How do we ensure 'high quality' clinical research?
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Biomedical Research↗
Biomedical subjects
Mitchell D Creinin
Publications and source records attributed to Mitchell D Creinin.
Body mass index, weight, and oral contraceptive failure risk.
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Body Mass Index↗
Participant characteristics associated with withdrawal from a large randomized trial of spermicide effectiveness.
BACKGROUND: In most recent large efficacy trials of barrier contraceptive methods, a high proportion of participants withdrew before the intended end of follow-up. The objective of this analysis was to explore characteristics of participants who failed to complete seven months of planned participation in a trial of spermicide efficacy. METHODS: Trial participants were expected to use the assigned spermicide for contraception for 7 months or until pregnancy occurred. In bivariable and multivariable analyses, we assessed the associations between failure to complete the trial and 17 pre-specified baseline characteristics. In addition, among women who participated for at least 6 weeks, we evaluated the relationships between failure to complete, various features of their first 6 weeks of experience with the spermicide, and characteristics of the study centers and population. RESULTS: Of the 1514 participants in this analysis, 635 (42%) failed to complete the study for reasons other than pregnancy. Women were significantly less likely to complete if they were younger or unmarried, had intercourse at least 8 times per month, or were enrolled at a university center or at a center that enrolled fewer than 4 participants per month. Noncompliance with study procedures in the first 6 weeks was also associated with subsequent early withdrawal, but dissatisfaction with the spermicide was not. However, many participants without these risk factors withdrew early. CONCLUSIONS: Failure to complete is a major problem in barrier method trials that seriously compromises the interpretation of results. Targeting retention efforts at women at high risk for early withdrawal is not likely to address the problem sufficiently.
Adult↗
Induced abortion: an overview for internists.
Internists care for many women who have had abortions and many who will seek abortions in the future. Each year, about 2% of all women of reproductive age have an abortion. Women having abortions tend to be young, white, unmarried, and early in pregnancy. Most abortions are done by suction curettage under local anesthesia in a freestanding clinic. However, medical abortion is growing in popularity as a nonsurgical alternative. The regimen approved by the U.S. Food and Drug Administration specifies mifepristone, 600 mg orally, followed 2 days later by misoprostol, 400 microg orally (within 49 days from last menses). Recent studies have recommended alternative approaches, such as mifepristone, 200 mg orally, followed in 1 to 3 days by misoprostol, 800 microg vaginally (up to 63 days). Medical abortion can be provided by a broader variety of physicians than can surgical abortion. The overall case-fatality rate for abortion is less than 1 death per 100,000 procedures. Infection, hemorrhage, acute hematometra, and retained tissue are among the more common complications. Referral back to the original abortion provider for management is advisable. Overall, induced abortion does not lead to late sequelae, either medical or psychiatric. Of importance, no link exists between induced abortion and later breast cancer. For physicians who are asked to help with a referral, the National Abortion Federation and Planned Parenthood Federation of America have helpful Web sites and networks of high-quality clinics. The cost of abortion (currently about 372 dollars at 10 weeks) has decreased in recent decades. Provision of ongoing contraception and encouragement of emergency contraception can reduce unintended pregnancies and the need for abortion.
Abortifacient Agents↗
Amniotic fluid embolism with second trimester pregnancy termination: a case report.
PURPOSE: Describe the diagnosis, clinical features, pathophysiology, treatment and anesthetic management of amniotic fluid embolism (AFE) in a patient undergoing second trimester pregnancy termination. CLINICAL FEATURES: A 30-yr-old gravida 2, para 1, woman was admitted for a dilatation and evacuation procedure for underlying intra-uterine fetal demise in her second trimester of pregnancy. Hypotension, shock, respiratory arrest, pulseless electrical activity, hemorrhage, disseminated intravascular coagulopathy, requiring cardiopulmonary resuscitation and blood transfusion complicated her intraoperative care. AFE was considered the most likely cause of this intraoperative event. CONCLUSIONS: It is now recognized that the pathophysiological features of AFE are similar to a type-1 hypersensitivity reaction ranging from mild systemic reaction to anaphylaxis and shock. AFE has a high maternal and fetal morbidity and mortality rate, requiring prompt recognition and treatment. In patients with cardiovascular instability, the treatment of AFE is similar to anaphylaxis requiring aggressive fluid hydration, cardiopulmonary resuscitation, administration of blood products and the use of vasopressors.
