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Biomedical subjects

Mitchell D Creinin

Publications and source records attributed to Mitchell D Creinin.

At least 19 recordsLinked to original sources
PubMed2007

Race, insurance status, and tubal sterilization.

OBJECTIVE: To examine the independent effects of race or ethnicity and insurance status on use of tubal sterilization rates. METHODS: This study used cross-sectional data collected by the 2002 National Survey of Family Growth. The survey is designed to represent women and men aged 15-44 years in the household population of the United States. Our main outcome measure was tubal sterilization at any time before interview. A multivariable logistic regression model was used to estimate the effects of race or ethnicity and insurance status on rates of tubal sterilization after adjusting for important confounders. RESULTS: The sample consisted of 7,643 women: 66% were white, 15% were Hispanic, and 14% were African American; 68% had private insurance and 32% had public or no insurance. After adjusting for age, insurance status, parity, income, education, marital status, and religion, African-American women were more likely than white women to undergo tubal sterilization (adjusted odds ratio 1.43, 95% confidence interval 1.08-1.88). After adjusting for age, race or ethnicity, parity, income, education, marital status, and religion, women with public or no insurance were more likely to undergo sterilization compared with women with private insurance (adjusted odds ratio 1.38, 95% confidence interval 1.09-1.74). CONCLUSION: African-American women and women with no or public insurance were more likely to have undergone tubal sterilization compared with white women and women with private insurance, respectively. Additional research to identify factors that influence women's decision to undergo sterilization is warranted. LEVEL OF EVIDENCE: II.

Adolescent↗
PubMed2006

Psychiatric outcomes following medical and surgical abortion.

BACKGROUND: Hypercortisolaemia is associated with certain depressive disorders. Mifepristone has possible antidepressant properties related to its anti-glucocorticoid activity. To explore the possible mood effects of mifepristone, we examined the mood outcomes after surgical and medical (mifepristone-misoprostol) abortion. The objectives were to determine post-abortion depression risk, evaluate risk factors for post-abortion depression and to explore the relationship between cortisol and depression. METHODS: We enrolled 47 surgical and 31 medical abortion patients. Women were assessed pre-abortion and 1 month post-abortion with the Edinburgh Postnatal Depression Scale (EPDS) and salivary cortisol levels. RESULTS: Pre-abortion, 36% (17/47) of surgical and 35% (11/31) of medical patients had high depression risk (EPDS > or = 10; (chi(2) = 0.31, df = 1, P = 0.58). At follow-up, 17% (7/42) of surgical and 21% (5/24) of medical patients had an EPDS > or = 10 (chi(2) = 0.18, df = 1, P = 0.67). The decline post-abortion in the women with EPDS > or = 10 was significant (P = 0.01). Women with past psychiatric history (Fisher's exact P = 0.05) or anxiety disorders (Fisher's exact P = 0.005) had elevated risk for post-abortion depression. Change in cortisol levels was not correlated with change in EPDS (r = 0.10, P = 0.28). CONCLUSIONS: Most patients experienced post-abortion mood improvement. Mifepristone did not offer additional antidepressant effects. The lack of correlation between cortisol and depression could represent hypersuppression of the hypothalamic-pituitary-adrenal (HPA) axis or insufficient mifepristone dose to alter HPA axis activity.

Abortifacient Agents, Steroidal↗
PubMed2006

Mifepristone and misoprostol for the treatment of early pregnancy failure: a pilot clinical trial.

BACKGROUND: In an attempt to improve efficacy for women who desire medical management of early pregnancy failure (EPF), we studied the efficacy and acceptability of mifepristone 200 mg, orally (po), followed 24 h later by misoprostol 800 microg, vaginally (pv), for the treatment of EPF. METHODS: We enrolled 30 women with EPF in this pilot clinical trial. All women used misoprostol 800 microg, pv, 24 h after ingesting 200 mg mifepristone. Follow-up evaluations with transvaginal ultrasonography occurred at 24 h and 1 week after treatment. Participants were offered a repeat dose of misoprostol if the pregnancy had not been expelled at the first follow-up. RESULTS: The expulsion rate with one dose of misoprostol was 90% (95% CI=79-100%). The overall success rate of the treatment was 93% (95% CI=84-100%). CONCLUSION: This regimen of mifepristone followed by vaginal misoprostol appears to be an efficacious and acceptable treatment for EPF and may have improved results over a single dose of misoprostol alone.

Abortifacient Agents↗
PubMed2006

Fourteen-day safety and acceptability study of 6% cellulose sulfate gel: a randomized double-blind Phase I safety study.

