Biomedical subjects

Kelly Blanchard

Publications and source records attributed to Kelly Blanchard.

18 recordsLinked to original sources

PubMed2006

Acceptability of Carraguard vaginal gel use among Thai couples.

OBJECTIVES: To evaluate the acceptability of candidate microbicide Carraguard among couples participating in a safety trial. STUDY DESIGN: A 6-month randomized, placebo-controlled trial was conducted in sexually active, low-risk couples in Thailand. METHODS: Couples who were monogamous, HIV uninfected, and not regular condom users were enrolled. Acceptability data were collected through structured questionnaires at repeated intervals. At the closing study visit, participants were asked questions about hypothetical product characteristics and future use. Compliance with gel use was assessed by questionnaires, coital diaries, and tracking of used and unused applicators. RESULTS: Among 55 enrolled couples, follow up and adherence with gel use were high and sustained, with 80% of women using gel in over 95% of vaginal sex acts. Because acceptability results from Carraguard and placebo arms were similar, they were combined for this analysis. Overall, 92% of women and 83% of men liked the gel somewhat or very much; 66% of women and 72% of men reported increased sexual pleasure with gel use; and 55% of women and 62% of men reported increased frequency of intercourse. Only 15% of women but 43% of men thought that gel could be used without the man knowing. Although men and women had similar views overall, concordance within couples was low, with no kappa coefficients above 0.31. CONCLUSION: Carraguard gel use was acceptable to low-risk couples in northern Thailand. Reported associations between gel use and increased sexual pleasure and frequency suggest a potential to market microbicide products for both disease prevention and enhancement of pleasure.

Adult↗

PubMed2006

Safety and acceptability of the candidate microbicide Carraguard in Thai Women: findings from a Phase II Clinical Trial.

OBJECTIVE: To determine the safety and acceptability of vaginal application of Carraguard, a carrageenan-derived candidate microbicide gel. DESIGN: A randomized, placebo-controlled, triple-blinded clinical trial was conducted in Chiang Rai, northern Thailand. METHODS: Women were asked to insert one applicator of study gel vaginally at least three times per week (with or without sex) and to use gel with condoms every time they had sex. Safety was assessed by visual inspection of the vagina and cervix, changes in vaginal flora and self-reported symptoms at day 14, month 1 and then monthly for up to 1 year. Acceptability was assessed through reported use of the gel, return of used and unused applicators, and quarterly interviews. RESULTS: One hundred sixty-five women were randomized: 83 to Carraguard and 82 to the placebo (methylcellulose gel) group. Study gel use was similarly high in both groups throughout the trial with an average of four applicators per week. Carraguard use was not associated with abnormal genital clinical findings, abnormal vaginal flora, Pap smear abnormalities or other abnormal clinical signs or symptoms. Adverse events were mostly mild, not attributed to gel use, and similarly distributed between groups. Participants in both groups reported high acceptability. CONCLUSIONS: Carraguard can safely be used an average of four times per week with or without sex and is acceptable to Thai women. A Phase III efficacy trial of Carraguard is warranted and is currently ongoing in South Africa.

Administration, Intravaginal↗

PubMed2006

Barriers to contraceptive use in product labeling and practice guidelines.

Many contraceptives are encumbered with potentially unnecessary restrictions on their use. Indeed, fear of side effects, fostered by alarmist labeling, is a leading reason that women do not use contraceptives. In the United States, hormonal methods currently require a prescription, although research suggests that women can adequately screen themselves for contraindications, manage side effects, and determine an appropriate initiation date, leaving little need for routine direct physician involvement. Sizing, spermicidal use, and length-of-wear limits burden users of cervical barriers and may be unnecessary. Despite recent changes in the labeling of intrauterine devices, clinicians commonly restrict use of this method and in some countries may limit the types of providers authorized to insert them. Although in some cases additional research is necessary, existing data indicate that evidence-based demedicalization of contraceptive provision could reduce costs and improve access.

Contraception Behavior↗

PubMed2006

Risk of pregnancy and external validity in clinical trials of emergency contraception.

