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Biomedical subjects

Philip D Darney

Publications and source records attributed to Philip D Darney.

At least 19 recordsLinked to original sources

Risk factors associated with presenting for abortion in the second trimester.

OBJECTIVE: To determine factors associated with delay of induced abortion into the second trimester of pregnancy. METHODS: Using audio computer-assisted self-interviewing, 398 women from 5 to 23 weeks of gestation at an urban hospital described steps and reasons that could have led to a delayed abortion. Multivariable logistic regression identified independent contributors to delay. RESULTS: Half of the 70-day difference between the average gestational durations in first- and second-trimester abortions is due to later suspicion of pregnancy and administration of a pregnancy test. Delays in suspecting and testing for pregnancy cumulatively caused 58% of second-trimester patients to miss the opportunity to have a first-trimester abortion. Women presenting in the second trimester experienced more delaying factors (3.2 versus 2.0, P < .001), with logistical delays occurring more frequently for these women (63.3% versus 30.4%, P < .001). Factors associated with second-trimester abortion in logistic regression were prior second-trimester abortion, delay in obtaining state insurance, difficulty locating a provider, initial referral elsewhere, and uncertainty about last menstrual period. Factors associated with decreased likelihood of second-trimester abortion were presence of nausea or vomiting, prior abortion, and contraception use. CONCLUSION: Abortion delay results from myriad factors, many of them logistical, such as inappropriate or delayed referrals and delays in obtaining public insurance. Public health interventions could promote earlier recognition of pregnancy, more timely referrals, more easily obtainable public funding, and improved abortion access for indigent women. However, accessible second-trimester abortion services will remain necessary for the women who present late due to delayed recognition of and testing for pregnancy. LEVEL OF EVIDENCE: II-2.

Abortion, Induced↗

Misoprostol administered by epithelial routes: Drug absorption and uterine response.

OBJECTIVE: To quantify and compare serum levels and uterine effects following vaginal (dry), vaginal (moistened), buccal, and rectal misoprostol administration. METHODS: Forty women seeking elective abortion between 6 and 12 6/7 weeks were randomly assigned to receive 400 mug of misoprostol by one of four routes. A 2.5-mm pressure monitoring catheter was placed through the cervix to the uterine fundus to record uterine tone and activity during the 5-hour observation period. Serum levels of misoprostol acid were measured at 15 and 30 minutes, then every 30 minutes. RESULTS: The four groups were similar in age, race or ethnicity, body mass index, parity, and gestation. Serum levels after vaginal, vaginal moistened and buccal administration rose gradually, peaked between 15 and 120 minutes and fell slowly. Vaginal and vaginal moistened routes produced higher peak serum levels than buccal and rectal (445.9 and 427.1 compared with 264.8 and 202.2 pg/mL; P = .03) and higher serum concentration area under the curve at 5 hours (1,025.0 and 1279.4 compared with 519.6 and 312.5 pg-hr/mL; P < .001). Uterine tone and activity, however, were similar for buccal and the two vaginal routes. After rectal administration, serum levels peaked earlier (P < .001) then dropped more abruptly, and peak uterine tone (P < .001) and total activity (P = .04) were lower than after the other routes. CONCLUSION: Although serum levels were lower for buccal compared with the vaginal routes, the three routes produced similar uterine tone and activity. Rectal administration produced lower uterine tone and activity. Vaginal serum levels were two to three and a half times higher than those observed in prior misoprostol pharmacokinetic studies.

Abortifacient Agents, Nonsteroidal↗

Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial.

