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Biomedical subjects

Carolyn Westhoff

Publications and source records attributed to Carolyn Westhoff.

At least 19 recordsLinked to original sources
PubMed2007

Depo Now: preventing unintended pregnancies among adolescents and young adults.

PURPOSE: We compared the immediate administration of DMPA (Depo Now) to the immediate use of short-term hormonal methods that served as a "bridge method" until later DMPA initiation. We examined whether Depo Now, as compared to initiating with a bridge method (pills, transdermal patch, or vaginal ring), resulted in greater DMPA continuation at six months. METHODS: Young women aged 14 to 26 years seeking to use DMPA were randomized (nonblinded) after meeting eligibility criteria to either the Depo Now (n = 101) or bridge method (n = 232) group. Depo Now subjects received their first injection of DMPA at the conclusion of their first visit provided each was medically suitable and had a negative urine pregnancy test regardless of menstrual cycle day. Those assigned to the bridge method group were allowed to choose their starting contraceptive method and it was provided at the first visit. All subjects were told to return to the clinic in 21 days to repeat the urine pregnancy test, and among those who were assigned to use a bridge method, to receive their first injection of DMPA. All subjects were followed to their third injection, or about 6 months later. RESULTS: Those randomized to a bridge method were 1.8 (1.1, 2.9) times more likely than Depo Now subjects to return for their 21-day repeat pregnancy test, but only 55% (n = 125) of these young women actually received their first DMPA injection. Continuation rates at the third injection were 29.7% (n = 30) for those in the Depo Now group and 21.1% (n = 49) for those assigned to the bridge method (p = .09). Three factors were significantly associated with adherence to the third injection: randomized to Depo Now group, knowing more women who use DMPA, and returning to clinic for the 21-day repeat pregnancy test visit. Finally, 28 pregnancies were diagnosed during the study period, and those in the bridge method group were almost 4.0 (1.2, 13.4) times more likely to be diagnosed with a pregnancy than those in the Depo Now group. CONCLUSIONS: Immediate administration of DMPA is associated with improved adherence to DMPA continuation and fewer pregnancies.

Adolescent↗
PubMed2006

Combined hormonal contraceptive trials: variable data collection and bleeding assessment methodologies influence study outcomes and physician perception.

Initially approved for use in the United States nearly 50 years ago, oral hormonal contraceptives containing both estrogen and progestin have undergone steady improvements in safety and convenience. Concurrent with improvements in safety associated with decreasing doses of both steroids, there has been an increased incidence of unscheduled bleeding and spotting. There exist no standards regarding data collection techniques and methods, and reporting and analysis of bleeding and spotting events during combined hormonal contraceptive (CHC) trials. For the regulatory review of hormonal contraceptives, data regarding the incidence of bleeding and spotting events are not included in either of the traditional categories of efficacy and safety. Standardization of methods for collecting and analyzing data about cycle control in all clinical trials of CHCs is long overdue. Until such standards are developed and implemented, clinicians need to familiarize themselves with the techniques used in each study in order to provide correct information to their patients about the frequency of bleeding and spotting associated with different formulations and delivery systems.

Female↗
PubMed2006

Recommendations for standardization of data collection and analysis of bleeding in combined hormone contraceptive trials.

This is the second of a two-article series describing the outcomes of the Hormonal Contraceptives Trial Methodology Consensus Conference held in Philadelphia, PA, on September 23, 2005. The first manuscript, "Hormonal Contraceptive Trials: Variable Data Collection and Bleeding Assessment Methodologies Influence Study Outcome and Physician Perception," provided a description of methodologies applied in the US Food and Drug Administration medical officer's review of clinical trial data as contained in the Summary Basis of Approvals of New Drug Applications, results of the review and general conclusions. This manuscript provides recommendations regarding best practices in trial design, data collection and analysis regarding bleeding data in combined hormone contraception trials.

Contraceptives, Oral, Combined↗
PubMed2006

Acceptability and satisfaction using Quick Start with the contraceptive vaginal ring versus an oral contraceptive.