BACKGROUND: Topical microbicides against the human immunodeficiency virus (HIV) 1 that are nonirritating to the female genital epithelium are urgently needed to slow the heterosexual spread of HIV infection. Products that are also effective contraceptives provide additional benefits. Cellulose sulfate (CS) is a noncytotoxic antifertility agent that exhibits in vitro antimicrobial activity against sexually transmitted pathogens, including HIV. METHODS: We performed a multicenter, Phase I, placebo-controlled, randomized study to evaluate the genital toxicity of CS. Two cohorts of healthy women used 3.5 ml of 6% CS gel or 3.5 ml of K-Y Jelly, vaginally, bid, for 14 days. The first cohort was sexually abstinent, and the second cohort was sexually active. RESULTS: CS was associated with only a slightly higher odds ratio (OR) of symptoms of minor urogenital irritation compared to the inactive lubricant K-Y Jelly (OR=2.02, 95% confidence interval=0.90-4.53). In addition, there were minor shifts in some genital flora, but there was no evidence of greater inflammation as evidenced by few colposcopic findings, decreased influx of polymorphonuclear cells and minimal changes in proinflammatory cytokines. Moreover, both products appeared acceptable to most women. Product leakage was identified as more of a problem in sexually abstinent women, but less so in women using the product for sexual intercourse, as would be the case in actual practice. CONCLUSION: CS was safe for twice-daily use for 14 days. CS is appropriate for future studies in effectiveness trials.

Adolescent↗
PubMed2006

Training and attitudes about contraceptive management across primary care specialties: a survey of graduating residents.

PURPOSE: Little is known about how physicians' attitudes and knowledge of contraception could impact the unintended pregnancy rate in the United States. The objective of this study was to analyze survey data from physicians in primary care training programs in Pittsburgh, PA. METHODS: A cross-sectional survey was administered to primary care medical residents in Allegheny County, PA. Descriptive statistics were used to illustrate training, attitudes and knowledge regarding contraceptive management. A multivariable analysis was performed to elucidate associations between training, attitudes and behavior. RESULTS: Of 143 residents surveyed, 74 (52%) responded. The mean score on contraceptive knowledge assessment was 54%. Obstetrics/gynecology residents performed consistently better on the knowledge index (p<.01). Among nonobstetrics/gynecology residents, formal training in contraception, female gender, ability to insert an intrauterine device and not being a family practitioner were independently associated with improved knowledge (p<.05). CONCLUSIONS: Most of the responding graduating residents view contraception as an important component of primary care. However, young physicians have a contraceptive knowledge base that is inconsistent across primary care specialties. Improvement in this area might improve the unintended pregnancy rate in the United States.

Adult↗
PubMed2006

Effects of long-term use of nonoxynol-9 on vaginal flora.

OBJECTIVE: Products containing nonoxynol-9 have been used as spermicidal contraceptives for many years, but limited data have been published describing the long-term effects of nonoxynol-9 use on the vaginal microbial ecosystem. This longitudinal study was conducted to examine the effects of nonoxynol-9 on the vaginal ecology. METHODS: Vaginal swabs were obtained from 235 women enrolled in a randomized clinical trial before initiation of use of 1 of 5 different formulations of nonoxynol-9 for contraception, and up to 3 more samples were gathered over 7 months of use. The swab samples were evaluated in a single laboratory. The prevalence of several constituents of the normal vaginal flora was evaluated. The associations between nonoxynol-9 dosage, formulation, average product use per week, and number of sex acts per week were calculated. RESULTS: The changes in prevalence of vaginal microbes after nonoxynol-9 use were minimal for each of the different nonoxynol-9 formulations. However, when both nonoxynol-9 concentration and number of product uses are taken into account, nonoxynol-9 did have dose-dependant effects on the increased prevalence of anaerobic gram-negative rods (odds ratio [OR] 2.4, 95% confidence interval [CI] 1.1-5.3), H2O2-negative lactobacilli (OR 2.0, 95% CI 1.0-4.1), and bacterial vaginosis (OR 2.3, 95% CI 1.1-4.7). CONCLUSION: This study demonstrated that most nonoxynol-9 users experienced minimal disruptions in their vaginal ecology. There were no differences between the different formulations evaluated with respect to changes in vaginal microflora. However, independent of the nonoxynol-9 formulation, there was a dose-dependent effect with increased exposure to nonoxynol-9 on the risk of bacterial vaginosis and its associated flora. LEVEL OF EVIDENCE: II-2.

