drugs on uterine cramping and resultant pregnancy expulsion, analgesic use by 449 participants with gestational age of < or = 56 days in three previously reported medical abortion trials involving methotrexate and misoprostol was reviewed. Subjects from each of the three trials were included in this analysis only if they received 50 mg/m2 methotrexate intramuscularly followed 3 or 7 days later by 800 micrograms misoprostol vaginally. Misoprostol administration was repeated if the abortion did not occur after the first misoprostol dose. A total of 416 subjects met the study criteria. For the women who took a nonsteroidal anti-inflammatory drug after the first dose of misoprostol, 132/246 (53.7%) aborted within 24 h. For those that did not take a nonsteroidal anti-inflammatory drug, 83/170 (48.8%, p = 0.38) aborted within 24 h. Similarly, 27/56 (48.2%) of the women who took a nonsteroidal anti-inflammatory drug aborted within 24 h of the second dose of misoprostol. However, only 32/145 (22.1%, p = 0.002) of the women who did not take a nonsteroidal anti-inflammatory drug aborted. Use of a nonsteroidal anti-inflammatory drug does not interfere with the action of misoprostol to induce uterine contractions and pregnancy expulsion in women receiving methotrexate and misoprostol for early abortion.

Abortifacient Agents, Nonsteroidal↗
PubMed1997

Medical abortion with methotrexate 75 mg intramuscularly and vaginal misoprostol.

Methotrexate (50 mg/m2 intramuscularly and 50 mg orally) followed by vaginal misoprostol have proven to be > 90% effective at causing abortion in women at less than 49 days' gestation. Although the effectiveness of the oral dose (which has a lower serum bioavailability) demonstrates that a methotrexate dose of 50 mg/m2 may be more than necessary, an intramuscular regimen is more advantageous because it is less costly. This trial was designed to investigate the potential effectiveness of a single dose of methotrexate, 75 mg intramuscularly, in a regimen for early abortion. One hundred subjects received 75 mg methotrexate intramuscularly followed 5 to 6 days later by 800 micrograms misoprostol vaginally. The misoprostol dose was repeated if the abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), duration of vaginal bleeding, and side effects. One subject was lost to follow-up. Complete abortion occurred in 94 of 99 (94.9%, 95% CI 90.6, 99.3%) patients. The complete abortion rate was no different for earlier gestations: 38 of 40 (95.0%, 95% CI 88.2, 100%) at up to 42 days' gestation and 56 of 59 (94.9%, 95% CI 89.3, 100%) at more than 42 days' gestation (p = 0.99). Abortion occurred in the 24 h following the initial or repeat misoprostol dose (immediate success) in 70.7%; the remaining 24.2% of women who aborted did so after a delay of 22 +/- 10 days (mean + standard deviation). Vaginal bleeding lasted 17 +/- 8 days and 11 +/- 7 days in immediate success and delayed success patients, respectively. Overall, 77.8%, 86.9%, and 91.9% of patients had passed the pregnancy by 14, 28, and 35 days, respectively, after receiving methotrexate. This preliminary evaluation demonstrates that a medical abortion regimen using 75 mg methotrexate intramuscularly appears to have similar effectiveness to one with 50 mg/m2 methotrexate.

Abortifacient Agents, Nonsteroidal↗
PubMed1997

Medical treatment of ectopic pregnancy with methotrexate.

OBJECTIVE: To review our experience with low-dose IM methotrexate for the medical management of ectopic pregnancy (EP). DESIGN: Retrospective chart review. SETTING: Magee-Womens Hospital, Pittsburgh, Pennsylvania. PATIENT(S): The first 50 women treated by the resident service in whom EP was diagnosed and treated with methotrexate. INTERVENTION(S): Intramuscular methotrexate, 50 mg/m2. Serum beta-hCG was evaluated 4 and 7 days after treatment and then weekly thereafter. The dose was repeated if the beta-hCG level did not drop > or = 15% between days 4 and 7 or if a plateau or rise was noted during weekly follow-up evaluation. Surgery was performed if significant abdominal pain occurred in the presence of hemodynamic instability or signs of peritoneal irritation on physical examination. MAIN OUTCOME MEASURE(S): Resolution of the EP without surgical intervention. RESULT(S): Two patients were lost to follow-up and one was treated without a certain diagnosis of EP. Forty-three of the remaining 47 women (91.5%; 95% confidence interval, 83.5%, 99.5%) were treated successfully with methotrexate. Of these, 36 women were treated with a single dose, and 7 required a second dose. Four women were treated surgically after medical management failed. The time from initiation of treatment to cure in women who were treated successfully was 25 +/- 15 days (mean +/- SD). Thirteen patients (27.7%) made additional visits to the emergency department because of increased abdominal pain. CONCLUSION(S): As medical therapy for EP becomes common practice, familiarity with its side effects may lead to greater success rates. The decision to abandon medical treatment and proceed with surgery should be based on defined guidelines, such as the development of peritoneal signs, decreasing hemoglobin levels, or hemodynamic instability.

Abdominal Pain↗
PubMed1997

Medical abortion with oral methotrexate and vaginal misoprostol.

