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Ensuring access to contraceptive services is an important strategy for preventing unintended pregnancies, which account for nearly one half of all U.S. pregnancies (1) and are associated with adverse maternal and infant health outcomes (2). Equitable, person-centered contraceptive access is also important to ensure reproductive autonomy (3). Behavioral Risk Factor Surveillance System (BRFSS) data collected during 2017-2019 were used to estimate the proportion of women aged 18-49 years who were at risk for unintended pregnancy* and had ongoing or potential need for contraceptive services.† During 2017-2019, in the 45 jurisdictions§ from which data were collected, 76.2% of women aged 18-49 years were considered to be at risk for unintended pregnancy, ranging from 67.0% (Alaska) to 84.6% (Georgia); 60.7% of women had ongoing or potential need for contraceptive services, ranging from 45.3% (Puerto Rico) to 73.7% (New York). For all jurisdictions combined, the proportion of women who were at risk for unintended pregnancy and had ongoing or potential need for contraceptive services varied significantly by age group, race/ethnicity, and urban-rural status. Among women with ongoing or potential need for contraceptive services, 15.2% used a long-acting reversible method (intrauterine device or contraceptive implant), 25.0% used a short-acting reversible method (injectable, pill, transdermal patch, or vaginal ring), and 29.5% used a barrier or other reversible method (diaphragm, condom, withdrawal, cervical cap, sponge, spermicide, fertility-awareness-based method, or emergency contraception). In addition, 30.3% of women with ongoing or potential need were not using any method of contraception. Data in this report can be used to help guide jurisdictional planning to deliver contraceptive services, reduce unintended pregnancies, ensure that the contraceptive needs of women and their partners are met, and evaluate efforts to increase access to contraception.

Web- and application-based prescription services have been heralded as “Uber for birth control,” offering patients the convenience of obtaining hormonal contraceptives at the touch of a smartphone screen. This innovation stands poised to disrupt a system that currently fails to meet the contraceptive needs of many women, particularly adolescents and those who are rural or low-income. The creation of online contraceptive prescribers provides a new and promising avenue for increased access to hormonal birth control. However, the reach and coverage of these services, as well as their implications for public health goals, including unintended pregnancy and various health screenings, remains unclear. In this article, we describe the current landscape of online contraceptive services and identify the potential impacts on unplanned pregnancy and other health outcomes. We find these services may reduce geographic and logistical barriers for rural and low-income populations. However, their impact on access for adolescents is likely to be minimal, as more than half the services do not prescribe to minors. Furthermore, increasing use of telemedicine may reduce rates of screening for public health concerns, including interpartner violence, sexually transmitted infections, and cervical cancer. We offer specific recommendations for future research to evaluate the impact of these services on unplanned pregnancy and other public health outcomes.