Administration, Intravaginal↗
PubMed2006

Factors related to successful misoprostol treatment for early pregnancy failure.

OBJECTIVE: To identify potential predictors for treatment success in medical management with misoprostol for early pregnancy failure. METHODS: We conducted a planned secondary analysis of data from a multicenter trial that compared medical and surgical management of early pregnancy failure. Medical management consisted of misoprostol 800 mug vaginally on study day 1, with a repeat dose if indicated on day 3. Women returned on days 3 and 15, and a telephone interview was conducted on day 30. Failure was defined as suction aspiration for any reason within 30 days. Demographic, historical, and outcome variables were included in univariable analyses of success. Multivariable analyses were conducted using clinical site, gestational age, and variables for which the univariable analysis resulted in a P < .1 to determine predictors of overall treatment success and first-dose success. RESULTS: Of the 491 women who received misoprostol, 485 met the criteria for this secondary analysis. Lower abdominal pain or vaginal bleeding within the last 24 hours, Rh-negative blood type, and nulliparity were predictive of overall success. However, only vaginal bleeding within the last 24 hours and parity of 0 or 1 were predictive of first-dose success. Overall success exceeds 92% in women who have localized abdominal pain within the last 24 hours, Rh-negative blood type, or the combination of vaginal bleeding in the past 24 hours and nulliparity. CONCLUSION: Misoprostol treatment for early pregnancy failure is highly successful in select women, primarily those with active bleeding and nulliparity. Clinicians and patients should be aware of these differences when considering misoprostol treatment. LEVEL OF EVIDENCE: II-2.

Abortifacient Agents, Nonsteroidal↗
PubMed2006

Progesterone receptor modulator for emergency contraception: a randomized controlled trial.

OBJECTIVE: Compare the efficacy and adverse effects of CDB-2914, a new progesterone receptor modulator, to levonorgestrel for emergency contraception. METHODS: We performed a randomized, double-blinded noninferiority trial, enrolling healthy women seeking emergency contraception within 72 hours of unprotected intercourse. Participants were randomly assigned to receive a single dose of 50 mg of CDB-2914, plus a placebo 12 hours later or two doses of 0.75 mg of levonorgestrel taken 12 hours apart. Follow-up was scheduled 5 to 7 days after the expected onset of the next menstrual period. Posttreatment pregnancy was established by a positive urine test at follow-up and confirmed by quantitative serum beta-hCG. Daily diaries were used from the time of emergency contraception use until next menses to record adverse effects and sexual activity. RESULTS: Product efficacy was evaluable in 775 of CDB-2914 users and 774 of levonorgestrel users. Pregnancies occurred in 7 (0.9%, 95% confidence interval 0.2-1.6%) and 13 (1.7%, 95% confidence interval 0.8-2.6%) women, respectively. Based on the estimated cycle day of unprotected intercourse, 85% and 69% of anticipated pregnancies, respectively, were averted. Nausea was reported by a somewhat greater percentage of CDB-2914 than levonorgestrel users (29% compared with 24%, P=.03), but the distribution of other adverse effects was similar in both groups. Women in both groups experienced considerable variation in menstrual cycle length as compared with their reported individual normal cycle lengths. CONCLUSION: CDB-2914 is at least as effective as levonorgestrel in preventing pregnancies after unprotected intercourse and has a similar side effect profile. LEVEL OF EVIDENCE: I.

Adolescent↗
PubMed2005

FemCap with removal strap: ease of removal, safety and acceptability.

OBJECTIVES: FemCap is a silicone-rubber barrier contraceptive approved for marketing in the United States. To address reported problems with removal and dislodgment, the device's developer added a strap to the device and increased the height of the brim. This trial assessed whether the new design reduced removal difficulties and had any effects on dislodgment, genital pain/discomfort, safety, and acceptability. METHODS: Women used the strapped device for 8 weeks with follow-up visits at 2 and 8 weeks. Outcome measures were obtained through diary cards, questionnaires, and naked eye examination. Data from these 120 women were compared with data from 419 women who used the unstrapped FemCap in a previous contraceptive effectiveness study. RESULTS: The strapped device was not significantly easier for users to remove than the unstrapped device. Similar odds of dislodgment and cervical/vaginal irritation were seen with the two devices. Both female and male participants were significantly more likely to report pain/discomfort with use of the strapped device. Female users of the strapped device were significantly more likely to say they disliked their device. In six weeks, two pregnancies were observed, but pregnancy was not an endpoint in the study and no conclusions should be drawn regarding pregnancy rates. CONCLUSIONS: The modifications to the FemCap did not significantly improve the ease of device removal and appears to have resulted in significantly more female and male partner pain/discomfort and decreased acceptability, compared with the unstrapped device.