Adult↗
A randomized trial of saline solution-moistened misoprostol versus dry misoprostol for first-trimester pregnancy failure.
OBJECTIVE: The purpose of this study was to estimate whether the efficacy of treatment with intravaginal misoprostol for first-trimester pregnancy failure is enhanced by the addition of saline solution. STUDY DESIGN: Eighty women with embryonic/fetal death or anembryonic pregnancy were assigned randomly to receive either 800 microg of misoprostol with saline solution (group I, 41 women) or without (group II, 39 women). Treatment was repeated on day 3 if the gestational sac remained. Curettage was performed if the gestational sac remained on day 8 or as necessary during at least 30 days of follow-up. Data were analyzed with the Student t test and the chi(2) or Fisher exact test. RESULTS: By the first follow-up visit, 73% (group I) and 64% (group II) of women passed the gestational sac (P=.38). By the second follow-up visit, expulsion rates were 83% and 87%, respectively (P=.59). Five subjects in each group underwent curettage. CONCLUSION: Misoprostol is effective for the treatment of failed first-trimester pregnancy. The expulsion rate is not improved by adding saline solution.
Abortifacient Agents, Nonsteroidal↗
Prospective randomized, controlled study of postoperative pain after titanium silicone rubber clip or Silastic ring tubal occlusion.
OBJECTIVE: To determine if laparoscopic sterilization using the Filshie clip causes less postoperative pain as compared to the Falope ring during the first 24 h after surgery. STUDY DESIGN: Forty subjects were enrolled. Five milliliters of 0.5% bupivicaine was injected at each of the two incision sites and 5 mL was dripped onto each fallopian tube. Subjects then received one Filshie clip and Falope ring on opposite fallopian tubes; the side of occlusion was randomized. Subjects were questioned about pain prior to the first administration of analgesics postoperatively, 1 and 2 h after surgery, at discharge, and 24 h after surgery. RESULTS: Forty subjects completed the study; 32 without major deviations from protocol. There was no significant difference in pain between sides with the Filshie clip or Falope ring at any times evaluated. CONCLUSION: There was no significant reduction in the postoperative pain associated with the Filshie clip as compared to the Falope ring within 24 h after surgery.
Adult↗
A phase I comparative postcoital testing study of three concentrations of C31G.
BACKGROUND: C31G is a broad-spectrum antibacterial agent that shows contraceptive properties in vitro. This postcoital testing study evaluated the ability of three C31G concentrations, 0.5%, 1.0% and 1.7%, administered as a 3.5-mL dose of a vaginal gel to prevent sperm from entering mid-cycle cervical mucus. Irritation of the genitalia and acceptability were also assessed. METHOD: At baseline, a mid-cycle cervical mucus test and a postcoital test were performed within 24 h of each other without use of any study products to establish normal mid-cycle cervical mucus and sperm penetration. Subjects then completed up to three test cycles using one of the three concentrations of study product during intercourse. RESULTS: Twenty-two of the 61 women enrolled completed a baseline cycle and at least one test cycle. An average of 14.6 progressively motile sperm per high power field was seen at baseline. This was reduced to 0.3 after use of 0.5% C31G, 0.5 after use of 1.0% C31G, and 0.4 after use of 1.7% C31G. There was no significant difference between test products (p >/= 1.000) but each test product was significantly different from baseline (p < 0.002). Very little genital irritation was observed. There were more reports of leakage and messiness with increasing C31G concentration. CONCLUSION: This study suggests that all three concentrations of C31G are likely to give reasonable results in a contraceptive effectiveness trial. Based on the results of this and other trials, the 1.0% concentration has been selected for further development, including Phase III trials of contraceptive effectiveness.
Adult↗
Single and multiple exposure tolerance study of polystyrene sulfonate gel: a phase I safety and colposcopy study.