CONTEXT: It is estimated that half of unintended pregnancies could be averted if emergency contraception (EC) were easily accessible and used. OBJECTIVE: To evaluate the effect of direct access to EC through pharmacies and advance provision on reproductive health outcomes. DESIGN, SETTING, AND PARTICIPANTS: A randomized, single-blind, controlled trial (July 2001-June 2003) of 2117 women, ages 15 to 24 years, attending 4 California clinics providing family planning services, who were not desiring pregnancy, using long-term hormonal contraception or requesting EC. INTERVENTION: Participants were assigned to 1 of the following groups: (1) pharmacy access to EC; (2) advance provision of 3 packs of levonorgestrel EC; or (3) clinic access (control). MAIN OUTCOME MEASURES: Primary outcomes were use of EC, pregnancies, and sexually transmitted infections (STIs) assessed at 6 months; secondary outcomes were changes in contraceptive and condom use and sexual behavior. RESULTS: Women in the pharmacy access group were no more likely to use EC (24.2%) than controls (21.0%) (P = .25). Women in the advance provision group (37.4%) were almost twice as likely to use EC than controls (21.0%) (P<.001) even though the frequency of unprotected intercourse was similar (39.8% vs 41.0%, respectively, P = .46). Only half (46.7%) of study participants who had unprotected intercourse used EC over the study period. Eight percent of participants became pregnant and 12% acquired an STI; compared with controls, women in the pharmacy access and advance provision groups did not experience a significant reduction in pregnancy rate (pharmacy access group: adjusted odds ratio [OR], 0.98; 95% confidence interval [CI], 0.58-1.64; P = .93; advance provision group: OR, 1.10; 95% CI, 0.66-1.84, P = .71) or increase in STIs (pharmacy access group: adjusted OR, 1.08, 95% CI, 0.71-1.63, P = .73; advance provision group: OR, 0.94, 95% CI, 0.62-1.44, P = .79). There were no differences in patterns of contraceptive or condom use or sexual behaviors by study group. CONCLUSIONS: While removing the requirement to go through pharmacists or clinics to obtain EC increases use, the public health impact may be negligible because of high rates of unprotected intercourse and relative underutilization of the method. Given that there is clear evidence that neither pharmacy access nor advance provision compromises contraceptive or sexual behavior, it seems unreasonable to restrict access to EC to clinics.

Adolescent↗

Improving the accuracy of fetal foot length to confirm gestational duration.

OBJECTIVE: To establish normative fetal foot length ranges using last menstrual period (LMP) and ultrasound dating by biparietal diameter and to examine variations in these ranges by ethnicity. METHODS: A consecutive series of 1,099 eligible subjects receiving abortions had fetal foot lengths measured directly. Models of fetal foot length were developed by using assessment of gestational duration by LMP alone, ultrasonography alone, and "best estimate" (LMP confirmed by ultrasonography). RESULTS: The full sample model using ultrasound dating (n = 1,099) yielded the following equation: foot length = -30.3 + days of gestation x 0.458 (R(2) of 0.92). Regression by LMP-determined gestational duration by using the "best estimate" sample (n = 491) provided an almost identical equation (foot length = -29.8 + days of gestation x 0.45) and a similar R(2) value of 0.87, although the standard errors were larger. Gestational duration by ultrasonography alone produced a better model fit than duration by LMP alone. Regressions by ethnicity were not significantly different compared with the simple regression, regardless of method used to determine gestational duration. CONCLUSION: A reconsideration of fetal foot length measurements to confirm gestational duration is important. More accurate tables of these measurements allow for greater precision in correlating gestational duration and foot length. Fetal foot length tables using ultrasonographically confirmed gestational duration and current statistical standards should replace tables currently used. Biparietal diameter as a single measurement provides adequate estimation of gestational duration in the second trimester for pregnancy termination, proving more reliable than LMP dating. LEVEL OF EVIDENCE: II-2.

Adolescent↗

Misoprostol compared with laminaria before early second-trimester surgical abortion: a randomized trial.