Objective To provide guidelines for health care providers on the use of contraceptive methods to prevent pregnancy and on the promotion of healthy sexuality. Outcomes Overall efficacy of cited contraceptive methods, assessing reduction in pregnancy rate, safety, ease of use, and side effects; the effect of cited contraceptive methods on sexual health and general well-being; and the relative cost and availability of cited contraceptive methods in Canada. Evidence Published literature was retrieved through searches of Medline and The Cochrane Database from January 1994 to January 2015 using appropriate controlled vocabulary (e.g., contraception, sexuality, sexual health) and key words (e.g., contraception, family planning, hormonal contraception, emergency contraception). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies published in English from January 1994 to January 2015. Searches were updated on a regular basis in incorporated in the guideline to June 2015. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. Values The quality of the evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). Chapter 7: Intrauterine Contraception Summary Statements 1.Intrauterine contraceptives are as effective as permanent contraception methods. (II-2) 2.The use of levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg by patients taking tamoxifen is not associated with recurrence of breast cancer. (I) 3.Intrauterine contraceptives have a number of noncontraceptive benefits. The levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg significantly decreases menstrual blood loss (I) and dysmenorrhea. (II-2) Both the copper intrauterine device and the LNG-IUS significantly decrease the risk of endometrial cancer. (II-2) 4.The risk of uterine perforation decreases with inserter experience but is higher in postpartum and breastfeeding women. (II-2) 5.The risk of pelvic inflammatory disease (PID) is increased slightly in the first month after intrauterine contraceptive (IUC) insertion, but the absolute risk is low. Exposure to sexually transmitted infections and not the IUC itself is responsible for PID occurring after the first month of use. (II-2) 6.Nulliparity is not associated with an increased risk of intrauterine contraceptive expulsion. (II-2) 7.Ectopic pregnancy with an intrauterine contraceptive (IUC) is rare, but when a pregnancy occurs with an IUC in situ, it is an ectopic pregnancy in 15% to 50% of the cases. (II-2) 8.In women who conceive with an intrauterine contraceptive (IUC) in place, early IUC removal improves outcomes but does not entirely eliminate risks. (II-2) 9.Intrauterine contraceptives do not increase the risk of infertility. (II-2) 10.Immediate insertion of an intrauterine contraceptive (10 minutes postplacental to 48 hours) postpartum or post-Caesarean section is associated with a higher continuation rate compared with insertion at 6 weeks postpartum. (I) 11.Immediate insertion of an intrauterine contraceptive (IUC; 10 minutes postplacental to 48 hours) postpartum or post-Caesarean section is associated with a higher risk of expulsion. (I) The benefit of inserting an IUC immediately postpartum or post-Caesarean section outweighs the disadvantages of increased risk of perforation and expulsion. (II-C) 12.Insertion of an intrauterine contraceptive in breastfeeding women is associated with a higher risk of uterine perforation in the first postpartum year. (II-2) 13.Immediate insertion of an intrauterine contraceptive (IUC) post-abortion significantly reduces the risk of repeat abortion (II-2) and increases IUC continuation rates at 6 months. (I) 14.Antibiotic prophylaxis for intrauterine contraceptive insertion does not significantly reduce postinsertion pelvic infection. (I) Recommendations 1.Health care professionals should be careful not to restrict access to intrauterine contraceptives (IUC) owing to theoretical or unproven risks. (III-A) Health care professionals should offer IUCs as a first-line method of contraception to both nulliparous and multiparous women. (II-2A) 2.In women seeking intrauterine contraception (IUC) and presenting with heavy menstrual bleeding and/or dysmenorrhea, health care professionals should consider the use of the levonorgestrel intrauterine system 52 mg over other IUCs. (I-A) 3.Patients with breast cancer taking tamoxifen may consider a levonorgestrel-releasing intrauterine system 52 mg after consultation with their oncologist. (I-A) 4.Women requesting a levonorgestrel-releasing intrauterine system or a copper-intrauterine device should be counseled regarding changes in bleeding patterns, sexually transmitted infection risk, and duration of use. (III-A) 5.A health care professional should be reasonably certain that the woman is not pregnant prior to inserting an intrauterine contraceptive at any time during the menstrual cycle. (III-A) 6.Health care providers should consider inserting an intrauterine contraceptive immediately after an induced abortion rather than waiting for an interval insertion. (I-B) 7.In women who conceive with an intrauterine contraceptive (IUC) in place, the diagnosis of ectopic pregnancy should be excluded as arly as possible. (II-2A) Once an ectopic pregnancy has been excluded, the IUC should be removed without an invasive procedure. The IUC may be removed at the time of a surgical termination. (II-2B) 8.In the case of pelvic inflammatory disease, it is not necessary to remove the intrauterine contraceptive unless there is no clinical improvement after 48 to 72 hours of appropriate antibiotic treatment. (II-2B) 9.Routine antibiotic prophylaxis for intrauterine contraceptive (IUC) insertion is not indicated. (I-B) Health care providers should perform sexually transmitted infection (STI) testing in women at high risk of STI at the time of IUC insertion. If the test is positive for chlamydia and/or gonorrhea, the woman should be appropriately treated postinsertion and the IUC can remain in situ. (II-2B) 10.Unscheduled bleeding in intrauterine contraception users, when persistent or associated with pelvic pain, should be investigated to rule out infection, pregnancy, gynecological pathology, expulsion or malposition. (III-A)