OBJECTIVES: To evaluate symptoms and signs of genital irritation, vaginal leakage and acceptability of polystyrene sulfonate (PSS), which is being studied as a vaginal contraceptive and microbicide. METHODS: Forty-nine women applied 2.5 mL of either 5% PSS, 10% PSS, PSS vehicle, or Conceptrol (a marketed spermicidal product containing 4% nonoxynol-9) for 6 consecutive days. RESULTS: All women completed the study except one in the Conceptrol group who experienced vaginal symptoms after her first use and was discontinued. After both the first use and after all uses, irritation was seen among more women in the Conceptrol group than in the PSS groups, reaching statistical significance with regard to any evidence of irritation, signs of irritation and product-related irritation. There were no adverse events that were serious, unexpected and related to product use in any group. The 5% concentration of PSS may be preferable in terms of leakage and acceptability. CONCLUSION: The results suggest that PSS has a safety profile comparable to that of the marketed nonoxynol-9 product, Conceptrol, and appears to be associated with less genital irritation.
Adolescent↗
Ability of the clinician and patient to predict the outcome of mifepristone and misoprostol medical abortion.
We performed this analysis to evaluate the ability of both women and their clinicians to predict pregnancy expulsion after using mifepristone and misoprostol for medical abortion up to 63 days gestation. Women who participated in a multicenter, randomized trial comparing misoprostol 6-8 h vs. 23-25 h after mifepristone attended a follow-up visit approximately 7 days after mifepristone treatment. Each subject was asked if she felt she had expelled the gestational sac. Clinicians also assessed if the sac had been expelled based on the woman's history. Vaginal ultrasonography was then performed to assess the uterine cavity. Of the 1080 women enrolled in the multicenter study, 931 (86.2%) who attended the first follow-up visit by study day 12 and did not have a uterine suction aspiration prior to this visit were included in this analysis. Vaginal ultrasonography at the first follow-up visit demonstrated expulsion in 915 [98.3%, 95% confidence interval (CI): 97.2-99.0] women. Overall, sensitivity, specificity, and positive and negative predictive values for subjects were 96.5%, 31.3%, 98.8% and 13.5%, respectively. When both the clinician and patient felt that the gestational sac had passed (n = 880 [94.5%, 95% CI: 92.9-95.9]), expulsion was confirmed by sonography in 99.1% (95% CI: 98.2-99.6) of cases. Women and clinicians are very accurate at determining expulsion of gestational sac during medical abortion with mifepristone and misoprostol without ultrasonography or a physical examination.
Abortifacient Agents, Nonsteroidal↗
A randomized Phase I vaginal safety study of three concentrations of C31G vs. Extra Strength Gynol II.
BACKGROUND: C31G is an antimicrobial and spermicidal agent that contains two surface-active compounds, cetyl betaine and myristamine oxide. It is being developed as a vaginal microbicide and contraceptive. METHOD: Three C31G concentrations (0.5%, 1.0% and 1.7%) were tested and compared with Extra Strength Gynol II(R), a marketed spermicide containing 3% nonoxynol-9 (N-9), in a randomized, double-blinded, Phase I, dose-escalation study to assess genital irritation (by subject report, visual examination at pelvic examination and colposcopy), plasma and vaginal lavage levels of C31G, product leakage, systemic safety and acceptability. Women were randomized to use 3.5 mL of one of the three C31G products or the N-9 gel at night for 7 days then twice daily for another 7 days. Pelvic and colposcopic evaluations were performed after 7 and 14 days of product use. RESULTS: The percent of women experiencing irritation in the 0.5% and 1.0% C31G groups in the study were similar to each other and were lower than the percent experiencing irritation in the 1.7% and N-9 groups, which were also similar to each other. Differences were statistically significant between 1.0% C31G vs. N-9 at 7 days and between 0.5% C31G and 1.0% C31G vs. N-9 at 14 days. There was no significant difference between groups in leakage or acceptability. No C31G was detected in the plasma of any volunteer. CONCLUSIONS: These results suggest that 0.5% and 1.0% C31G are less irritating to the female genital tract than 1.7% C31G or Extra Strength Gynol II.
Adolescent↗
How regular is regular? An analysis of menstrual cycle regularity.