OBJECTIVES: To compare women who enroll in emergency contraception (EC) trials to those who decline and to understand why eligible women decline to participate. METHODS: Data were collected from all women seeking EC (n = 5,787) at three clinics in the USA and UK during a period of nearly 1 year (from September 1997 to August 1998). The main outcome measures were pregnancy risk calculated by adjusted cycle day of ovulation. RESULTS: Enrolled and non-enrolled women had similar mean ages and similar mean cycle lengths. However, the enrolled and non-enrolled groups were different with respect to adjusted cycle day of unprotected sexual intercourse (UPSI), the regularity of their cycles, recent hormone use, breastfeeding, the number of other acts of UPSI they had engaged in during the same cycle, and their willingness to participate in the study. Expected pregnancy risk among enrolled patients was higher than among non-enrolled EC seekers (6.5% vs 5.0%, p<0.001, calculated using Dixon conception probabilities, and 5.4% vs 4.6%, p = 0.086, calculated using Trussell conception probabilities). Unwillingness to take part in the study was the most common reason women did not enrol in the trial. Otherwise-eligible women most often declined to enrol because they were concerned about the effectiveness of the trial regimen. CONCLUSIONS: Women in EC trials are likely to face higher pregnancy risk than the general population. Clinical trials might overestimate the number of pregnancies averted by treatment because the number of expected pregnancies in trial populations is not representative of the population of all EC seekers. This information could be useful in projecting the public health impact of expanded EC access.

Adolescent↗

PubMed2005

[To the editor].

Explore the source record for details and available documents.

Databases, Bibliographic↗

PubMed2005

Misoprostol alone for early abortion: an evaluation of seven potential regimens.

INTRODUCTION: A growing body of literature has shown that misoprostol alone could be effective for early medical abortion. We evaluated seven potential regimens in women up to 56 days of gestation in order to potentially identify an optimal regimen. METHODS: In phase I of the study, women requesting early abortion were randomized to one of three misoprostol regimens (4x400 microg po every 3 h, 2x800 microg po every 6 h, 1x600 pv microg); in phase II, women were randomized to one of two regimens (2x800 microg po every 3 h, 1x800 pv microg). In phase III, we consecutively tested two regimens (800 microg pv wetted with saline repeated after 24 h if intact gestational sac, 2x800 microg pv wetted with saline) to validate previously published results. RESULTS: Although most women experienced some side effects, all regimens were tolerable and acceptable. Five of the seven regimens resulted in complete abortion rates of 60% or less. Only repeated doses of 800 microg pv misoprostol resulted in efficacy exceeding 60%. DISCUSSION: Misoprostol-alone abortion regimens using oral misoprostol are too ineffective for clinical use or further investigation. Regimens with repeated dosing of misoprostol 800 microg pv warrant further study to find the optimal treatment protocol.

Abdominal Pain↗

PubMed2005

Medical abortion: the possibilities for introduction in the public sector in South Africa.

Medical abortion is safe and effective and has been approved for use in early termination of pregnancy in South Africa since 2001. The Department of Health is currently considering its introduction in the public health sector. The attitudes of women seeking abortion and of health care providers towards medical abortion have not previously been described. Data were derived from a quantitative survey of 673 women attending abortion services in the provinces of Gauteng, Mpumalanga and the Western Cape. In-depth interviews in Soweto and Cape Town were conducted with 20 public health doctors, nurses, a social worker and facility managers, and in Cape Town with four provincial policymakers. Although medical abortion was not yet being offered, 21% of women interviewed were early enough in pregnancy (eight weeks or less) to be eligible for medical abortion. Access to health facilities, including those for abortion, was reasonable for urban women but more limited for rural women. Rural women also incurred greater travel costs to reach a facility. Most women thought medical abortion would be acceptable and would have been willing to try it, had it been available. Policymakers and providers were supportive, as they felt medical abortion could relieve the burden on current services. How to increase access to abortion services in rural areas needs to be addressed.

Abortifacient Agents↗

PubMed2005

Pharmacists' knowledge and perceptions of emergency contraceptive pills in Soweto and the Johannesburg Central Business District, South Africa.

