Biomedical subjects

M D Creinin

Publications and source records attributed to M D Creinin.

At least 19 recordsLinked to original sources

PubMed2004

Endometrial thickness after misoprostol use for early pregnancy failure.

OBJECTIVES: To assess if there was any potential relationship between endometrial thickness and final treatment outcome in women successfully treated with misoprostol for a first trimester anembryonic gestation, embryonic demise or fetal demise. METHODS: Eighty women were treated with up to two doses of misoprostol 800 microg vaginally for early pregnancy failure. Subjects were scheduled to return 2 (range 1-4), 7 (range 5-9) and 14 (range 12-17) days after treatment. Transvaginal ultrasonography was performed at each follow-up visit. RESULTS: The median endometrial thickness at each of the follow-up visits for women who had expelled the gestational sac was 14 mm, 10 mm, and 7 mm, respectively. The endometrial thickness at the first follow-up visit exceeded 15 mm in 20 subjects (36%) and 30 mm in four subjects (7%). Only three women had a suction aspiration for bleeding after documented expulsion. The endometrial thickness for these women was 11, 13, and 14 mm at the first follow-up visit. CONCLUSIONS: There is no obvious relationship between increasing endometrial thickness and the need for surgical intervention in women treated with misoprostol for early pregnancy failure.

Abortifacient Agents, Nonsteroidal↗

PubMed2001

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

We performed a pilot study to examine the clinical efficacy of mifepristone 200 mg followed on the same day by misoprostol 800 microg 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 microg vaginally, effects abortion at rates comparable to regimens using the standard time interval of 48 h between medications.

Abortifacient Agents, Nonsteroidal↗

PubMed2001

Mifepristone 100 mg in abortion regimens.

OBJECTIVE: To examine the clinical efficacy of mifepristone 100 mg followed 2 days later by misoprostol 400 microg orally or 800 microg vaginally in women at up to 49 days' gestation. METHODS: Eighty participants received mifepristone 100 mg and then were randomized to misoprostol, administered 48 hours later, at a dose of 400 microg orally (group 1) or 800 microg vaginally (group 2). Women returned for follow-up evaluations 24 +/- 1 hour after using the misoprostol and then 2-3 weeks later. If abortion still had not occurred and the pregnancy was nonviable, the subject returned again after an additional 3 weeks. RESULTS: Twenty-four hours after receiving misoprostol, 34 (85%; 95% confidence interval [CI] 71%, 94%) of the 40 women in group 1 and 38 (95%; 95% CI 85%, 99%) of the 40 women in group 2 had complete abortions. Overall, complete abortion without surgical intervention occurred in 34 women in group 1 (85%; 95% CI 71%, 94%) and 40 women in group 2 (100%; 95% CI 91%, 100%; P =.03). Four women in group 1 required suction aspiration for continuing pregnancy at the second follow-up, compared with none in group 2 (P =.12). Side effects occurred with similar frequency in both treatment groups. CONCLUSION: Low-dose mifepristone (100 mg) combined with vaginal misoprostol 800 microg may be an effective alternative to regimens using 200 or 600 mg of mifepristone with misoprostol.

Abortifacient Agents, Nonsteroidal↗

PubMed2001

Toxic shock syndrome after laminaria insertion.

BACKGROUND: Laminaria tents used to facilitate surgical abortion are rarely associated with significant infectious morbidity. CASE: A parous woman in midpregnancy had laminaria placed in her cervix followed by a second set after 24 hours. Eight hours later, she presented with dyspnea, hives, fever, tachycardia, and hypotension. Antibiotic treatment was initiated and a dilation and evacuation procedure was performed. Amniotic membrane cultures showed a heavy growth of Staphylococcus aureus with staphylococcal enterotoxin C expression, compatible with toxic shock syndrome. CONCLUSION: Laminaria cervical dilation might be associated with toxic shock syndrome.

