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C Ellertson

Publications and source records attributed to C Ellertson.

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

Updated estimates of the effectiveness of the Yuzpe regimen of emergency contraception.

The purpose of this study was to provide revised estimates of the effectiveness of the Yuzpe method of emergency contraception. Through a literature search, we identified eight studies that present the number of women treated and outcome of treatment by cycle day of unprotected intercourse relative to expected day of ovulation. Using five sets of external estimates of conception probabilities by cycle day of intercourse among women not using contraception, we assessed the effectiveness of the Yuzpe regimen. The 45 estimates of effectiveness, based on eight separate studies and the eight studies combined and five different sets of conception probabilities by cycle day, ranged from a low of 56.4% to a high of 89.3%. Our preferred point estimate is that the Yuzpe regimen reduces the risk of pregnancy by 74.1%, with a 95% confidence interval extending from 62.9% to 79.2%. True effectiveness is likely to be > 74% because treatment failures (observed pregnancies) include women who were already pregnant when treated and women who became pregnant after being treated.

Contraception↗
PubMed1999

Misoprostol used alone for the termination of early pregnancy. A review of the evidence.

Increased access to medical methods of abortion could significantly reduce maternal mortality, especially in developing countries. In light of the political and commercial difficulties in distributing the abortifacient mifepristone, the widely studied mifepristone-misoprostol regimen may not be sufficiently available in the near future. Thus, researchers have begun to look for alternative regimens, including regimens using misoprostol alone. This article reviews the current available evidence on the potential of a misoprostol-alone regimen for medical abortion. Although the data are varied and difficult to compare, recent studies indicate that a misoprostol-alone regimen could be safe and effective as a method of medical abortion. Misoprostol is widely marketed around the world for its other indications and is inexpensive, stable in tropical climates, easy to transport, and simple to administer. A misoprostol-alone regimen of medical abortion could thus greatly improve the access to safe medical abortion services by women in developing countries.

Abortifacient Agents, Nonsteroidal↗
PubMed1999

Mifepristone-misoprostol medical abortion: home administration of misoprostol in Guadeloupe.

Mifepristone-misoprostol medical abortion promises to revolutionize reproductive health-care. Several simplifications of the standard three clinic visit regimen may be possible, however. Particularly in developing countries, access to the method can be greatly increased by eliminating the longest clinic visit. Indeed, shortly after mifepristone's introduction in Guadeloupe, a semi-developed Caribbean territory administered by France, in 1991, two of the authors conducted a small prospective study of a one treatment-visit regimen. The study regimen was subsequently adopted as the standard of care for medical abortion on the island. Women (n = 92) with amenorrhea of < or = 49 days received 600 mg mifepristone under clinical supervision and were given 400 micrograms oral misoprostol for home administration 2 days later, returning 2 weeks later for follow-up. The success rate (95.4%) is comparable to rates found when both drugs are administered in the clinic and to rates from a similar study conducted recently in the United States. Adverse events were also comparable to protocols requiring in-clinic administration of misoprostol. Protocol adherence appeared to be excellent and loss to follow-up was rare. We suggest that home administration of misoprostol can be safe and effective in most nonindustrialized settings.

Abortifacient Agents, Nonsteroidal↗
PubMed1999

Estimating the efficacy of medical abortion.

Comparisons of the efficacy of different regimens of medical abortion are difficult because of the widely varying protocols (even for testing identical regimens), divergent definitions of success and failure, and lack of a standard method of analysis. In this article we review the current efficacy literature on medical abortion, highlighting some of the most important differences in the way that efficacy has been analyzed. We then propose a standard conceptual approach and the accompanying statistical methods for analyzing clinical trials of medical abortion and to explain how clinical investigators can implement this approach. Our review reveals that research on the efficacy of medical abortion has closely followed the conceptual model used for analysis of surgical abortion. The problem, however, is that, whereas surgical abortion is a discrete event occurring in the space of a few minutes or less, medical abortion is a process typically lasting from several days to several weeks. In this process, two events may occur that are not possible with surgical abortion. First, the woman can opt out of the process before a fair determination of efficacy can be made. Second, the process of medical abortion allows time for surgical interventions that may be convenient for the clinician but not strictly necessary from a medical perspective. Another difference from surgical abortions is that, for medical abortions, different medical abortion protocols specify different waiting periods, giving the drugs less time to work in some studies than in others before a determination of efficacy is made. We argue that, when analyzing efficacy of medical abortion, researchers should abandon their close reliance on the analogy to surgical abortion. In fact, medical abortion is more appropriately analyzed by life table procedures developed for the study of another fertility regulation technology; contraception. As with medical abortion, a woman initiating use of a contraceptive method can change her mind after some period of exposure and opt out. Also, as with medical abortion, a contraceptive can fail, usually with the risk of failure depending heavily on whether or not the woman follows the protocol for that method precisely. Finally, as with medical abortion, medical conditions may arise that necessitate discontinuing use of the contraceptive method. In both cases, these medical conditions are sometimes open to interpretation or subject to the skill, judgment, or experience of the clinician involved. The appropriate information to collect for a multiple decrement life table analysis of medical abortion includes data on compliance with the protocol, timing of the event of interest (abortion) when it is observable, and, because we argue that these should be regarded as events of interest, a typology of any surgical interventions that are conducted during the woman's participation in the study.