Oral combined hormonal contraceptives (CHCs) are available that limit the number of menses when used in a flexible extended regimen. Our aim was to investigate the decision-making processes of women presented with a flexible extended CHC option.The FLEXO study is an epidemiological, cross-sectional, multicentre study conducted under typical clinical practice conditions to determine women's acceptance of a flexible continuous CHC regimen versus a cyclical 21/7 day regimen, after receiving standardised information during contraceptive counselling.A total of 1350 women were invited to participate, of whom 1156 were enrolled. Of these, 47.2% chose the flexible extended CHC regimen. Their main reason for choosing this regimen was to reduce the number of menses (25.7%), followed by the desire to avoid symptoms related to menstruation (21.6%). The reasons given for rejecting this regimen were the desire to have monthly menstrual cycles (24.9%) and the fear of becoming pregnant and not being aware of it due to the absence of menstruation (18.1%).Many women chose the extended flexible regimen when they received information about this option. Women primarily chose this pattern to relieve or eliminate discomfort related to menstruation.

Background: Contraceptive use is important to promoting women’s health and protecting their rights. It has been shown to reduce maternal morbidity and mortality. Aim: The study aimed at determining the level of awareness, utilization, preferred methods of contraceptives and factors affecting contraceptive use among female traders of Jos south Local government area of Plateau state. Materials and methods: The study was a cross sectional descriptive study that was carried out among female traders within reproductive age group who were not pregnant and consented for the study. Data was generated using a semi-structured interviewer’s administered questionnaire. Result: Two hundred and twelve women were interviewed, their ages ranged from 15-49 years with a mean age of 30+ 3.72. Majority (69.3%) were married. The level of awareness of modern contraceptives was high (93.4%) and the most popular contraceptive methods were male condom (95.5%), injectable (87.4%) and oral contraceptives pills (85.9%) while the unpopular methods were female condom (40.4%), cervical diaphragm (17.5%), cervical cap (12.1%) and spermicides (12.6%). The prevalence of modern contraceptive utilization was 51.9% while 102 (48.1%) were not using any form of contraceptives. Factors found to be associated with contraceptive use among the female traders included marital status (p

Hysterectomy, that is removal of uterus, is one of the most common major operations in gynecologic surgeries. Laparoscopy technique is preferred in hysterectomy because of its advantages such as lower intra-operative blood loss, decreased surrounding tissue/organ damage, less operating time, lower post-operative infection and frequency of fever, shorter duration of hospitalization and post-operative returning time to normal activity. During total laparoscopic hysterectomy, first uterine vessels and ligaments are cauterized respectively, and then cervicovaginal connections are cauterized and coagulated to remove uterus completely. Uterine manipulators are used during laparoscopy to maximize the endoscopic vision of surgeons by moving related organs. However, conventional uterine manipulators have important drawbacks particularly to move uterus in three dimensions and to show cervicovaginal landmark during laparoscopic circular cauterization which is difficult and hand skill required process, and amputation of the uterine cervix. A new transvaginal uterine manipulator may overcome these important drawbacks of these currently available devices. For this reason, a 3 dimensional (3D) scanning technique was used to obtain real world data such as uterine dimensions and computer aided design software is used in designing of the new manipulator and then 3D printer was used in prototyping. Special light emitting diodes (LEDs) were mounted on the cervical cap of the manipulator to guide light beams from inside of cervicovaginal tissue to abdominal cavity to facilitate the visualization of tissue landmarks. In brief, structural synthesis, CAD and rapid prototyping of parallel manipulator with 2-dof and which allows the uterus to be manipulated in both anterior posterior and lateral axis was performed in the scope of this thesis. Furthermore, a circular LED system was designed and implemented on system to ease the determination of cervicovaginal landmark. In the light of the findings acquired from the study, designed manipulator has ability to manipulate uterus in anterior posterior and lateral axis. Moreover, LED illumination system which can be detected easily by the laparoscope is successfully implemented on the manipulator's cervical cap.