Abortion, Induced↗

PubMed2001

The risks of oral contraceptive pills.

Oral contraceptive pills have been associated with increased risk for myocardial infarction, stroke, and venous thromboembolism. Studies have been published recently that suggest that these risks are minimal in appropriately chosen low-risk women. Stroke is a very uncommon event in childbearing women, occurring in approximately 11 per 100,000 women over 1 year. Thus, even a doubling of this risk with oral contraceptive pills would have minimal effect on attributable risk. The estimated risk of myocardial infarction associated with oral contraceptive pill use in nonsmokers is 3 per million women over 1 year. The estimated risk of venous thromboembolism attributable to oral contraceptive pills is less than 3 per 10,000 women per year. Additionally, the literature suggests that there may be an increased risk of breast cancer associated with long-term oral contraceptive pill use in women under the age of 35. However, because the incidence of breast cancer is so low in this population, the attributable risk of breast cancer from birth control pill use is small.

Breast Neoplasms↗

PubMed2001

Accuracy of serum beta-human chorionic gonadotropin cutoff values at 42 and 49 days' gestation.

OBJECTIVE: The accuracy of serum beta-human chorionic gonadotropin levels as cutoff values for estimating gestational age was studied. MATERIAL AND METHODS: A database was created using information from previously performed research studies, which allowed entry of women both less than and greater than 49 days' gestation, involving medical abortion. Serum beta-human chorionic gonadotropin determinations and vaginal ultrasonography were performed in all studies before treatment. A total of 574 women had data available for analysis. A receiver operating characteristic curve was created to evaluate the predictive value of potential beta-human chorionic gonadotropin cutoff values for 42 and 49 days' gestation. RESULTS: Appropriate serum beta-human chorionic gonadotropin cutoff values for 42 and 49 days' gestation were 23,745 mIU/mL (sensitivity, 96%; specificity, 91%; positive predictive value, 68%; negative predictive value, 99%) and 71,160 mIU/mL (sensitivity, 95%; specificity, 62%; positive predictive value, 76%; negative predictive value, 91%), respectively. Under 42 days' gestation, the serum beta-human chorionic gonadotropin-time relationship appears to be linear, with a greater diversity of individual values after 42 days. CONCLUSION: Serum beta-human chorionic gonadotropin values can be used with reasonable accuracy to screen for a gestational age up to 49 days' gestation.

Abortion, Therapeutic↗

PubMed2001

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 modem 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.

Abortifacient Agents, Nonsteroidal↗

PubMed2001

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

OBJECTIVE: To examine the clinical efficacy of mifepristone 600 mg followed on the same day or two days later by misoprostol 400 microg orally in women undergoing medical termination of pregnancy whose pregnancies have a gestational age up to 49 days. DESIGN: Prospective, randomised trial. SETTING: Clinical research office. PARTICIPANTS: Eighty-six women, requesting elective termination of a pregnancy which has a gestational age of < or = 49 days. METHODS: After administration of mifepristone 600 mg, participants were randomised to take misoprostol six to eight hours later (Group 1) or 48 hours later (Group 2). Women returned for a follow up evaluation 24 +/- 1 hours after taking the misoprostol. Participants in Group 1 who had not aborted received a second dose of misoprostol to take 48 hours after the mifepristone. All women returned approximately two weeks after receiving mifepristone. If termination of pregnancy had still not occurred and the pregnancy was non-viable, the woman returned again in three weeks. MAIN OUTCOME MEASURES: Rate of complete abortion 24 hours after administration of misoprostol. RESULTS: At 24 hours after receiving misoprostol, 21/42 (50%, 95% CI 35%, 65%) women in Group I and 40/44 (91%, 95% CI 82%, 99%) women in Group 2 had complete abortions. By follow up two weeks later after the administration of mifepristone, 40/42 (95%, 95% CI 89%, 100%) women in Group 1 and 43/44 (98%, 95% CI 93%, 99%) women in Group 2 were known to have complete abortions. Nausea, vomiting or diarrhoea in women using the standard regimen (Group 2) occurred in 68%, 36%, and 20%, respectively. CONCLUSIONS: After treatment with mifepristone 600 mg, administration of misoprostol 400 microg orally on the same day is not as effective at causing abortion within the first 24 hours compared with the standard time interval of 48 hours between medications.