Abortion, Incomplete↗
PubMed1999

Emergency contraception in Mexico City: what do health care providers and potential users know and think about it?

Emergency contraception promises to reduce Mexico's high unwanted pregnancy and unsafe abortion rates. Because oral contraceptives are sold over-the-counter, several emergency contraceptive regimens are already potentially available to those women who know about the method. Soon, specially packaged emergency contraceptives may also arrive in Mexico. To initiate campaigns promoting emergency contraception, we interviewed health care providers and clients at health clinics in Mexico City, ascertaining knowledge, attitudes, and practices concerning the method. We found limited knowledge, but nevertheless cautious support for emergency contraception in Mexico. Health care providers and clients greatly overestimated the negative health effects of emergency contraception, although clients overwhelmingly reported that they would use or recommend it if needed. Although providers typically advocated medically controlled distribution, clients believed emergency contraception should be more widely available, including in schools and vending machines with information prevalent in the mass media and elsewhere.

Adolescent↗
PubMed1999

Emergency contraception in Nairobi, Kenya: knowledge, attitudes and practices among policymakers, family planning providers and clients, and university students.

To gauge knowledge, attitudes, and practices about emergency contraception in Nairobi, Kenya, we conducted a five-part study. We searched government and professional association policy documents, and clinic guidelines and service records for references to emergency contraception. We conducted in-depth interviews with five key policymakers, and with 93 family planning providers randomly selected to represent both the public and private sectors. We also surveyed 282 family planning clients attending 10 clinics, again representing both sectors. Finally, we conducted four focus groups with university students. Although one specially packaged emergency contraceptive (Postinor levonorgestrel tablets) is registered in Kenya, the method is scarcely known or used. No extant policy or service guidelines address the method specifically, although revisions to several documents were planned. Yet policymakers felt that expanding access to emergency contraception would require few overt policy changes, as much of the guidance for oral contraception is already broad enough to cover this alternative use of those same commodities. Participants in all parts of the study generally supported expanded access to emergency contraception in Kenya. They did, however, want additional, detailed information, particularly about health effects. They also differed over exactly who should have access to emergency contraception and how it should be provided.

Contraceptives, Postcoital↗
PubMed1999

Providing mifepristone-misoprostol medical abortion: the view from the clinic.

In order to gather information about the practical aspects of offering medical abortion, we conducted focus group discussions at each of 17 sites participating in the first large-scale, multi-center trial of mifepristone-misoprostol abortion in the United States. The sites were chosen to represent diverse practice settings (Planned Parenthood affiliates, university research clinics, private practices, and feminist health centers) and geographical regions. Seventy-seven clinic staff members (including counselors, administrators, physicians and other health workers) participated. They discussed the impact of adding a medical method to their clinic structure, their own preferences about offering the method, and their perceptions of women's preferences. Staffing a medical abortion service requires different skills and temperament than those needed for a surgical service. Nearly all participants were eager to begin offering the medical method, and they perceived a strong demand for it on the part of women. They had mixed feelings about the type of provider who should offer the method, but nearly all felt that the regimen could be greatly simplified from the three-visit regimen tested in the trial.

Abortifacient Agents↗
PubMed1998

New estimates of the effectiveness of the Yuzpe regimen of emergency contraception.