Contraceptive Devices, Female↗
PubMed2005

A comparison of medical management with misoprostol and surgical management for early pregnancy failure.

BACKGROUND: Misoprostol is increasingly used to treat women who have a failed pregnancy in the first trimester. We assessed the efficacy, safety, and acceptability of this treatment in a large, randomized trial. METHODS: A total of 652 women with a first-trimester pregnancy failure (anembryonic gestation, embryonic or fetal death, or incomplete or inevitable spontaneous abortion) were randomly assigned to receive 800 microg of misoprostol vaginally or to undergo vacuum aspiration (standard of care) in a 3:1 ratio. The misoprostol group received treatment on day 1, a second dose on day 3 if expulsion was incomplete, and vacuum aspiration on day 8 if expulsion was still incomplete. Surgical treatment (for the misoprostol group) or repeated aspiration (for the vacuum-aspiration group) within 30 days after the initial treatment constituted treatment failure. RESULTS: Of the 491 women assigned to receive misoprostol, 71 percent had complete expulsion by day 3 and 84 percent by day 8 (95 percent confidence interval, 81 to 87 percent). Treatment failed in 16 percent of the misoprostol group and 3 percent of the surgical group (absolute difference, 12 percent; 95 percent confidence interval, 9 to 16 percent) by day 30. Hemorrhage or endometritis requiring hospitalization was rare (1 percent or less in each group), with no significant differences between the groups. In the misoprostol group, 78 percent of the women stated that they would use misoprostol again if the need arose and 83 percent stated that they would recommend it to others. CONCLUSIONS: Treatment of early pregnancy failure with 800 microg of misoprostol vaginally is a safe and acceptable approach, with a success rate of approximately 84 percent.

Abortifacient Agents, Nonsteroidal↗
PubMed2005

Same-day initiation of the transdermal hormonal delivery system (contraceptive patch) versus traditional initiation methods.

INTRODUCTION: Published comparisons of oral contraceptive pill (OCP) initiation methods demonstrate that OCP initiation at the office visit ("Quick Start") resulted in higher continuation rates into the second cycle. This trial was performed to investigate whether Quick Start with the contraceptive patch would provide similar results. MATERIALS AND METHODS: Sixty women were randomized to initiate use of the contraceptive patch using Quick Start (Group 1, n=30) or on the first day of their next menses (Group 2, n=30). Telephone contact at 6 weeks occurred to ensure that the second cycle had been initiated. A single follow-up visit was scheduled after completion of the third patch cycle. RESULTS: Continuation rates for Groups 1 and 2 were 97% and 93% (p=1.0), respectively, into the second cycle, and 93% and 90%, respectively, into the third cycle (p=1.0). Only approximately half of the subjects planned to continue using the patch after the study. CONCLUSION: Quick Start for the contraceptive patch did not improve continuation rates into the second or third cycle.

Administration, Cutaneous↗
PubMed2005

The true cost differential between mifepristone and misoprostol and misoprostol-alone regimens for medical abortion.

Our objective was to evaluate relative differences in direct and total (direct and indirect) costs for medical abortion regimens using mifepristone and misoprostol or misoprostol alone. We created formulas to evaluate relative differences in costs in the United States, Chennai (Madras), India, and a hypothetical developing country based on published protocols and efficacy data. Follow-up visits and suction aspiration procedures in the United States were evaluated over a range of costs. American indirect costs were estimated using earning data. Indirect costs in India and the hypothetical developing country were based on mifepristone cost differences between the United States and India. Although mifepristone costs US dollar 83.33 for every 200-mg tablet in the United States, the actual excess cost of using a mifepristone regimen, as compared with a misoprostol-alone regimen, is only US dollar 22 to US dollar 32. The actual cost of a mifepristone regimen is lower than that of a misoprostol-alone regimen in India. In a hypothetical developing country, a mifepristone regimen is likely to be less expensive than regimens using misoprostol alone. Because of the higher efficacy of medical abortion regimens using mifepristone and misoprostol and the need for fewer follow-up evaluations, such regimens are less expensive or only minimally more expensive than those using misoprostol alone.

Abortifacient Agents, Nonsteroidal↗
PubMed2005

A pilot study of mifepristone and misoprostol administered at the same time for abortion up to 49 days gestation.