The vagina is a potential route of systemic administration of drugs especially those which can break down in the intestine or those which encounter a first passage hepatic effect. The acidic vagina serves as a barrier against most pathogens. Other characteristics acting as natural barriers to infection include thick mucus a dense network of blood and lymphatic vessels and lactobacilli growth. Vaginal secretions can influence the absorption of drugs administered vaginally. The vaginal approach is beneficial for delivery of progesterone estradiol and prostaglandins. Criteria of intravaginal pharmaceutical preparations are: must not change either the vaginal flora or the normal pH of the mucus and must help to reestablish them; must allow release of active ingredient and regular distribution of the medicine in the vagina; and must penetrate the folds and jagged outlines of the vagina. Intravaginal pharmaceutical preparations also must not cause irritation or marked odor; must not stain clothes or skin must be easy to insert must keep the medicine from leaving the vagina must be compatible with other medicines and must not allow the penis to irritate the vaginal during intercourse. They must be accepted by the patient. Various forms of pharmaceutical preparations include vaginal tablets creams jellies suppositories capsules douches foams and tampons. This literature review stresses problems linked to administration of the intravaginal pharmaceutical preparations their advantages as compared with other vaginal forms and use of these preparations as contraceptive methods.

Chemical contraceptives mainly known as spermicides are one of the oldest types of contraceptives. The industrial revolution facilitated new developments, and they became a leading and widespread method. However, their use declined in the second half of the 20th century, and came under focus again only with the upsurge of sexually transmitted infections (STIs). The effectiveness of spermicides depends on the users' compliance and pregnancy rates vary widely: from 6/100 woman-year (with perfect use) to 26/100 woman-year (with typical use). Preparations consist of two components: an excipient (foam, cream, jelly, soluble film, suppository or tablet); and a chemical agent with spermicidal properties (acidic compound, microbicidal agent, detergent). The most widely used active agent has been the surface active (detergent) nonoxynol-9 (N-9). Based on their mode of action (surfactant effect of detergents, enzymatic action of microbicides on cell metabolism) spermicides were thought to provide protection against STIs including HIV. Recent studies have, however, shown that detergents may actually increase the risk. Because of this, there is an urgent need for a suitable non-detergent spermicide, and research should focus on developing new compounds to replace N-9 and other agents having similar undesired effects. This paper reviews the latest studies reporting results on these recent developments.

Background We explored the potential acceptability of three cervical barriers (CB) (Ortho All-Flex® diaphragm, SILCS® diaphragm, FemCap TM cervical cap) among sexually experienced Zimbabwean young women. Methods Forty-five young women (aged 16–21 years) received an individual CB educational session. Participants were then randomly assigned to one of the three CBs in a 1:1:1 ratio, and practised insertion and removal of their device at the clinic. Next, participants were interviewed on their practice experiences, and their post-practice attitudes towards CB. Results All 45 young women were willing and able to insert their assigned device. The majority reported “easy” insertion and removal and 93% “liked” the device they tried. All showed interest in participating in future CB studies: when asked which device they would like to try in the future, over half (58%) chose SILCS, regardless of the device they had tried. The majority felt comfortable touching their genitals to insert/remove the CB and most participants favoured methods9 attributes associated with female-control and non-interference with sex. Over half the participants said they would prefer to use a CB continuously compared to episodic use. Two-thirds of them expressed interest in CB for dual protection. Conclusion The concept of CB, and initial insertion experience, were well accepted in this selected, small group of Zimbabwean young women. Evaluating CB in larger studies seems feasible in this population.