CONTEXT: In South Africa, emergency contraceptive pills are available directly from pharmacies without a prescription, yet few studies have assessed pharmacists' knowledge of and attitudes toward the medication. METHODS: In-person interviews were conducted with 34 pharmacists practicing in Soweto and the Johannesburg Central Business District, from February through April 2003. The pharmacists provided data on their knowledge of emergency contraceptive pills and their attitudes toward providing the medication to women in specific situations. RESULTS: Nearly all pharmacists sold at least one of the two types of dedicated emergency contraceptive pills available in South Africa. Although most had accurate knowledge about the method's dosing schedule, side effects and mechanism(s) of action, more than half erroneously believed that repeated use posed health risks. A large majority of pharmacists believed the pills should be available to rape victims, to single or married women and to women who had never given birth, but almost half did not think the pills should be given to women younger than 18, and a fourth said they would not give them to women with a late menstrual period. About one-third to half of pharmacists supported advance provision of the medication under certain circumstances. Most were willing to display promotional materials on emergency contraceptives in their pharmacies. CONCLUSIONS: Interventions aimed at educating pharmacists about the benefits of emergency contraceptive pills, especially for adolescents, are needed. Government and medical authorities should take advantage of pharmacists' willingness to display educational materials as a way to increase women's knowledge and use of the medication in South Africa.

Adult↗

PubMed2004

As often as needed: appropriate use of emergency contraceptive pills.

Previous research has established that emergency contraceptive pills are safe and have the potential to reduce unintended pregnancy; however, policy makers, providers and even women themselves have expressed concern about repeat use of the method. Evidence regarding the safety, efficacy and frequency of repeat use show that the method is safe and effective, even when used multiple times. Reported rates of repeat use are actually lower than would be expected, and needed, based on the frequency of unprotected intercourse and contraceptive failure reported in most countries. Healthcare providers should encourage use of emergency contraceptive pills as a backup after recognizable failure of barrier methods or other hormonal contraceptive methods, and should expect that women may need emergency contraceptive pills multiple times during their reproductive years.

Contraceptives, Oral, Combined↗

PubMed2004

Side effects of the Yuzpe regimen of emergency contraception and two modifications.

We investigated side effects after the standard Yuzpe regimen or two modifications: substituting norethindrone as the progestin or eliminating the second dose. We also examined the impact of taking either dose with food. Nearly two thirds of women reported at least one side effect, the majority of which were mild or moderate. Women in our study experienced more side effects after the second dose than after the first. Taking the first dose within 1 h of a meal or snack was associated with increased nausea and vomiting; taking the second dose within 1 h of a meal or snack was associated with decreased nausea and vomiting. A targeted approach to prophylactic antiemetic use could reduce the number of women given these drugs, and the number who experience unnecessary side effects. The impact of counseling on side effects should be further evaluated.

Chemistry, Pharmaceutical↗

PubMed2004

Oral contraceptives and cervical cancer: critique of a recent review.

A recent review article by Smith et al. in The Lancet purports to find a causal relationship between long-term use of oral contraceptives (OCs) and cervical cancer. While we endorse the search for such a relationship, we felt it important to critically examine Smith et al.'s review process and, as a result, we have questions about the validity of their conclusions. In our view, the findings of published articles as presented by Smith et al. do not confirm a causal connection between long-term use of OCs and cervical cancer. Our goal is not to conduct another formal review of the evidence, but to evaluate whether Smith et al. have met the burden of proof for establishing a causal relationship. Given the importance of OCs to women the world over, we urge reproductive health professionals to consider this issue carefully before accepting that a causal relationship exists.

Case-Control Studies↗

PubMed2004

Comparative study between single dose 600 microg and repeated dose of oral misoprostol for treatment of incomplete abortion.