OBJECTIVE: To evaluate the safety and efficacy of oral methotrexate and vaginal misoprostol for medical abortion. METHODS: A prospective multicenter trial involved 300 women up to 49 days' gestation seeking elective abortion. Subjects received methotrexate 50 mg orally followed 5-6 days later by misoprostol 800 micrograms vaginally. The misoprostol dose was repeated if abortion did not occur. RESULTS: Complete abortion occurred in 273 of 299 women (91.3%; 95% confidence interval [CI] 87.5, 94.2%); one woman was lost to follow-up. Abortion occurred within 8 days of the methotrexate in 233 women (77.9%; 95% CI 72.8, 82.5%); the remaining 13.4% of women who aborted did so after a delay of 23.5 +/- 9.8 days (median 23 days, range 10-45). Vaginal bleeding lasted an average of 15 and 11 days in immediate and delayed-success abortions, respectively. Complete abortion rates decreased linearly with increasing body surface area. After methotrexate and misoprostol administration, nausea was reported in 37% and 33%, vomiting in 11% and 18%, diarrhea in 12% and 18%, and subjective fever or chills in 15% and 31% of subjects, respectively. CONCLUSION: Oral methotrexate followed by vaginal misoprostol is effective for abortion and represents an acceptable alternative to intramuscular methotrexate in regimens for medical abortion.

Abortifacient Agents, Nonsteroidal↗
PubMed1997

Misoprostol for medical evacuation of early pregnancy failure.

OBJECTIVE: To determine whether misoprostol (a prostaglandin E1 analogue) 400 micrograms orally (group 1) or 800 micrograms vaginally (group 2) will cause complete uterine evacuation in women with early pregnancy failure. METHODS: Twenty subjects were recruited for a prospective, non-blinded, randomized clinical trial. Early pregnancy failure was diagnosed by transvaginal ultrasound examination; only women with a closed cervical os and minimal vaginal bleeding were enrolled. Subjects returned 24 hours after misoprostol administration for a transvaginal ultrasound examination. If the gestational sac was still present, the misoprostol dose was repeated and the subject returned again 24 hours later. Subjects who failed to expel the pregnancy were offered a suction curettage. RESULTS: Twelve and eight women were randomized to groups 1 and 2, respectively. Complete uterine evacuation occurred in three of 12 [25%, 95% confidence interval (CI) 1%, 50%] and seven of eight (88%, 95% CI 65%, 100%, P = .010) subjects in groups 1 and 2, respectively. Vomiting occurred in 30% and 13%, respectively, and diarrhea in 50% and 38%, respectively. CONCLUSION: Vaginal misoprostol 800 micrograms is more effective than oral misoprostol 400 micrograms for uterine evacuation of early pregnancy failure and may be an effective alternative to dilation and curettage.

Abortifacient Agents, Nonsteroidal↗
PubMed1997

A reassessment of efficacy of the Yuzpe regimen of emergency contraception.

This review discusses the available data reporting the efficacy of emergency contraceptive treatment with the Yuzpe regimen (0.2 mg of ethinyl oestradiol in combination with either 2.0 mg of norgestrel or 1.0 mg of levonorgestrel) and evaluates the true effectiveness in preventing pregnancy. A literature review was completed for reports including women treated with the Yuzpe using a MEDLINE search for articles published since 1970 and by reviewing the secondary reference lists of these manuscripts. Expected pregnancy rates for each study population were calculated using published conception rate estimates. Seven published studies provided adequate data to assess accurately efficacy of the Yuzpe regimen in preventing pregnancy after unprotected intercourse. Of 2871 women treated, 54 (1.9%, 95% confidence intervals (CI) 1.4-2.4) became pregnant. By calculating the expected pregnancy rates using two different methodologies, the Yuzpe regimen decreased the observed number of pregnancies by 70.0% (95% CI 63.3-76.7) and 77.2% (95% CI 71.5-82.8). Emergency contraception with the Yuzpe regimen is an effective form of contraception to prevent unwanted pregnancy after unprotected intercourse.

Clinical Trials as Topic↗
PubMed1996

Methotrexate and misoprostol for early abortion: a multicenter trial. I. Safety and efficacy.

A prospective trial was conducted including 300 pregnant women seeking elective abortion to evaluate the safety and efficacy of methotrexate and misoprostol for abortion at < or = 56 days gestation. Subjects received methotrexate 50 mg/ m2 intramuscularly followed 7 days later by misoprostol 800 micrograms vaginally. The misoprostol dose was repeated the next day if the abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), duration of vaginal bleeding, and side effects. Complete abortion occurred in 263/ 300 (87.7%, 95% CI 83.4, 91.2%) patients. The complete abortion rate was higher for early gestations: 183/202 (90.6%, 95% CI 85.7, 94.2%) at < or = 49 days gestation, and 80/98 (81.6%, 95% CI 72.5, 88.7%) from 50-56 days gestation (p = 0.038). Abortion occurred in the 24 hours following the initial or repeat misoprostol dose (immediate success) in 65.0%; the remaining 22.7% of women who aborted did so after a delay of 23.6 +/- 9.1 (mean +/- standard deviation) days. Vaginal bleeding lasted 14 +/- 7 days and 11 +/- 9 days in immediate success and delayed success patients, respectively. Overall, 69.7%, 87.7%, and 91.7% of patients had passed the pregnancy by 14, 28, and 35 days, respectively, after receiving methotrexate. Methotrexate and misoprostol side effects were minimal. This treatment regimen offers an alternative to surgical abortion or the use of antiprogestins and prostaglandin for medical abortion.

Abortifacient Agents, Nonsteroidal↗