Abortifacient Agents, Nonsteroidal↗

PubMed2000

Randomized comparison of efficacy, acceptability and cost of medical versus surgical abortion.

This randomized trial was performed to examine the clinical efficacy of, patient acceptance of, and provider resources needed for medical and surgical abortion in women with pregnancies up to 49 days' gestation. Women with no pre-treatment preference for method of abortion were randomized to medical abortion with methotrexate and misoprostol (group 1) or surgical abortion under local anesthesia using manual vacuum aspiration (group 2). Women in group 1 received methotrexate 50 mg orally followed 5 to 6 days later by misoprostol 800 microg vaginally; the misoprostol dose was repeated if the abortion did not occur. All subjects returned for a follow-up evaluation 7 and 14 days after the methotrexate or 14 days after the vacuum aspiration. The time spent by clinical staff for all interactions with participants was prospectively recorded. Enrollment of 50 subjects took 24 months; 25 women were randomized to each group. The complete abortion rates by study day 15 were 83% (95% CI 68, 98%) and 96% (95% CI 88, 100%) for groups 1 and 2, respectively. Of the women randomized to a surgical abortion, 92% (95% CI 81, 100%) stated they would choose a surgical for a next abortion, whereas only 63% (95% CI 43, 82%) of women randomized to a medical abortion would choose that option in the future. Overall, surgical abortion requires 0 to 10% more personnel cost than medical abortion using methotrexate and misoprostol. In women who did not have a strong preference between medical and surgical abortion, the side effect profile and patient acceptability was significantly better for surgical abortion compared to medical abortion.

Abortifacient Agents↗

PubMed2000

The efficacy of medical abortion: a meta-analysis.

Multiple clinical studies demonstrate the efficacy of medical abortion with mifepristone or methotrexate followed by a prostaglandin analogue. However, assessing predictors of success, including regimen, is difficult because of regimen variability and a lack of direct comparisons. This meta-analysis estimates rates of primary clinical outcomes of medical abortion (successful abortion, incomplete abortion, and viable pregnancy) and compares them by regimen and gestational age. We identified 54 studies published from 1991 to 1998 using mifepristone with misoprostol (18), mifepristone with other prostaglandin analogues (23), and methotrexate with misoprostol (13). Data abstracted from studies included regimen details and clinical outcomes by gestational age. We found that efficacy decreases with increasing gestational age (p<0.001), and differences by regimen are not statistically significant except at gestational age > or =57 days. For gestations < or =49 days, mean rates of complete abortion were 94-96%, incomplete abortion 2-4%, and ongoing (viable) pregnancy 1-3%. For gestations of 50-56 days, the mean rate of complete abortion was 91% (same for all regimens), incomplete abortion 5-8%, and ongoing pregnancy 3-5%. For > or =57 days, success was lower for mifepristone/misoprostol (85%, 95% confidence interval 78-91%) than for mifepristone/other prostaglandin analogues 95% (CI 91-98%, p = 0.006). For mifepristone/misoprostol, using > or =2 prostaglandin analogue doses seems to be better than a single dose for certain outcomes and gestational ages. We conclude that both mifepristone and methotrexate, when administered with misoprostol, have high levels of success at < or =49 days gestation but may have lower efficacy at longer gestation.

Abortifacient Agents↗

PubMed2000

Meclizine for prevention of nausea associated with use of emergency contraceptive pills: a randomized trial.