The purpose of this study was to provide new estimates of the effectiveness of the Yuzpe method of emergency contraception and to offer correctly computed estimates of the confidence intervals for estimated effectiveness rates. Through a literature search, seven studies that present the number of women treated and outcome of treatment by cycle day of unprotected intercourse relative to expected day of ovulation were identified. Probabilities of conception by cycle day of intercourse among women not using contraception and the associated variance-covariance matrix from five other datasets were estimated, and these external estimates were used to assess the effectiveness of the Yuzpe regimen. The 40 estimates of effectiveness, based on seven separate studies and the seven studies combined and five different sets of conception probabilities by cycle day, ranged from a low of 44.2% to a high of 88.7%. The preferred point estimate is that emergency contraceptive pills reduce the risk of pregnancy by 75.4%, with a 95% confidence interval extending from 65.6% to 82.4%. True effectiveness is likely to be at least 75% because treatment failures (observed pregnancies) include women who were already pregnant when treated and women who became pregnant after being treated.

Coitus↗
PubMed1998

Blood loss with mifepristone--misoprostol abortion: measures from a trial in China, Cuba and India.

OBJECTIVE: We compared bleeding patterns following early mifepristone-misoprostol abortion with those following early surgical abortions ( < or = 56 days gestation LMP). We analyzed women's reports of their bleeding and clinical measures of blood loss, and modeled the relationships between different bleeding measures and indicators of success and satisfaction. METHOD: Using data from a multicenter trial held in China, Cuba and India, we fit bivariate and multivariate models to analyze bleeding patterns, controlling for a range of demographic, experiential and medical factors (n = 1373). RESULT: Medical abortion patients perceived their bleeding to be heavier than did the surgical patients; however, there were few statistically significant differences in clinical measures of blood loss between the two groups, and blood loss rarely represented a medical problem. Nationality, far more than actual levels of bleeding, influenced women's impressions about blood loss. Although medical abortion patients saw their bleeding as heavier than did the surgical patients, their perceptions of heavier bleeding did not prevent them from having higher satisfaction levels. One exception was that if bleeding exceeded prior expectations, women with the medical method were more likely to be dissatisfied. Pain and cramps, which often accompanied bleeding, were an independently significant factor in predicting satisfaction with the method. CONCLUSION: In order for women to know what to expect with medical abortion, they must be informed beforehand about the level of bleeding that generally accompanies the procedure vs. excessive bleeding that would signal a clinical problem.

Abortifacient Agents↗
PubMed1998

Abortion, revised: participants in the U.S. clinical trials evaluate mifepristone.

This paper centers on the questions: How do non-surgical abortion methods affect private experiences of abortions? How might they influence public conceptions of abortion? Drawing on interviews with clients who participated in the 1994-95 U.S. clinical trials of mifepristone at one trial site (conducted during the trials), and focus group interviews conducted with health care workers at all 17 trial sites (after the trials were completed), we examine participants' evaluations of this method of abortion. Surgical abortion functioned as the reference point by which research participants assessed medical abortion. They discussed mifepristone abortion in terms of nature and invasion, privacy and bodily integrity, denial and agency. Clients frequently portrayed mifepristone abortion as a better moral choice than surgical abortion--in some cases even depicting it as not-really-an-abortion but rather as a miscarriage. Clients felt that mifepristone offered them a greater measure of control over their abortion experiences. Health care providers offered critical analysis of their clients' perceptions, yet affirmed the potential of medical abortion to offer women greater variety and latitude in procreative decision-making, and perhaps even to depoliticize the issue of abortion in the U.S. by thwarting the efforts of anti-abortionists to target providers and aborting women.

Abortifacient Agents, Steroidal↗
PubMed1998

Should emergency contraceptive pills be available without prescription?

Leading health agencies, including the World Health Organization and the US Food and Drug Administration, consider emergency contraceptive pills (ECPs) safe and effective and have called for better access to them. Yet debate about whether ECPs should continue to be available by prescription only has been limited. After measuring the characteristics of ECPs against criteria developed to assess the necessity for prescription status for drugs generally, we argue that ECPs can safely be marketed over the counter. Professional assistance is not necessary since the woman diagnoses her own need for the pills and takes them herself. ECPs do not need to be adjusted for the individual woman and pose no potential threat of overdose or addiction. There are no contraindications except confirmed pregnancy (in which case the therapy will not work), and monitoring is not necessary. We conclude that prescription requirements that keep ECPs from women provide little, if any, benefit.

Contraceptives, Postcoital↗
PubMed1997

Safety, efficacy, and acceptability of medical abortion in China, Cuba, and India: a comparative trial of mifepristone-misoprostol versus surgical abortion.