BACKGROUND: Many women discontinue their use of hormonal contraception, and even those who continue so may have difficulty using oral contraceptive pills consistently. New delivery systems, including the vaginal ring, may be easier to use, but user acceptability and satisfaction with these new methods may be affected by women's experience with their bodies. MATERIALS AND METHODS: Data for this study were collected as part of a randomized clinical trial on 201 women comparing immediate start of vaginal ring use with immediate start of low-dose oral contraceptive use. We assessed user satisfaction and method continuation 3 months after ring or pill initiation. RESULTS: At 3 months, 174 of 201 subjects (87%) had follow-up interviews. Among the 174 study participants with follow-up data, 61% of ring subjects and 34% of pill subjects were very satisfied with their methods (p=.003). For posttrial contraception, 79% of ring subjects chose to continue with the ring whereas 59% of pill subjects chose to continue with the pill (p<.001). Women who reported greater comfort in touching their genitals, greater frequency of masturbation, more comfort with intercourse and past use of vaginal contraceptives and products were not more likely than others to be satisfied with the ring or to continue using it for birth control. CONCLUSION: Women who were allocated to vaginal ring use, regardless of their baseline characteristics or behavior, were likely to be highly satisfied with the method and to continue its use.

Adult↗
PubMed2006

Self-treatment patterns among adolescent girls with dysmenorrhea.

STUDY OBJECTIVE: To describe both non-pharmacologic and pharmacologic treatments used by adolescents with dysmenorrhea. DESIGN: Cross-sectional study. SETTING: Urban academic medical center. PARTICIPANTS: Healthy adolescents aged 19 years or younger (n = 76) with moderate to severe primary dysmenorrhea were included; those using hormonal contraception were excluded. INTERVENTION: We collected baseline data via interview from adolescent girls at enrollment in a clinical trial of oral contraceptives versus placebo for primary dysmenorrhea. The interview data, collected prior to any intervention, included information on demographics, dysmenorrhea duration and severity, and self-treatment. We used the validated pain subscale of the Moos Menstrual Distress Questionnaire and a 0-10 pain rating scale to estimate pain severity. MAIN OUTCOME MEASURE: Investigator-administered questionnaire. RESULTS: Adolescents' mean age was 16.8 years (SD = 2). Similar proportions described themselves as white (26%), black (30%) or Hispanic (28%). Dysmenorrhea was moderate in 42%, severe in 58%, associated with nausea in 55%, and vomiting in 24%. Of those attending school (n = 66), 46% reported missing one or more days monthly due to dysmenorrhea. Nearly all discussed their pain with someone; however, a minority sought formal medical care. All used nonpharmacological remedies such as sleeping and heat application. Nearly all used at least one medication, 31% reported using two, and 15% used three medications (not concurrently). Many participants reported using medication at sub-therapeutic doses for pain. CONCLUSIONS: Adolescents with moderate and severe dysmenorrhea reported high morbidity. Girls used numerous non-pharmacologic remedies as well as medications for pain but infrequently accessed formal medical care. Medication dosing was often sub-therapeutic.

Absenteeism↗
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↗
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

Measured and reported weight change for women using a vaginal contraceptive ring vs. a low-dose oral contraceptive.

BACKGROUND: Women often stop hormonal contraception because of perceived weight change. We conducted a randomized trial comparing the contraceptive vaginal ring to a low-dose oral contraceptive (OC). We examined the difference between women's reported and measured baseline weights and looked at factors affecting perceived weight change. METHODS: We randomized 201 participants to either the vaginal ring or an OC for three cycles. We weighed participants upon enrollment (n=194) and at exit (n=167), using the same instrument for all measurements. Participants also provided self-reported height and their reactions to perceived weight changes. RESULTS: Baseline weight and body mass index were similar for both groups (mean weight=145.9 lb). Measured weight was, on average, 4.4 lb more than reported weight; this difference was greater in overweight and obese participants. Participants gained an average of 2.8 lb over 3 months; this gain did not differ between groups or by baseline weight. Subjects who reported a "bad change" in weight at exit (n=34) gained an average of 4.4 lb, whereas those who reported "no change" (n=112) gained 2.2 lb and those who reported a "good change" (n=14) gained 3.3 lb. CONCLUSION: Participants underreported their weight, and this difference was greater for heavier women. There was little weight change for the women in our study. Participants' opinions about weight change were not correlated with measured weight changes.

Administration, Intravaginal↗
PubMed2005

Cost-effectiveness and contraceptive effectiveness of the transdermal contraceptive patch.