OBJECTIVE: To compare the efficacy and acceptability of same-day misoprostol and overnight laminaria for cervical ripening before early second-trimester surgical abortion. METHODS: We performed a randomized, double-blinded, controlled trial comparing 400 microg of vaginal misoprostol, given 3-4 hours preoperatively, with overnight laminaria before early second-trimester surgical abortion among women at 13.0-16.0 weeks of gestation (n = 84). The primary outcome was procedure time, and the sample size was based on 95% power to detect a difference of 4.5 minutes between groups. Secondary outcomes included completion of the procedure on the first attempt, procedural difficulty, and patients' pain scores and preferences. RESULTS: The average gestational duration was 14 weeks 6 days. Procedures performed after laminaria were significantly faster than those after misoprostol (median 3.4 versus 7.2 minutes, respectively, P = .01). Laminaria patients had significantly greater dilation than misoprostol patients at abortion (mean 43 versus 33 French, P < .001), and more misoprostol patients required additional dilation (85% versus 21%, P < .001). Physicians rated 27% of the misoprostol procedures as moderate-markedly difficult versus 5% of laminaria procedures (P = .01). Differences in efficacy were pronounced among nulliparous patients. There were no significant differences in ability to complete the procedure on the first attempt or patients' intraoperative pain scores. More women in the misoprostol group would choose their assigned method again (93% versus 62%, P < .01), and 82% of all subjects preferred a 1-day procedure. CONCLUSION: Early second-trimester abortions take longer and are technically more challenging after cervical ripening with same-day misoprostol than with overnight laminaria, but patients prefer same-day misoprostol.

Abortifacient Agents, Nonsteroidal↗

The effect of increased access to emergency contraception among young adolescents.

OBJECTIVES: The United States Food and Drug Administration cited an absence of data on young adolescents as the reason the emergency contraceptive, Plan B, could not be moved over-the-counter. This study analyzed data on young adolescents with increased access to emergency contraception. METHODS: We conducted an age-stratified analysis with previously published data from a randomized, controlled trial of Plan B with a sample size of 2,117, including 964 adolescents, 90 of whom were aged younger than 16 years. Participants were randomly assigned to nonprescription pharmacy access, advance provision of 3 packs, or clinic access (control). We measured contraceptive and sexual risk behaviors at baseline and 6-month follow-up and tested for pregnancy and sexually transmitted infections. We used contingency table and logistic regression analysis to measure the effect of the intervention on risk behaviors in young adolescents (< 16 years), compared with middle adolescents (16-17 years), older adolescents (18-19 years), and adults (20-24 years). RESULTS: Adolescents aged younger than 16 years behaved no differently in response to increased access to emergency contraception (EC) from the other age groups. As with adults, EC use was greater among adolescents in advance provision than in clinic access (44% compared with 29%; P < or = .001), and other behaviors were unchanged by study arm, including unprotected intercourse, condom use, sexually transmitted infection acquisition, or pregnancy. Additionally, adolescents with increased access to EC did not become more vulnerable to unwanted sexual activity. CONCLUSION: Young adolescents with improved access to EC used the method more frequently when needed, but did not compromise their use of routine contraception nor increase their sexual risk behavior. LEVEL OF EVIDENCE: I.

Adolescent↗

HIV sentinel surveillance among women seeking elective pregnancy termination, San Francisco.

OBJECTIVE: The objective of this study was to measure HIV prevalence, HIV incidence, and risk factors for infection among women seeking elective pregnancy termination in San Francisco. STUDY: The authors conducted a cross-sectional survey comprising a consecutive sample of women seeking elective pregnancy termination in San Francisco's county hospital from August 2002 to July 2003. Demographic and risk behavior information was abstracted from routine clinic records. HIV testing was conducted on blood specimens collected for other purposes after removing identifying information. RESULTS: Based on 11 HIV-positives among 1,992 tested, HIV prevalence among women seeking pregnancy termination was 0.55% (95% confidence interval [CI], 0.28-0.99). One recent HIV seroconversion was detected for an annual incidence of 0.11% per year (95% CI, 0.23-0.88). In addition, risk factors significantly associated with HIV infection included sex with a known HIV-positive man, history of an abnormal Pap smear, history of genital herpes infection, history of trichomoniasis, and age 25 to 29 years. CONCLUSIONS: Women electing pregnancy termination can serve as a sentinel population to track trends in the HIV epidemic. However, barriers remain to wider implementation of the approach as a surveillance tool.

Abortion, Induced↗

Abortion in the United States.