Background The aim of the study is to explore the effect of gestational diabetes mellitus (GDM) on postpartum contraception among nondiabetic primiparous women. Study Design Secondary analyses of 2004–2005 Pregnancy Risk Assessment Monitoring System data from Michigan and Oregon. Methods Analyses were performed on 2332 women, taking complex survey design into consideration. Crude and adjusted odds ratios (cOR; aOR) and their 95% confidence intervals (CI) were obtained using logistic regression analyses. Results Postpartum use of hormonal (aOR=1.12, 95% CI: 0.68–1.83) and nonhormonal (aOR=1.18, 95% CI: 0.73–1.92) contraception were not influenced by GDM after controlling for confounders. Female sterilization was more frequently adopted (cOR=4.99, 95% CI: 1.13–22.17) and depomedroxyprogesterone acetate (DMPA) (cOR=0.53, 95% CI: 0.23–1.18), diaphragm/cervical cap/sponge (cOR=0.13, 95% CI: 0.016–0.95) and cervical ring (cOR=0.13, 95% CI: 0.017–0.98) were less frequently adopted by women reporting GDM diagnosis. Conclusion With few exceptions, GDM does not appear to affect postpartum hormonal and nonhormonal contraception.

This article describes both barrier and spermicide methods of contraception including the male and female condom, diaphragm, contraceptive sponge, Lea Shield, cervical cap and multiple spermicide options. Their efficacy, differences and proper use are discussed with an emphasis on the adolescent user.

This article is Part II of a practice guideline on contraception for adolescents. Part I reviewed general adolescent reproductive health issues the use of oral contraceptive pills (OCPs) and the contraceptive patch (Part I appeared in the May/June 2004 issue of Journal of Pediatric Health Care). Part II will address a newly-approved formulation of OCPs the use of depot medroxyprogesterone acetate (DMPA) emergency contraception (EC) and the male condom. Condoms although not as effective in preventing pregnancy are important in preventing the transmission of sexually transmitted infections (STIs) and teenagers who use hormonal contraceptive methods should be counseled to use condoms as well. For some teens condoms may serve the dual purpose of preventing STIs and pregnancy. This practice guideline will not include the IUD vaginal spermicides or the group of barrier methods that includes the diaphragm and cervical cap which are not used very commonly by adolescents. Nonoxynol-9 the vaginal spermicide that is used alone in a cream foam or suppository formulation or with the condom diaphragm or cervical cap has been associated with increased rates of HIV transmission. (excerpt)

Objective To assess the short-term acceptability, aspects of use and user satisfaction with the Oves® cap. Design, setting and subjects A multicentre observational study, commissioned by Veos Ltd, manufacturers of the Oves® cap, was carried out by the UK Family Planning and Reproductive Health Research Network in collaboration with the Institute of Population Studies, University of Exeter, Exeter, UK. Women from ten Network centres and one collaborating centre were invited to participate. Following an assessment by vaginal examination women were fitted with the cap and taught self-fitting by a doctor. The women were asked to use the cap six times in 8 weeks. Participants were asked to complete four questionnaires on various aspects of cap use including Likert-type measures and open-ended questions on experiences with the cap. Doctors were asked to complete a first visit and follow-up questionnaires. Women were self-selected clients in the participating centres. Women aged 18 years and over, gynaecologically healthy, using hormonal contraception or sterilised were eligible for the study. Thirty-five women were enrolled and fitted with the cap; 20 chose to participate in the study. Main outcome measures Ease of fitting and removal of the cap expressed in structured and open-ended questions by both cap users and doctors; satisfaction of women and partners with the cap, measured by desire to use the cap in the future and by premature withdrawal from the trial. Results Twenty women used the cap on a total of 84 occasions. Four women completed the trial of six uses. While most doctors did not have difficulty with fittings or removals, 10/20 Oves® cap users reported some difficulty in fitting it over the cervix and 12 reported some difficulty removing it in the first three uses. Fewer women had difficulty in fitting in uses 4-6 but nearly half continued to have some difficulty with removals. Conclusions Few women indicated that they would use the cap in the future. However, most women were satisfied with their current method of contraception. The study raises the question whether women using non-barrier methods of contraception and satisfied with their current method of contraception are the appropriate target recruits for a trial such as this, even in the absence of robust efficacy data.