We performed a retrospective analysis to ascertain how accurately women who believe that they have regular menstrual cycles estimate the length of their actual cycles. Data were extracted from a chart review of subjects from three different studies of barrier contraceptives. Subjects were between 18 and 40 years of age and reported "regular" prestudy menstrual cycles with a consistent cycle length between 21 and 35 days. Participants prospectively recorded their menses for the up to 30 weeks. Each subject's estimated cycle length was compared to the average of her actual cycle lengths and the range and variability in each individual's cycle length was calculated. A total of 786 cycles from 130 women who recorded 4 or more cycles were analyzed. The averages of the participants' estimated cycle lengths was similar to the prospective averages of their actual cycle lengths (29.0 +/- 2.7 days vs. 29.1 +/- 3.5 days, respectively, p = 0.8). Forty-six percent of all subjects had a cycle range of 7 days or more, and 20% had a cycle range of 14 days or more. The average length of menses was 5.2 +/- 1.0 days. When evaluating only women with cycle lengths from 21 to 35 days, the average length of menses was positively associated with the average actual cycle length (p = 0.04). Although the average of a woman's menstrual cycles compares favorably to her impression of her cycle length, the variability in menstrual cycle lengths is significant. This variation may have clinical impact on contraceptive practice, contraceptive research studies and pregnancy-related care.
Adolescent↗
A randomized comparison of misoprostol 6 to 8 hours versus 24 hours after mifepristone for abortion.
OBJECTIVE: To demonstrate equivalence between mifepristone 200 mg followed 6 to 8 hours later and 24 hours later by misoprostol 800 microg vaginally for abortion in women up to 63 days of gestation. METHODS: Mifepristone 200 mg was swallowed by 1,080 women after which they were randomly assigned to self-administer misoprostol intravaginally 6 to 8 hours later (group 1) or 23 to 25 hours later (group 2) at home. Participants returned for an evaluation, including transvaginal ultrasonography, 7 +/- 1 days after initiating treatment. Subjects who had not aborted were offered a second dose of misoprostol. All participants returned approximately 2 weeks after receiving mifepristone. Telephone contact was also attempted approximately 5 weeks after treatment. Treatment was considered a failure if a suction aspiration was performed for any indication. RESULTS: Complete abortion rates for groups 1 and 2 were 503 of 525 (95.8%, 95% confidence interval 93.7%, 97.3%) and 521 of 531 (98.1%, 95% confidence interval 96.6%, 99.1%), respectively, which were statistically equivalent. Side effects were significantly more common after mifepristone administration for women in group 2. Nausea, vomiting, and heavy bleeding were also significantly greater for women in group 2 after misoprostol treatment. Pain and subject acceptability were similar between groups. CONCLUSION: Mifepristone 200 mg followed 6 to 8 hours later by misoprostol 800 microg vaginally is as effective for abortion and has significantly fewer side effects as compared with regimens using a 24-hour dosing interval. Women receiving mifepristone and vaginal misoprostol for abortion can have the flexibility to administer the misoprostol as soon as 6 hours after using the mifepristone.
Abortifacient Agents, Nonsteroidal↗
Miscommunication between healthcare providers and patients may result in unplanned pregnancies.
Our objective was to examine the impact of prior healthcare provider counseling on previous use of contraception and knowledge of emergency contraception in women seeking surgical abortion. We performed a retrospective analysis of 342 patient charts from women seeking an office abortion in a private practice setting from January 1999 to June 2001. Data extracted included demographic information, primary method of contraception over the preceding few months, compliance with that method, contraceptive history, knowledge of emergency contraception and postabortion contraception. Patients were primarily white (69%) and unmarried (63%) and had private insurance that covered abortion services (72%). Only 19% of women were using a birth control method with no recognized potential failure. Twenty-two percent of women were using their birth control method correctly but experienced an event that put them at risk for pregnancy, 32% were using their birth control method incorrectly and 27% were using no birth control method at all. Miscommunication between patients and their healthcare provider(s) negatively affected use of a primary contraceptive method in 14% of patients. Of the 77% of women who did not know about emergency contraception, nearly two thirds had an identifiable event for which emergency contraception could have been used. Healthcare providers may contribute to the occurrence of unintended pregnancy if they provide poor medical advice or miscommunicate with patients.
Abortion, Legal↗
Feasibility study of the use of a daily electronic mail reminder to improve oral contraceptive compliance.