Abortion is an extremely safe and common medical procedure. In the United States, over one million women had an abortion in the year 2000. Advances in early abortion techniques have helped to increase the proportion of early procedures, the safest type. Abortion rates have been declining since the early nineties among adults and adolescents, but rates among poor, minority women remain high. State restrictions to abortion have a larger impact on poor women and young women. Restrictions and regulations have also resulted in the concentration of abortion services in specialized clinics. These clinics are subject to harassment. The expansion of abortion services to more types of providers could increase access, as well as integrate abortion into women's health care.

Abortion, Legal↗

Angiogenic effects of norplant contraception on endometrial histology and uterine bleeding.

Norplant, a sc contraceptive device, releases levonorgestrel in a sustained fashion. Its effectiveness is offset by irregular bleeding patterns. Because vascular endothelial growth factor (VEGF) is stimulated by synthetic progestogens in vitro and in vivo, we postulated that correlations between this angiogenic factor and uterine bleeding patterns might exist. Twenty-eight women who were exposed to Norplant and 13 control women were prospectively followed for 6-8 months. Bleeding diaries were collected, hysteroscopies were performed, endometrial biopsies were obtained for standardized histological evaluation, and VEGF histochemical immunostaining (H)-scores were assigned. Cluster determination-34 (CD34) staining was also performed to quantify the number of endometrial blood vessels per high-power field. Irregular uterine bleeding was common among women using Norplant devices. Endometrial VEGF H-scores were greater in women using Norplant than in control women. New findings of this study show that vessel density did not correlate with epithelial VEGF H-scores but was highly associated with the intensity of stromal and perivascular VEGF. VEGF expression in the latter regions correlated significantly with hysteroscopic abnormalities and irregular bleeding. The expression of this angiogenic protein, particularly in the stromal and perivascular compartments, correlated with microvascular density, hysteroscopically documented hypervascularity, and uterine bleeding profiles. Irregular bleeding with Norplant use appears to reflect paracrine-mediated effects on vascular function by angiogenic factors, such as VEGF.

Adult↗

Recent developments in hormone delivery systems.

Women who want safe, effective contraception have many more options than they did only a few years ago. Each option must be weighed carefully according to the needs and lifestyle of each particular woman. One method that provides long-term convenience with a side-effect profile that is comparable to that of oral contraceptives is the once-a-month injectable contraceptive containing 25 mg medroxyprogesterone acetate and 5 mg estradiol cypionate. Another option is the levonorgestrel-releasing intrauterine contraceptive system that offers pregnancy prevention for 5 years. Finally, hormonal implants that release low doses of progestins have been used for more than 30 years by a total of 10 million women, and easier-to-use implants will soon be available.

Contraceptive Agents, Female↗

Tolerability of levonorgestrel emergency contraception in adolescents.

OBJECTIVE: We evaluated the tolerability of emergency contraception in adolescents. Study design In this descriptive study, 1 0.75 mg levonorgestrel tablet was administered to 52 females aged 13-16 with instructions to take the second tablet 12 hours later (unprotected intercourse was not an entry requirement). Participants kept diaries of side effects and menstrual patterns. We assessed correct use, side effects caused by treatment, and impact on menstrual cycle. RESULTS: Virtually all participants used the drug correctly, with no serious adverse events. Minor expected side effects occurred, including nausea, fatigue, and vomiting. There was no difference in reporting of side effects by age. Adolescents' mean duration of menses was comparable pre- and post-treatment (5.3 vs 5.0 days; P=.146), and onset of menses was within the expected range. Ninety percent of participants reported they would recommend emergency contraception to a friend or relative if needed. CONCLUSION: Adolescents tolerated the medication well, experiencing transient side effects.

Adolescent↗

Contraceptive use and risk of unintended pregnancy in California.