The aim of this study was to compare the use of a cervical vacuum cap cannula with the traditional metal cannula.A prospective, randomised, single-blinded comparative study.Fifty consecutive infertile women undergoing hysterosalpingography for evaluation of infertilityHysterosalpingography was performed either with the traditional metal cannula (n = 25) or a cervical vacuum cap cannula (n = 25).Length of procedure, fluoroscopic time, amount of contrast medium, pain to the patient while applying the cannula and injecting the contrast medium, level of difficulty to the performer, the need to reapply the cannula, complications, and results of the hysterosalpingography.Using the cervical vacuum cap cannula, compared with the metal cannula, the duration of the procedure was significantly shorter (5.3 vs 9.3 minutes; P0.001), less fluoroscopic time was needed (0.9 vs 1.8 minutes; P0.001), a smaller amount of contrast medium was used (4.6 vs 15.7 mL; P0.001), the procedure caused less pain to the patient (3.2 vs 6.8, respectively; on a scale of 1-10; P0.001), and was easier for the physician to perform (1.4 vs 3.4; on a scale of 1-10; P0.001). No significant differences were encountered between the two groups in the need to reapply the cannula, in the rate of complications or in the results of the hysterosalpingography.The cervical cap cannula appears to be superior to the traditional metal cannula for performing hysterosalpingography.

Intracervical insemination continues to be employed for homologous and donor insemination in natural and stimulated cycles. Efficacy studies for potential fertility involve in vivo assessment; however, in vitro testing of particular sperm function(s) critically involved in fertilization is an important component of such evaluation. We report here on the in vitro evaluation of the effects of the silicone Veos cervical cap (Veos, London, UK) on sperm function. Donor semen was exposed to the Veos cervical cap or a sterile 15-cc centrifuge tube (control), or treated with the spermicide nonoxynol-9 (5 mg x ml(-1) in saline) for 4 h at 37 degrees C and 5% CO2 in water-saturated air. After exposure, motility characteristics, both in semen and in spermatozoa processed by standard swim-up procedure, cervical mucus penetration and sperm-zona pellucida interaction using the hemizona assay were assessed. Results indicated that exposure to the Veos cervical cap had no effect on either sperm motility characteristics or sperm-zona pellucida interaction. A small but significant difference was observed for cervical mucus penetration (P = 0.05); however, for both the control and treated groups, vanguard spermatozoa exceeded manufacturer's guidelines for a normal test, a penetration distance of > or = 30 mm. As expected, nonoxynol-9 was a potent inhibitor of sperm function. Lack of adverse effects on in vitro spermatozoa functional characteristics after exposure to the silicone Veos cervical cap supports its addition to the repertoire of fertility treatment modalities when cervical insemination is indicated.

A brief history and comparison of barrier methods of birth control are reviewed. The clinical trial of theOves® cervical cap, a new barrier method for contraception, is reported. The aim of this study was to evaluate the safety and effectiveness of the Oves® cervical cap. The Oves® cervical cap is made of implantable grade silicone which fits snugly over the cervix. Women (N=17) included in the study were followed at 3-months, 6-months and annually during their participation in the study, for a total of 336 women-months. Clinical data consisted of Pap smear at the initial exam, at 3 months, and annually thereafter. Women completed a monthly diary of side effects and history of their use of the cap with sexual activity. Personal use diaries were tabulated for reported side effects. Data were analysed using standard life-expectancy table analysis to determine contraceptive effectiveness rates. Results showed that the contraceptive failure rate was low, the Oves® cervical cap in this study had a contraceptive effectiveness rate of 100%. There were no serious or severe side effects. Reported side effects consisted of vaginal infection (11 cases in five women) and dislodgement (5 cases). Only one subject discontinued use of the Oves® cervical cap because of discomfort. Overall, women and their partners reported satisfaction with use of the Oves® cervical cap. The major limitation of this study was the small sample size. Current efforts are underway to undertake a larger clinical trial in attempt to win FDA approval to market the device in the US.

