Phase 2a study assessing colonization efficiency, safety, and acceptability of Lactobacillus crispatus CTV-05 in women with bacterial vaginosis.

BACKGROUND: Bacterial vaginosis (BV) is a common vaginal infection caused by a lack of endogenous lactobacilli and overgrowth of pathogens that frequently recurs following antibiotic treatment. METHODS: A phase 2a study assessed colonization efficiency, safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) administered by a vaginal applicator. Twenty-four women with BV were randomized in a 3:1 ratio of active product to placebo. Participants used LACTIN-V at 2 × 10 colony-forming units (cfu)/dose or placebo for 5 initial consecutive days, followed by a weekly application over 2 weeks. They returned for follow-up on Days 10 and 28. RESULTS: Sixty-one percent of the 18 women randomized to the LACTIN-V group were colonized with L. crispatus CTV-05 at Day 10 or Day 28. Among LACTIN-V users with complete adherence to the study regimen, 78% were colonized at Day 10 or Day 28. Of the 120 adverse events (AEs) that occurred, 108 (90%) and 12 (10%) were of mild and moderate severity, respectively. AEs were evenly distributed between the LACTIN-V and placebo group. Of the total AEs, 93 (78%) were genitourinary in origin. The most common genitourinary AEs included vaginal discharge (46%), abdominal pain (46%), dysuria (21%), pollakiuria (21%), vaginal odor (21%), and genital pruritus (17%). No grade 3 or 4 AEs or serious AEs occurred and no deep epithelial disruption was seen during colposcopic evaluation. The product was well tolerated and accepted. CONCLUSIONS: LACTIN-V colonized well, and was safe and acceptable in women treated for BV.

Impact of immediate postabortal insertion of intrauterine contraception on repeat abortion.

BACKGROUND: Of the 1.3 million abortions performed annually in the United States, approximately half are repeat procedures. Immediate postabortal intrauterine device (IUD) insertion is a safe, effective, practical and underutilized intervention that we hypothesize will significantly decrease repeat unintended pregnancy and abortion. STUDY DESIGN: All women receiving immediate postabortal IUD insertion in eight clinics of a Northern California Planned Parenthood agency during a 3-year period comprise the IUD cohort. We selected a cohort of controls receiving abortions but choosing other, non-IUD contraception on the day of the abortion visit in a 2:1 ratio matched by date of abortion. We obtained follow-up data on repeat abortions within the agency for both cohorts through 14 months after the 3-year period. We evaluated differences in repeat abortion between cohorts. All analyses were intent-to-treat. RESULTS: Women who received an immediate postabortal IUD had a lower rate of repeat abortions than controls (p<.001). Women who received a postabortal IUD had 34.6 abortions per 1000 woman-years of follow-up compared to 91.3 for the control group. The hazard ratio for repeat abortion was 0.38 [95% confidence interval (CI), 0.27-0.53] for women receiving a postabortal IUD compared to controls. When adjusted for age, race/ethnicity, marital status, and family size, the hazard ratio was 0.37 (95% CI, 0.26-0.52). CONCLUSION: Immediate postabortal intrauterine contraception has the potential to significantly reduce repeat abortion.

Increasing intrauterine contraception use by reducing barriers to post-abortal and interval insertion.

BACKGROUND: We hypothesize that barriers to IUD insertion are central to low utilization in the USA. This study evaluates methods to minimize barriers, including post-abortal insertion, staff training and simplified screening. STUDY DESIGN: We obtained data on IUD utilization during three study periods: a control period (Period 1), a period after initiating post-abortal insertion and staff training (Period 2), and a period with these interventions plus simplified screening for interval insertions (Period 3). We evaluated IUD utilization, associated complications and utilization at a similar local agency in which the interventions were not implemented. RESULTS: We inserted 2172 IUDs during the study, including 1493 interval and 679 post-abortal insertions. In the control period, there were 28 monthly IUD insertions on average, compared to 71 (a 151% increase) and 122 (a 334% increase) in Periods 2 and 3, respectively. IUD utilization at the nearby agency remained relatively constant. Complications remained low. CONCLUSIONS: IUD utilization can be substantially increased through relatively simple, low-cost interventions, with significant potential to reduce unintended pregnancy.

Treating incomplete abortion in El Salvador: cost savings with manual vacuum aspiration.

When manual vacuum aspiration (MVA) was introduced to treat incomplete abortion at a regional training hospital in El Salvador, this study evaluated the impact of replacing sharp curettage with MVA. Hospital cost, length of hospital stay, complication rates and postabortion contraceptive acceptance were compared in a prospective, nonrandomized, controlled study of 154 women assigned to either traditional sharp curettage services or MVA services plus contraceptive counseling. Assignment depended on availability of trained providers. Compared to sharp curettage, use of MVA and associated changes in protocol led to a significant cost savings of 13% and shorter hospital stay of 28%. Dedicated family-planning counseling resulted in a threefold higher rate of contraceptive acceptance. Although the difference in cost was significant, much higher savings could be realized if minimal postoperative stays were implemented for both procedures. Barriers to early discharge include patient expectations, physician attitudes and training and hospital systems administration.