OBJECTIVE: We conducted a randomized trial to determine whether pretreatment with meclizine reduces the incidence of nausea and vomiting associated with the Yuzpe regimen of emergency contraception. METHODS: We randomly assigned 343 women aged 18-45 years who were not at risk for pregnancy to pretreatment with 50 mg of meclizine, placebo, or no drug 1 hour before the first of two doses of emergency contraceptive pills. We asked participants to complete three questionnaires over the following 48 hours. RESULTS: The incidence of nausea was 47% in the group pretreated with meclizine and 64% in the other two groups (relative risk adjusted for center 0.7, 95% confidence intervals 0.6, 0.9 for comparisons of meclizine with both placebo and no drug). The severity of nausea and the incidence of vomiting were also significantly lower in the meclizine pretreatment group than in the other two groups. Drowsiness was reported by about twice as many women in the meclizine pretreatment group (31%) than in the other two groups (13% in the placebo group, 16% in the no-pretreatment group; P < .01 for both comparisons). CONCLUSION: Meclizine is effective for preventing nausea and vomiting associated with the Yuzpe regimen of emergency contraceptive pills. Women using this drug should be cautioned to anticipate drowsiness.

Adolescent↗

PubMed2000

Management of side effects and complications in medical abortion.

Side effects are an expected part of medical abortion; some, such as pain and bleeding, result from the abortion process itself and are generally managed with orally administered analgesics and counseling. True medication side effects most commonly include nausea, vomiting, diarrhea, and warmth or chills. Complications of medical abortion usually represent an extreme or severe side effect. Large series have reported transfusion rates of <1%. Because of the infrequency of uterine instrumentation, postabortal endometritis appears to be rare with medical abortion. As with early surgical abortion, the clinician must remain aware of the possibility for ectopic pregnancy. Overall approximately 2% to 10% of patients will require surgical intervention for control of bleeding, resolution of incomplete expulsion, or termination of a continuing pregnancy. Understanding the types of side effects and complications that can occur will enable the clinician to counsel patients properly as well as to understand when medical intervention is necessary during the medical abortion process.

Abortifacient Agents↗

PubMed2000

Medical abortion regimens: historical context and overview.

Medical abortion offers an important alternative to surgical abortion for women with early pregnancies who wish to avoid a surgical procedure. More than 3 million women worldwide have had medical abortions in the past decade alone. The best-studied regimens include mifepristone orally followed 36 to 48 hours later by a prostaglandin analog administered either orally or intravaginally. Because of political and social restrictions related to mifepristone, however, researchers have investigated alternative regimens, most notably methotrexate and misoprostol. Mifepristone regimens are approximately 95% effective for abortion at </=49 days' gestation. Efficacy between 50 and 63 days' gestation varies according to the type and route of administration of the prostaglandin analog. Complete abortion rates among these later gestations are clinically acceptable when mifepristone is followed by intravaginally administered misoprostol or gemeprost. This report reviews the development, efficacy, and side effects of mifepristone regimens.

Abortifacient Agents↗

PubMed2000

Alternatives to mifepristone regimens for medical abortion.

Alternatives to regimens with mifepristone and a prostaglandin analog for medical abortion emerged because of the need for accessible, effective, and safe options in areas of the world where mifepristone was unavailable. Studies of oral or intramuscular methotrexate combined with misoprostol have demonstrated complete abortion rates in the same range as mifepristone regimens at </=49 days' gestation. The overall abortion process with methotrexate and misoprostol takes longer, however, with 20% to 30% of women requiring from 1 to 5 weeks for the abortion to occur. Multiple investigators have confirmed the safety, efficacy, and acceptability of various methotrexate and misoprostol regimens. Recent reports suggest that misoprostol alone may have similar efficacy, but with significantly higher rates of side effects. Randomized trials are needed to directly compare the clinical efficacies and acceptabilities of available medical abortion regimens.

Abortifacient Agents, Nonsteroidal↗

PubMed2000

Medical abortion alternatives to mifepristone.