HYPOTHESIS: Simultaneous administration of mifepristone and misoprostol for medical abortion in women up to 49 days gestation will result in complete abortion in 90% of women within 24 h of treatment. MATERIALS AND METHODS: Forty women with pregnancies up to 49 days gestation inserted 800 mug vaginal misoprostol in our office immediately after taking mifepristone 200 mg orally. Follow-up visits, which included vaginal ultrasonography, occurred 24+/-1 h and 2 weeks after treatment. If a gestational sac was still present at the first follow-up visit, the misoprostol dose was repeated. Suction abortion was performed for a viable gestation at the second follow-up visit, presence of a nonviable gestation within 5 weeks of treatment and when clinically indicated. RESULTS: Expulsion occurred in 36/40 (90%, 95% CI 80-99) and 39/40 (98%, 95% CI 93-100) women by the first and second follow-up visits, respectively. One woman who had initially expelled the gestational sac after a single dose of misoprostol later required a suction curettage for an incomplete abortion. CONCLUSION: Simultaneous administration of mifepristone and vaginal misoprostol is a promising regimen for medical abortion up to 49 days gestation.

Abortifacient Agents, Nonsteroidal↗
PubMed2005

A pilot study of mifepristone and misoprostol administered at the same time for abortion in women with gestation from 50 to 63 days.

INTRODUCTION: In the interest of decreasing the amount of time it takes to achieve a medical abortion, we performed a pilot study to evaluate the simultaneous administration of mifepristone and vaginal misoprostol for women with gestation from 50 to 63 days. MATERIALS AND METHODS: Forty women were enrolled with undesired pregnancies from 50 to 56 days' gestation (group 1) and 40 from 57 to 63 days' gestation (group 2). All women used misoprostol 800 mug vaginally immediately after having swallowed the 200 mg mifepristone tablet. Follow-up evaluations with transvaginal ultrasonography occurred at 24 h and 2 weeks after treatment. RESULTS: The 24-h expulsion rates were 88% (95% CI, 77-98) and 83% (95% CI, 7-94) in groups 1 and 2, respectively. The complete abortion rates at 2 weeks were 93% (95% CI, 84-100) and 90% (95% CI, 81-99), respectively. DISCUSSION: Simultaneous administration of oral mifepristone and vaginal misoprostol provides 24-h expulsion rates in women with gestation from 50 to 63 days, comparable to those reported in the medical literature for standard treatment regimens. Further study of this regimen in a large randomized trial is warranted.

Abortifacient Agents, Nonsteroidal↗
PubMed2005

Acceptability of five nonoxynol-9 spermicides.

OBJECTIVE: To examine the acceptability of five nonoxynol-9 (N-9) spermicides. METHODS: We analyzed data from a randomized trial of five products, including three gels containing different amounts of N-9 per dose, a film and a suppository. In the trial, 1536 participants were asked to use the assigned spermicide for 7 months and to complete questionnaires 4 weeks after admission and at discontinuation. RESULTS: Overall, 43% of participants liked their spermicide "very much." This proportion was higher in the three gel groups than in the suppository and film groups. Difficulty with insertion, messiness and discontent with timing of insertion were common complaints in all groups. After adjustment for selected baseline factors, acceptability on the first questionnaire was not related to duration or consistency of subsequent spermicide use or to subsequent time to pregnancy. CONCLUSIONS: In this study, all five spermicides were considered acceptable by most users. Acceptability did not appear to influence spermicide use or pregnancy risk.

Adult↗
PubMed2005

Lea's Shield: colposcopic and microbiological testing during 8 weeks of use.

OBJECTIVES: The aims of this study were to assess the effects of Lea's Shield(R) plus nonoxynol-9 spermicide on signs and symptoms of female genital irritation and cervical and vaginal microflora during 8 weeks of use with intercourse and to analyze problems associated with the use of the device. METHODS: In this open-label, single-arm study, participants were evaluated by pelvic examination, colposcopy and vaginal and cervical cultures. RESULTS: About 13% of women (4/30) reported symptoms of irritation, and minor product-related colposcopic findings were seen in about one third (11/30). Although average colony counts for enterococcus, Escherichia coli and anaerobic gram-negative rods increased during product use, no clinical diagnoses of infection were made. Most users reported at least one problem using Lea's Shield. CONCLUSION: Lea's Shield, when used for 8 weeks during intercourse, is associated with evidence of genital irritation in a minority of users and with changes in vaginal microflora that do not appear to correlate with clinical infections.

Adolescent↗