OBJECTIVE: We investigated safety, efficacy, and acceptability of an oral regimen of medical abortion compared with surgical abortion in three developing countries. STUDY DESIGN: Women (n = 1373) with amenorrhea < or = 56 days chose either surgical abortion (as provided routinely) or 600 mg of mifepristone followed after 48 hours by 400 micrograms of misoprostol. This is the appropriate design for studying safety, efficacy, and acceptability among women selecting medical abortion over available surgical services. RESULTS: The medical regimen had more side effects, particularly bleeding, than did surgical abortion but very few serious side effects. Failure rates for medical abortion, although low, exceeded those for surgical abortion: 8.6% versus 0.4% (China), 16.0% versus 4.0% (Cuba), and 5.2% versus 0% (India). Nearly half of failures among medical clients were not true drug failures, however, but surgical interventions not medically necessary (acceptability failures or misdiagnoses). Women were satisfied with either method, but more preferred medical abortion. CONCLUSION: Medical abortion can be safe, efficacious, and acceptable in developing countries.

Abortifacient Agents↗
PubMed1997

Preventing unintended pregnancy: the cost-effectiveness of three methods of emergency contraception.

OBJECTIVES: This study examined the cost-effectiveness of emergency contraceptive pills, minipills, and the copper-T intrauterine device (IUD) as emergency contraception. METHODS: Cost savings were modeled for both (1) a single contraceptive treatment following unprotected intercourse and (2) emergency contraceptive pills provided in advance. RESULTS: In a managed care (public payer) setting, a single treatment of emergency contraception after unprotected intercourse saves $142 ($54) with emergency contraceptive pills and $119 ($29) with minipills. The copper-T IUD is not cost-effective as an emergency contraceptive alone, but savings quickly accrue as use continues. Advance provision of emergency contraceptive pills to women using barrier contraceptives, spermicides, withdrawal, or periodic abstinence saves from $263 to $498 ($99 to $205) annually. CONCLUSIONS: Emergency contraception is cost-effective whether provided when the emergency arises or in advance to be used as needed. Greater use of emergency contraception could reduce the considerable medical and social costs of unintended pregnancies.

Contraceptives, Oral, Hormonal↗
PubMed1997

Mandatory parental involvement in minors' abortions: effects of the laws in Minnesota, Missouri, and Indiana.

OBJECTIVES: This study examined the effects of parental involvement laws on the birth rate, in-state abortion rate, odds of interstate travel, and odds of late abortion for minors. METHODS: Poisson and logistic regression models fitted to vital records compared the periods before and after the laws were enforced. RESULTS: In each state, the in-state abortion rate for minors fell (relative to the rate for older women) when parental involvement laws took effect. Data offered no empirical support for the proposition that the laws drive up birth rates for minors. Although data were incomplete, the laws appeared to increase the odds of a minor's traveling out of state for her abortion. If one judges from the available data, minors who traveled out of state may have accounted for the entire observed decline in the in-state abortion rate, at least in Missouri. The laws appeared to delay minors' abortions past the eighth week, but probably not into the second trimester. CONCLUSIONS: Several empirical arguments used against and in support of parental involvement laws do not appear to be substantiated.

Abortion Applicants↗
PubMed1996

The Yuzpe regimen of emergency contraception: how long after the morning after?

OBJECTIVE: To determine whether failure of the Yuzpe method of emergency contraception (which involves taking a higher than usual dose of ordinary combined oral contraceptives within 72 hours after unprotected intercourse, with a second dose taken 12 hours later) depends on the interval between intercourse and treatment. DATA SOURCES: We searched the literature for studies in which investigators separately reported both the number of women treated with the Yuzpe regimen and the resulting pregnancies when treatment was started on the first, second, and third days after unprotected intercourse. Searches of the electronic data bases MEDLINE, POPLINE, EMBASE, and BIOSIS were supplemented by scrutiny of the bibliographies of all papers identified through the electronic search. METHODS OF STUDY SELECTION: We identified nine published studies that present the number of women treated and outcome of treatment by time since unprotected intercourse. We included all nine studies in our analysis. TABULATION, INTEGRATION, AND RESULTS: Differences in failure rates by time of treatment adjusted for study-site effects were analyzed using logistic regression. We found no significant differences in failure rates when therapy was started on the first, second, or third day after unprotected intercourse. The large sample size ensured a power of 76% to reject the null hypothesis of equal failure rates when the odds of failure on the third day are twice those on the first and second days. CONCLUSION: Our results have two clinical implications. First, insistence on taking the first dose as soon as possible may be counterproductive in circumstances when taking the second dose 12 hours later would be difficult. Second, clinical protocols that deny treatment after 72 hours may be excessively restrictive, particularly if the alternative of emergency insertion of a copper intrauterine device is not immediately available or appropriate.

Clinical Trials as Topic↗