California is home to more than one out of eight American women of reproductive age. Because California has a large, diverse and growing population, national statistics do not necessarily describe the reproductive health of California women. This article presents risk for pregnancy and sexually transmitted infections among women in California based on the California Women's Health Survey. Over 8900 women of reproductive age who participated in this survey between 1998 and 2001 provide estimates of access to care and use of family-planning methods in the state. We find that 49% of the female population aged 18-44 in California is at risk of unintended pregnancy. Nine percent (9%) of women at risk of an unintended pregnancy are not using any method of contraception, primarily for method-related reasons, such as a concern about side effects or a dislike of available contraceptive methods. Among women at risk for unintended pregnancy, we find disparities by race/ethnicity and education in use of contraceptive methods.

Adolescent↗

Manual versus electric vacuum aspiration for early first-trimester abortion: a controlled study of complication rates.

OBJECTIVE: Manual vacuum aspiration is an alternative to electric suction curettage for first-trimester elective abortion. Although many studies have demonstrated that manual vacuum aspiration is safer than sharp curettage for abortion, only a few studies have directly compared it with electric suction curettage. These studies proved the methods to be equally effective and acceptable but were too small to adequately compare safety. We compared immediate complication rates for abortions performed by manual and electric vacuum aspiration. METHODS: We conducted a retrospective cohort analysis of all women undergoing elective abortion at up to 10 weeks' gestation at San Francisco General Hospital over a 3.5-year period. A total of 1726 procedures were included: 1002 manual and 724 electric vacuum aspirations. Clinical data were collected from medical records. Rates of uterine reaspiration and other immediate complications occurring at our institution were compared. RESULTS: We found no difference in the rate of uterine reaspiration after abortions performed with the manual or electric suction device (2.2% versus 1.7%, respectively, P =.43). We had 80% statistical power to detect a 2% difference in uterine reaspiration rates with an microa error of.05. Overall major complication rates were 2.5% with manual and 2.1% with electric suction curettage, P =.56. Multivariable regression analyses controlling for potential confounders showed no difference in uterine reaspiration rates (electric odds ratio [OR] = 0.71, 95% confidence interval [CI] 0.32, 1.6) or overall complications (electric OR = 0.81, 95% CI 0.40, 1.7). CONCLUSION: Manual vacuum aspiration is as safe as electric suction curettage for abortions at up to 10 weeks' gestation. Expanded use in an office setting might increase abortion access.

Abortion, Induced↗

Prostaglandins for first-trimester termination.

Since the 1980s, when mifepristone combined with a prostaglandin was found to be safe and effective for early abortion, many studies have refined the regimens and investigated alternatives such as methotrexate plus misoprostol, and misoprostol alone. Evidence now demonstrates that more than 200 mg of mifepristone provides no additional benefit, that vaginal misoprostol is superior to oral, especially between 7 and 9 weeks' gestation, and that misoprostol may be safely self-administered at home. Buccal and sublingual routes of administration of misoprostol also are promising. Absolute contraindications to medical abortion arise infrequently. Gastrointestinal and other side-effects occur in about one-third of women, primarily after administration of the prostaglandin. Careful assessment before and after medical abortion is essential and can be accomplished in various ways, depending on the skills of the clinician.

Abortifacient Agents, Nonsteroidal↗

The effect of training on the provision of elective abortion: a survey of five residency programs.

OBJECTIVE: We investigated the correlation of residency abortion training and other variables with abortion provision. STUDY DESIGN: We surveyed obstetrician-gynecologists who graduated from five residency programs. Subjects were asked about demographic characteristics, residency abortion training, and abortion provision. We used a logistic regression model that included all variables that were correlated significantly with abortion provision in univariate analyses. RESULTS: Of 161 physicians (61%) who responded, 131 physicians (83%) participated in abortion training. Seventy-six physicians (47%) provided abortions currently, and 95 physicians (58%) had provided abortions at some time since residency. Three variables were independently, positively correlated with abortion provision: the number of abortions that were performed during residency, the gestational age limit of abortion training, and urban practice. Negatively correlated with provision were membership in a restrictive practice and training outside the teaching hospital. CONCLUSION: Variables that were indicative of more extensive residency abortion training were associated positively with the current provision of abortion.

Abortion, Induced↗