Cost savings of manual vacuum aspiration for endometrial sampling in El Salvador.

Despite the existence of less costly and less invasive techniques to evaluate abnormal uterine bleeding, sharp curettage continues to be the most common form of endometrial sampling in the less developed world. Because manual vacuum aspiration (MVA) equipment is often associated with abortion care in countries where abortion is illegal, many practitioners have been slow to incorporate its use for other gynecological conditions. In this study, MVA was introduced in a large teaching hospital in El Salvador as an alternative for patients with abnormal uterine bleeding. Hospital cost, length of stay and complication rates were compared in a prospective, nonrandomized controlled study of 163 patients assigned to either traditional sharp curettage or MVA services. Patients were assigned to each group depending on the availability of trained providers. Methodologies for cost-savings analysis were modified to obtain more precise cost estimates. Use of MVA was associated with a significant cost savings of 11% and a hospital stay that was 27% shorter as compared to sharp curettage. Cost savings could be much higher if MVA was institutionalized as an ambulatory procedure with minimal or no preoperative evaluation and postoperative stay.

One-year contraceptive continuation and pregnancy in adolescent girls and women initiating hormonal contraceptives.

OBJECTIVE: To assess contraceptive discontinuation, switching, factors associated with method discontinuation, and pregnancy among women initiating hormonal contraceptives. METHODS: This was a 12-month longitudinal cohort study of adolescent girls and women (n=1,387) aged 15 to 24 years attending public family planning clinics who did not desire pregnancy for at least 1 year and selected to initiate the patch, ring, depot medroxyprogesterone acetate, or pills. Participants completed follow-up assessments at 3, 6, and 12 months after baseline. Life table analysis was used to estimate survival rates for contraceptive continuation. Cox proportional hazards models were used to estimate factors associated with method discontinuation. RESULTS: The continuation rate (per 100 person-years) at 12 months was low for all methods; however, it was lowest for patch and depot medroxyprogesterone acetate initiators, 10.9 and 12.1 per 100 person years, respectively (P≤.003); continuation among ring initiators was comparable to pill initiators, 29.4 and 32.7 per 100 person-years, respectively (P=.06). Discontinuation was independently associated with method initiated and younger age. The only factors associated with lower risk of discontinuation were greater intent to use the method and being in school or working. The pregnancy rate (per 100 person-years) was highest for patch and ring initiators (30.1 and 30.5) and comparable for pill and depot medroxyprogesterone acetate initiators (16.5 and 16.1; P<.001). CONCLUSION: The patch and the ring may not be better options than the pill or depot medroxyprogesterone acetate for women at high risk for unintended pregnancy. This study highlights the need for counseling interventions to improve contraceptive continuation, education about longer-acting methods, and developing new contraceptives that women may be more likely to continue. LEVEL OF EVIDENCE: II.

Hormonal contraceptive method choice among young, low-income women: how important is the provider?

OBJECTIVES: Several new methods are available, but we know little about successful integration of contraceptive technologies into services. We investigated provider factors associated with the initiation of new hormonal methods among women at high risk of unintended pregnancy. METHODS: This cohort study enrolled 1387 women aged 15-24 starting hormonal contraception (vaginal ring, transdermal patch, oral contraceptive, or injectable) at four family planning clinics in low-income communities. We measured provider factors associated with method choice, using multinomial logistic regression. RESULTS: Ring and patch initiators were more likely than women starting oral contraceptives to report that they chose their method due to provider counseling (p<0.001). Contraceptive knowledge in general was low, but initiation of a new method, the ring, was associated with higher knowledge about all methods after seeing the provider (p<0.001). Method initiated varied with provider site (p<0.001). These associations remained significant, controlling for demographics and factors describing the provider-patient relationship, including trust in provider and continuity of care. CONCLUSION: Women's reports of provider counseling and of their own contraceptive knowledge after the visit was significantly associated with hormonal method initiated. PRACTICE IMPLICATIONS: More extensive counseling and patient education should be expected for successful integration of new hormonal methods into clinical practice.

Predictors of contraception knowledge and use among postpartum adolescents in El Salvador.

OBJECTIVE: This study was undertaken to describe demographics and contraceptive familiarity and use among postpartum adolescents in El Salvador. STUDY DESIGN: Questionnaire-guided interviews were conducted in Spanish with 50 postpartum adolescents at an urban, public hospital in El Salvador. Open-ended questions included assessments of education, partnership status, and contraceptive knowledge and use patterns. RESULTS: The median age of subjects was 17 years, 84% were nulliparous, 80% had partners, and 6% were married. Eighty-four percent of the women reported contraception knowledge and 18% reported contraception use. Educational experience and literacy predicted contraceptive knowledge (P = .008 and .001, respectively), but not use. After delivery and postpartum contraception education, 58% of the subjects stated intention to use contraception. Having a partner and living with him were predictors of intent to use contraception (P = .001 and .002, respectively). Being single negatively predicted intention to use contraception (P = .001). CONCLUSION: Education and literacy predicted contraceptive knowledge; however, contraceptive knowledge did not predict contraceptive use. Adolescent contraception use depends on more than just contraceptive knowledge.