OBJECTIVE: To evaluate and compare the effectiveness and side effects of two regimens of oral misoprostol, single dose (600 microg) and repeated dose (1200 microg), in the treatment of incomplete abortion. METHODS: A prospective randomized controlled trial was conducted. One-hundred women who had incomplete abortion (gestational age < 20 weeks) and consented to randomization by computer-generated randomization model prior to treatment. A single oral 600-microg dose or repeated oral dose after 4 h (total 1200 microg) was given to the randomized women. RESULTS: The overall incidence of complete abortion was 86.9%. This incidence was not statistically different between the single-dose and repeated-dose groups (81.6% vs. 92%, p > 0.05). However, there was a significantly decreased incidence of diarrhea (18.4% vs. 40%, p < 0.05) with the use of single-dose treatment. Overall rate of acceptability and tolerable side effects were 88.9% and 97.9%, respectively. These rates were similar in both groups (87.8% vs. 90% and 98% vs. 98%, p > 0.05). CONCLUSIONS: Oral misoprostol may be a practical alternative in the management of incomplete abortion. Oral misoprostol is acceptable and tolerable to women. Single-dose regimen is as effective as repeated-dose regimen, with a reduction in the incidence of diarrhea.

Abortifacient Agents, Nonsteroidal↗

PubMed2004

Two regimens of misoprostol for treatment of incomplete abortion.

OBJECTIVES: Misoprostol shows promise for treatment of incomplete abortion. We evaluated 2 simple misoprostol regimens to estimate whether they were effective in treating incomplete abortion. METHODS: A total of 169 women was randomly assigned to either a single or double dose of 600 microg misoprostol. The women, who would have received a surgical evacuation of the uterus for incomplete abortion, were patients at 2 hospitals in Bangkok, Thailand. The 2 groups of women were compared for success of treatment (no need for surgical evacuation), side effects, and acceptability. RESULTS: Sixty-six percent of women in the single-dose group and 70% of women in the double-dose group had complete abortions with misoprostol. More than 90% of women in the single- and double-dose groups reported that the side effects were tolerable; frequency of side effects was similar between the 2 groups. Women found the treatment acceptable. Approximately 90% of women in both groups would recommend the treatment to a friend. Acceptability and efficacy were different at the 2 participating clinics. CONCLUSION: Misoprostol is an effective treatment for incomplete abortion. Simple regimens may be as effective as more complicated ones and a single dose of 600 microg should be further evaluated in larger trials.

Abortifacient Agents, Nonsteroidal↗

PubMed2003

Evaluation of an emergency contraception advance provision service.

Timely access to emergency contraception (EC) could increase use when needed, and potentially lead to improved efficacy. We evaluated an advance provision service in the UK. Women were supportive of the service. They indicated that having EC on hand would not change their regular contraceptive use, and supported wider dissemination of information on the service, particularly to younger women. Although some women were supportive of further deregulation of EC, many cited fear of "abuse" or health risks of EC as reasons for strict control. We conclude that advance provision services increase access to EC and are particularly important where EC is not yet available from pharmacists. Providers and women need accurate information on the safety of EC. Uptake of advance provision services could be improved by providing subsidized or free EC to those who cannot pay, and by targeting information to younger women.

Adolescent↗

PubMed2003

Modifying the Yuzpe regimen of emergency contraception: a multicenter randomized controlled trial.

OBJECTIVE: Emergency contraceptives can prevent unintended pregnancy after unprotected intercourse. The best-studied regimen ("Yuzpe") consists of ordinary combined oral contraceptives containing levonorgestrel and ethinyl estradiol. Women traditionally take one dose within 72 hours after unprotected intercourse, and a second dose 12 hours later. Historically, half experience nausea and a fifth vomit. The purpose of this study was to determine whether 1). women could use combined oral contraceptives other than those containing levonorgestrel and 2). eliminating the second dose improves comfort and convenience. METHODS: Women presenting within 72 hours after unprotected intercourse were randomized to receive 1). standard two-dose Yuzpe, 2). a variant of Yuzpe substituting norethindrone for levonorgestrel, or 3). only the first dose of Yuzpe, followed 12 hours later by a placebo. RESULTS: Perfect-use failure rates were low in all groups and did not differ in a statistically significant way (standard Yuzpe 2.0% [n = 589], norethindrone-ethinyl estradiol 2.7% [n = 547], single dose of Yuzpe 2.9% [n = 546]). Typical-use failure rates were slightly higher but similarly did not differ significantly. Side effects were similar across groups, except that women taking the single dose reported half the vomiting. Taking the pills with food did not seem to reduce nausea or vomiting, and the pills were not more effective when started sooner after unprotected intercourse. CONCLUSION: Oral contraceptives containing norethindrone-ethinyl estradiol work approximately as well for emergency contraception as levonorgestrel-ethinyl estradiol formulations and should be offered when first-line therapies are not available.