Women who ingest their oral contraceptive pill (OCP) as part of a daily routine are more likely use their OCPs correctly. This trial examines the feasibility of an electronic-mail (e-mail) reminder system to improve OCP compliance. An e-mail reminder was sent to 50 new OCP users daily for 3 months. Subjects sent an e-mail reply to confirm receipt. OCP compliance was recorded on diaries. Four subjects were discontinued for not checking their e-mail. Active participants missed a median of 18% of the e-mail reminders (range: 0-65%). A follow-up visit was scheduled after completion of three OCP cycles. Of the 40 subjects returning completed diaries, 50% missed no active pills at all and 20% missed at least one in each cycle. Most found the daily e-mail somewhat (65%) or very helpful (19%) for OCP compliance. Of those continuing OCPs, 64% wanted to continue receiving e-mail reminders at the completion of the study. Because inconsistent OCP use is a significant cause of unplanned conception, the use of e-mail to improve OCP compliance has the potential to decrease unintended pregnancies.
Adolescent↗
Mifepristone and misoprostol and methotrexate/misoprostol in clinical practice for abortion.
OBJECTIVE: The purpose of this study was to evaluate the efficacy, side-effect profile, and follow-up rates in women who obtain a medical abortion in a nonresearch setting. STUDY DESIGN: From December 1, 2000, to June 30, 2001, we prospectively followed 218 women who had been evaluated in our private office for medical abortion. Women received either mifepristone 200 mg orally followed 1 to 2 days later by self-administered misoprostol 800 microg vaginally or methotrexate 50 mg/m(2) intramuscularly followed 3 to 7 days later by self-administered misoprostol 800 microg vaginally. RESULTS: Of the 174 women who had a medical abortion, 148 women (85%) chose mifepristone/misoprostol, and 26 women (15%) chose methotrexate/misoprostol. In women up to 49 days of gestation, complete abortion occurred by the first follow-up visit in 82 of 86 women (95%; 95% CI, 89-99) and in 21 of 25 women (84%; 95% CI, 64-95) women, respectively. In women who used mifepristone/misoprostol from 50 to 63 days of gestation, complete abortions occurred in 56 of 59 women (95%; 95% CI, 86-99) women. Four women (2%; 95% CI, 1-6) were lost to follow-up. CONCLUSION: Medical abortion with mifepristone/misoprostol and with methotrexate/misoprostol can be provided in a nonresearch setting with efficacy similar to that reported in the medical literature for research protocols.
Abortifacient Agents, Nonsteroidal↗
Pharmacoeconomics of medical abortion: a review of cost in the United States, Europe and Asia.
Procedures for the termination of pregnancy have existed for many years. Vacuum aspiration, otherwise referred to as 'surgical' abortion, is a very common and safe procedure. Its efficacy and acceptability has been established and its complication rate is low. Medical abortion is a much more recent phenomenon. It is defined as early pregnancy termination with the use of abortion inducing medications, without surgery [1]. In contrast to surgical abortion, medical abortion is not as routinely offered, nor are many providers comfortable with its use. Medical abortion regimens currently available throughout the world include mifepristone (Mifeprex trade mark, Aventis Pharma AG) and a prostaglandin analogue (usually misoprostol), methotrexate and misoprostol and misoprostol (Cytotec trade mark, CD Searle & Co.) alone. In the US, minimal information exists directly comparing medical to surgical abortion. Most abortion surveillance data was collected by the Centers for Disease Control prior to the approval of mifepristone. In contrast, there is over a decade's worth of experience from Europe with both the use and provision of medical abortion. A complete review of these issues must include background information on the history and incidence of abortion, who chooses to get an abortion, who provides that service and at what cost. The cost issue is discussed using three different viewpoints: cost to the patient, cost to the provider, cost to society - mainly in the form of government expenditure and savings. Following the cost analysis, there is a summary of relevant information from countries in Europe, primarily the UK, France, Sweden and countries in Asia, mainly China and India.
Abortion, Induced↗
Current medical abortion care.
Medical abortion using mifepristone and a prostaglandin analogue is a highly effective option for early abortion. Since the clinical introduction of mifepristone to the world in 1988, millions of women have had the opportunity to have a safe abortion without primary surgical intervention. The standard method of providing medical abortion has evolved through well-done studies to develop regimens that decrease cost and time to abortion. Currently, mifepristone with misoprostol is the most widely used medical abortion regimen. The most effective option available involves mifepristone 200 mg followed at least 24 hours later by misoprostol 800 microg vaginally. Women can self-administer the misoprostol, with complete abortion rates exceeding 95%. Researchers continue to refine the available regimens to improve outcomes and acceptability.
Abortifacient Agents, Nonsteroidal↗