OBJECTIVE: The purpose of this study was to examine implications of increased perfect use on the cost-effectiveness of the contraceptive patch compared with combination oral contraceptives (COCs). STUDY DESIGN: This study compared the patch with low-estrogen-dose COCs. It assumes that the risks of developing a medical condition during use are the same for both the patch and COCs. Differences in net cost and pregnancies avoided during use were modeled. With the use of a pharmacoeconomic model, both methods were compared with a hypothetical reference case of contraception nonuse. The base-case model considered women, ages 15 to 50, in average health in a long-term, mutually monogamous, heterosexual relationship. RESULTS: The base-case analysis showed that use of the patch resulted in a savings of 249 US dollars and 0.03 pregnancies per woman over 2 years compared with COCs. CONCLUSION: This analysis demonstrated that patch use would be cost saving compared with COC use, resulting in a net avoidance of pregnancy for this population. The cost savings are attributed to reduced costs of pregnancy.

Administration, Cutaneous↗
PubMed2005

A prospective study of immediate initiation of depo medroxyprogesterone acetate contraceptive injection.

Traditional protocols for depo medroxyprogesterone acetate (DMPA) initiation mandate that women start the method during the first 5-7 days of the menstrual cycle. Women who do not have their initial clinic visit during this time period are generally instructed to return to clinic during menses to begin DMPA, which often leaves them insufficiently protected from pregnancy. An alternative approach is to give women the injection immediately during the clinic visit, regardless of menstrual cycle day. In this prospective study, we evaluated a protocol for immediate DMPA initiation among 149 women who presented on cycle day 8 or later. Ninety-two percent (n = 137) of subjects returned for a follow-up pregnancy test, but half of all subjects required multiple reminders to return for the visit. There were three pregnancies. Forty-seven percent (n = 70) continued to a second DMPA injection or another contraceptive method within 14 weeks of their initial clinic visit. Factors associated with returning for repeat injection included satisfaction with DMPA, older age and finding it easy to return for the follow-up pregnancy test visit.

Adult↗
PubMed2005

Are germinal inclusion cysts markers of ovulation?

OBJECTIVES: Germinal inclusion cysts (GICs) of the ovary are possible precursor lesions for epithelial ovarian cancer. These cysts have been postulated to form as stigmata of ovulation. It is known that oral contraceptives, breastfeeding, and pregnancy, which decrease lifetime ovulations, confer protection against epithelial ovarian cancer. This study was undertaken to determine if ovarian density of epithelial inclusion cysts corresponds to a woman's frequency of ovulation. METHODS: One hundred two cases of women undergoing incidental oophorectomy at the time of surgery for benign gynecological conditions were interviewed for information relating to ovulation. Review of multiple sections of ovarian tissue was performed to count numbers of GICs. RESULTS: There was a modest correlation between the average number of germinal inclusion cysts and ovulatory age (Spearman's rho = 0.2, P = 0.06). There were fewer GICs in current smokers and ever-users of oral contraceptives; however these associations were not significant (P > 0.1). CONCLUSIONS: This study showed increased numbers of GICs in women of greater ovulatory age, and those who were not current smokers or ever used oral contraceptives. This provides some evidence that GICs may be caused by ovulation. The small number of subjects limited our ability to evaluate associations.

Adult↗
PubMed2005

Bleeding patterns after immediate initiation of an oral compared with a vaginal hormonal contraceptive.

OBJECTIVE: This study compared 84-day bleeding patterns after immediate initiation of a triphasic oral contraceptive with a 25-mug daily dose of ethinyl estradiol (E2) compared with the contraceptive vaginal ring, which has a 15-mug daily dose of ethinyl E2. METHODS: This was an open-label controlled trial. We randomly assigned 201 women to immediate start of a contraceptive pill or immediate start of the ring in a 1:1 allocation ratio. Our primary outcome was difference in mean bleeding-spotting days per woman according to treatment assignment. Secondary outcomes were differences in World Health Organization-defined menstrual indices, differences in perceived bleeding changes, and differences in bleeding according to cycle day at the start of method. RESULTS: The mean bleeding-spotting days in the 84-day reference period for all subjects was 19.2 days (17.0 days for ring users and 21.4 days for pill users, mean difference 4.4 days). Using the World Health Organization menstrual indices, the ring users experienced fewer days or episodes of bleeding-spotting and shorter intervals. Among ring users, no baseline characteristics were associated with bleeding outcomes. Older nulliparous pill users, however, reported more bleeding-spotting days. Significantly more ring users reported a decrease in duration of bleeding compared with pill users (P < .01). We found no significant differences in bleeding patterns based on analysis of cycle day at study enrollment. CONCLUSION: Our study shows advantageous bleeding patterns for subjects using the contraceptive vaginal ring. It also confirms our previous findings that immediate start of hormonal contraception is an acceptable alternative to waiting for menses. LEVEL OF EVIDENCE: II-1.