A concern with hierarchy messages which promote male condoms and female-controlled barrier methods along a prevention continuum is that they may discourage condom use. This studys aim was to measure male-condom and female-condom use among women who received hierarchy counseling and compare this with women counseled about condoms only. Three observational cohorts that correspond to prevention message received were assembled and consisted of female sexually transmitted disease (STD) clinic patients who were counseled about male condoms female condoms or a hierarchy message. The hierarchy message promoted male and female condoms the diaphragm and cervical cap spermicides and withdrawal in descending order of effectiveness against STDs. After counseling women were interviewed and returned for follow-up visits at 2 weeks 4 months and 6 months. The outcome was the mean proportion of male condom- or female condom-protected coital acts at each follow-up visit in the hierarchy cohort. The outcome was dichotomized as high (70% or more of coital acts protected) or low (fewer than 70%) and generalized estimating equations were used to compare observed follow-up condom use with baseline within the hierarchy cohort and observed follow-up condom use between cohorts. It was assumed that condom use in persons not present at 6 months was equal to baseline levels and condom use estimates were calculated for each full cohort that was initially enrolled. The mean proportion of condom-protected coital acts in the hierarchy cohort was significantly increased from baseline at each follow-up visit. There were no differences in observed condom use during follow up between the hierarchy cohort and either the male-condom or the female-condom cohort. However when the full cohort initially enrolled was considered 6-month condom use was significantly higher in the hierarchy cohort than in the male-condom cohort. Hierarchy counseling was associated with a significant increase in condom use. The authors findings suggest that offering a choice of male and female condoms results in increased protection over counseling in male condoms alone. (authors)

The FemCap is a new silicone rubber barrier contraceptive shaped like a sailor's hat, with a dome that covers the cervix, a rim that fits into the fornices, and a brim that conforms to the vaginal walls around the cervix. It was designed to result in fewer dislodgments and less pressure on the urethra than the cervical cap and diaphragm, respectively, and to require less clinician time for fitting. This was a phase II/III, multicenter, randomized, open-label, parallel group study of 841 women at risk for pregnancy. A subset of 42 women at one site underwent colposcopy. Women were randomized to use the FemCap or Ortho All-Flex contraceptive diaphragm, both with 2% nonoxynol-9 spermicide, for 28 weeks. The objectives were to compare the two devices with regard to their safety and acceptability and to determine whether the probability of pregnancy among FemCap users was no worse than that of the diaphragm (meaning not more than 6 percentage points higher). The 6-month Kaplan-Meier cumulative unadjusted typical use pregnancy probabilities were 13.5% among FemCap users and 7.9% among diaphragm users. The adjusted risk of pregnancy among FemCap users was 1.96 times that among diaphragm users, with an upper 95% confidence limit of 3.01. Clinical equivalence (noninferiority) of the FemCap compared with the diaphragm, as defined in this study, would mean that the true risk of pregnancy among FemCap users was no more than 1.73 times the pregnancy risk of diaphragm users. Because the observed upper 95% confidence limit (and even the point estimate) exceeded 1.73, the probability of pregnancy among FemCap users, compared with that among diaphragm users, did not meet the definition of clinical equivalence used in this study. The FemCap was believed to be safe and was associated with significantly fewer urinary tract infections. More women reported problems with the FemCap with regard to insertion, dislodgement, and especially removal, although their general assessments were positive. The two devices were comparable with regard to safety and acceptability, but a 6-point difference in the true 6-month pregnancy probabilities of the two devices could not be ruled out. Further studies are needed to determine whether design modifications can simplify insertion and removal.

Objective To develop a female barrier to, first, prevent pregnancy and, second, protect against sexually transmitted diseases.Design The contraceptive is made of inert, soft material and is an anatomical design that utilizes the physiology of the vagina. It incorporates the use of microbicidal spermicide to kill sexually transmitted disease organisms.Results FemCap has been proven in clinical trials to be safe, and has no systemic or local side-effects, and does not increase the risk of urinary tract infections. Effectiveness in pregnancy prevention is 86.5% in typical use and 98% if used properly with emergency contraceptives as back-up. FemCap is highly acceptable to women and to their partners.Conclusions A new method of birth control has arrived that is safe, effective, highly acceptable and may protect against sexually transmitted diseases of the upper female genital tract.