Social and political constraints have prohibited the use of mifepristone in most countries. As a result, researchers, clinicians, and women throughout the world have pushed for the development of alternative medical abortion regimens. Methotrexate (both oral and intramuscular) combined with misoprostol has been under investigation since 1993, with complete abortion rates similar to mifepristone regimens for pregnancies up to 49 days' gestation. Thousands of women have had safe medical abortions in their own homes using these medications. The overall abortion process using methotrexate and misoprostol takes longer, however, with 20% to 30% of women waiting up to five weeks for the abortion to occur. More recently, misoprostol-only regimens have been proposed for medical termination of pregnancy. The efficacy of these misoprostol regimens has been reported in the same range as those combining mifepristone or methotrexate with misoprostol, although other investigators have been unable to confirm these results. Additionally, a few small studies have tested tamoxifen combined with misoprostol, with mixed results. Continued research is necessary to ensure that reported efficacy rates for all proven medical abortion regimens are true for various populations of women.

Abortifacient Agents, Nonsteroidal↗

PubMed1999

Success rates and estimation of gestational age for medical abortion vary with transvaginal ultrasonographic criteria.

OBJECTIVE: Our purpose was to evaluate differences in gestational age and success rates for medical abortion patients obtained by using several nomograms for mean sac diameter and embryonic pole. STUDY DESIGN: A retrospective review of 1011 patients was performed; the data were from 8 published studies and private patients of the primary author (M.D.C.) who received methotrexate and misoprostol for abortion. The ultrasonographic findings at baseline examination were used to estimate gestational age according to criteria established by Hellman et al and Rossavik et al for mean sac diameter and Robinson, Hadlock et al, and Goldstein and Wolfson for the embryonic pole. The assigned gestational ages of the study population were then compared, and the success rates of treatment at various gestational ages were calculated for each of the dating criteria. RESULTS: Outcomes on the basis of gestational age for those patients who had only a gestational sac were similar regardless of which gestational age criteria were used. The final assessment of gestational age by embryonic pole according to the criteria of Goldstein and Wolfson was significantly different from the others. CONCLUSIONS: Medical abortion outcomes will vary depending on which criteria are used for establishing gestational age by both mean sac diameter and embryonic pole.

Abortifacient Agents, Nonsteroidal↗

PubMed1999

Use of various ultrasonographic criteria to evaluate the efficacy of mifepristone and misoprostol for medical abortion.

OBJECTIVE: This study was undertaken to determine whether applying modern formulas for mean sac diameter and crown-rump length to data from the recently published US mifepristone-misoprostol abortion trial would result in differences in assigned gestational ages and a higher rate of complete abortion. STUDY DESIGN: Data from the US mifepristone-misoprostol trial were reanalyzed. The ultrasonographic findings at baseline examination of the 2121 participants were used to estimate gestational age according to criteria established by Rossavik et al for mean sac diameter and by Robinson and Fleming, Hadlock et al, and Goldstein and Wolfson for embryonic pole. The gestational ages as assigned by the different criteria were then compared and the treatment outcomes at various gestational ages were calculated for each of the dating criteria. These findings were compared with those reported in the original study. RESULTS: Fourteen percent of study subjects were assigned to the incorrect gestational age group according to the criteria used for the original report. Still, outcomes according to gestational age group were similar regardless of which ultrasonographic gestational age criteria were used and were comparable to those calculated in the original report. Overall efficacy for subjects at </=42 days' gestation was 95% to 96%, compared with 91% for subjects at between 43 and 49 days' gestation, when the various criteria were used. CONCLUSIONS: The results from the United States mifepristone-misoprostol abortion study were not altered by applying modern and appropriate ultrasonographic dating formulas. The rate of complete abortion was highest among subjects at </=42 days' gestation.

Abortifacient Agents↗

PubMed1999

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.

Abortifacient Agents, Nonsteroidal↗