Adolescent↗

PubMed2002

Evaluation of an emergency contraception introduction project in Kenya.

The Consortium for Emergency Contraception introduced Postinor-2, a progestin-only EC product, into Kenya as part of its work to expand access to EC in developing countries. Introduction activities included registering Postinor-2, training providers, and developing provider and client materials. We surveyed family planning clients and providers to assess the impact of these activities. Knowledge of EC among clients and providers improved between the baseline and evaluation surveys. More women and providers had heard of EC and more providers were distributing it. Support for access to EC in Kenya also improved. The results indicate, though, that further information is needed. Only one-fifth of women at the evaluation had heard of EC and almost half of the women expressed concerns about EC at baseline and evaluation. More research and experience using novel ways of informing women about EC in Africa is needed, and information needs to address women's concerns.

Ambulatory Care Facilities↗

PubMed2002

Misoprostol for women's health: a review.

OBJECTIVE: To review published literature on misoprostol for women's health indications to provide a synthesis of available information and highlight areas in need of additional research. DATA SOURCES: Studies were identified through searches of medical literature databases including MEDLINE, Cochrane Database, and Popline, in addition to a review of references from identified articles. STUDY SELECTION: We included all studies reported in English and published before March 31, 2001, which evaluated the efficacy of misoprostol alone for labor and delivery, evacuation of the uterus after pregnancy failure and induced abortion. Studies were not excluded based on quality or sample size. TABULATION, INTEGRATION, AND RESULTS: Misoprostol shows promise for all of the women's health indications addressed. Currently available data, though, are often hard to interpret because of variations in regimen, dose, and outcome measures. The low cost, ease of administration and storage, and widespread availability of misoprostol make it particularly appealing for developing countries. Because many of the women's health problems for which misoprostol could be prescribed currently cause significant mortality and morbidity, increased access to and information on use of misoprostol could help improve women's health especially where these problems are most severe. CONCLUSION: Further research is needed to identify optimal regimens for misoprostol for obstetric and gynecologic health indications. Registering misoprostol with national drug regulatory authorities for any of several women's health indications could help increase access to and safe use of this drug. Provider training would be a logical subsequent step.

Abortifacient Agents↗

PubMed2002

Differences between emergency contraception users in the United States and the United Kingdom.

OBJECTIVES: to characterize emergency contraception (EC) users and clinical trial participants in the United States and the United Kingdom, comparing previous EC use and awareness, contraceptive history, and experience with EC. METHODS: We collected data from all EC seekers (n=5383) at 1 US and 2 UK clinics (9/97-8/98). We also collected detailed information from women (n=2157) enrolling in an EC trial at the first 3 clinics and 2 additional UK sites (9/97-2/00). RESULTS: More US (16%) than UK (4%) women reported additional acts (other than in the last 5 days) of unprotected sex during the cycle in which they sought EC. Fifty-eight percent of UK trial participants had used EC previously compared to 18% in the United States. Most participants in both groups used contraception regularly and reported needing EC because of condom breaks (67% and 56%). More UK than US participants used an ongoing method of contraception (38% v 28%). US women reported more side effects at follow-up than UK women did (76% v 59%), although similar proportions would take EC again or recommend it. CONCLUSIONS: US and UK women in our trial experienced different side effects. Researchers should use caution when presenting aggregate results from international multicenter trials. In addition, readers should be aware that such aggregate results might mask important geographical differences. More research on experience with EC and barriers to contraceptive use in the United States is needed.

Adolescent↗