Adult↗
PubMed2005

Oral contraceptives for dysmenorrhea in adolescent girls: a randomized trial.

OBJECTIVE: To assess whether a low-dose oral contraceptive (OC) is more effective than placebo treatment for dysmenorrhea pain in adolescents. METHODS: This was a randomized, double-blind, placebo-controlled clinical trial of 76 healthy adolescents aged 19 years or younger reporting moderate or severe dysmenorrhea. Subjects were randomly allocated to receive either an OC (ethinyl estradiol [E2] 20 microg and levonorgestrel 100 microg) or a matching placebo for 3 months. Participants used their usual pain medications as needed during the trial. The main outcome measure was score on the Moos Menstrual Distress Questionnaire (pain subscale) for the third menstrual cycle on treatment. Secondary outcomes included pain intensity (rated 0 to 10), days of any pain, days of severe pain, hours of pain on worst day, and use of pain medications. RESULTS: The mean Moos Menstrual Distress Questionnaire pain score was lower (less pain) in the OC group than the placebo group (3.1, standard deviation 3.2 compared with 5.8, standard deviation 4.5, P = .004, 95% confidence interval for the difference between means 0.88-4.53). By cycle 3, OC users rated their worst pain as less (mean pain rating 3.7 compared with 5.4, P = .02) and used fewer pain medications than placebo users (mean pain pills used 1.3 compared with 3.7, P = .05). By cycle 3, OC users reported fewer days of any pain, fewer days of severe pain, and fewer hours of pain on the worst pain day than placebo users; however, these differences did not reach statistical significance. CONCLUSIONS: Among adolescents, a low-dose oral contraceptive relieved dysmenorrhea-associated pain more effectively than placebo. LEVEL OF EVIDENCE: I.

Adolescent↗
PubMed2004

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↗
PubMed2004

Immediate monthly combination contraception to facilitate initiation of the depot medroxyprogesterone acetate contraceptive injection.

Conventional clinical protocols specify that women initiate depot medroxyprogesterone acetate (DMPA) within 7 days of the onset of menses, and product labeling specifies initiation within 5 days. Women outside of this window should wait until next menses to begin, often leaving them with inadequate interim contraceptive protection. An alternative is for women to initiate monthly hormonal contraception immediately, as a bridge to DMPA, with a scheduled follow-up appointment about 4 weeks later. We evaluated bridge preferences and DMPA initiation among 150 women requesting DMPA who were ineligible for their first injection at the time of clinic visit due to menstrual cycle day. Ninety-eight percent (n = 147) rejected the standard protocol of waiting with condoms or abstinence in favor of a hormonal bridge method. Ninety-seven percent follow-up (n = 146) showed that 86% were satisfied with their bridge method. There were no posttreatment pregnancies, and 55% (n = 81) of participants had initiated DMPA or another long-term contraceptive within 4 weeks of their initial clinic presentation.

Adolescent↗
PubMed2003

Quality of life following early medical or surgical abortion.

Short-term quality of life following abortion is poorly characterized. We conducted a prospective cohort study to evaluate 97 U.S. women who selected either medical abortion with mifepristone and misoprostol or surgical abortion up to 9 weeks gestation in a private-practice setting. Women choosing medical abortion and those choosing surgical abortion with local anesthesia were similar on most baseline characteristics. Eighty-five participants completed a standardized quality of life assessments three times over 1 month. The 30-item questionnaire yielded scores for global health, emotional, social, cognitive and physical functioning and for specific symptom scales. At baseline, participants reported many symptoms and functional limitations during the previous week. Subjects in both treatment groups experienced clinically and statistically significant improvements on all scales at follow-up. Surgical abortion patients had worse scores on three of five function scales and several symptom scales at baseline compared to medical abortion patients. Differences in baseline scores between the medical and surgical abortion patients disappeared during follow-up. A surprising finding was that partner knowledge of the pregnancy at the time the abortion appointment was made was associated with significantly worse scores on most of the function and symptom scales. These results provide substantial reassurance that women undergoing abortion experience a marked improvement in their quality of life after the abortion. Women choosing medical or surgical abortion report very similar quality of life improvements.

Abortifacient Agents↗