The objectives of the study were to assess the ability of the Femcap, a new vaginal contraceptive device made of silicone and designed to fit snugly around the cervix to prevent the penetration of sperm into midcycle cervical mucus when used with and without spermicide; and to compare it with the standard contraceptive diaphragm used with spermicide. Eight women underwent two baseline cycles of postcoital testing in which no device was used, followed by three test cycles in which Femcap with spermicide, Femcap with nonspermicidal lubricant (K'Y gel) or the Ortho All-Flex diaphragm with spermicide was used. The sequence of testing cycles was randomized. In each cycle, condoms were used prior to midcycle, then a midcycle cervical mucus specimen was examined to ensure midcycle characteristics and the absence of sperm. Each woman then had intercourse using either no device (baseline cycles) or the prescribed device (test cycles) and returned 2-3 h afterwards. Cervical mucus was again assessed for adequacy and the presence of spermatozoa. The average number of progressively motile sperm seen per high power field was as follows: first baseline cycle, 18.0; second baseline cycle, 17.8; test cycle with Femcap used with nonspermicidal lubricant, 0.1; test cycle with Femcap used with spermicide, 0.2; and test cycle with the diaphragm used with spermicide, 0.0. There was no significant difference between baseline cycles or among test cycles in the average number of progressively motile sperm seen (p > 0.05). The average number of progressively motile sperm seen in each test cycle did, however, differ significantly from the average number seen in either baseline cycle (p < 0.05). Femcap, used with either a spermicidal lubricant or a nonspermicidal lubricant, appears to be comparable with the diaphragm used with spermicide in preventing sperm from entering midcycle cervical mucus.

In the face of legal challenges and adverse scientific publications that threaten the acceptance of various methods of contraception this article reviews the forms of contraception currently available in the US and assesses their safety efficacy and medical benefits. Information is provided on 1) male and female condoms which offer protection from pregnancy and from sexually transmitted diseases; 2) the spermicide Nonoxynol-9 which kills harmful microorganisms but is toxic to vaginal epithelium; 3) the contraceptive sponge; 4) the diaphragm (used with spermicides) and cervical cap; 5) Norplant which is associated with troublesome side effects but still scores 78% satisfaction ratings; 6) Depo-Provera which has been associated with bone loss; and 7) IUDs which were used by 10% of women in the 1970s but are used by less than 2% today. The bulk of the report is devoted to oral contraceptives (OCs) which are described as "one of the most thoroughly studied pharmacological agents of the 20th century." The risks associated with OC use are reviewed as are such topics as failure rates mechanism of action side effects beneficial effects effects of use on cancer rates safety for breast-feeding women contraindications and the risk of venous thromboembolism associated in recent studies with formulations containing third-generation progestins. It is concluded that the development of contraceptive technology is being guided by a new emphasis on protecting health while preventing pregnancy.

The purpose of this study was to evaluate the safety, efficacy and acceptability of Lea's Shield, a new vaginal contraceptive barrier device, when used with either spermicidal or non-spermicidal lubricant. One-hundred-eighty-five (185) women enrolled at six centers. Half were randomized to use the device with spermicide and half with a non-spermicidal lubricant. To be eligible, volunteers had to be 18-40 years old (inclusive), in good health with regular menses, sexually active in an ongoing relationship and at risk for pregnancy, and willing to use Lea's Shield as their sole means of contraception for six months. Participants were seen at admission, one week, one month, three months and six months. Gross cumulative life table rates were calculated for pregnancy and others reasons for discontinuation. Adverse experiences and responses to an acceptability questionnaire were evaluated. One-hundred-eighty-two (182) volunteers contributed data to the analysis of safety and 146 to that of contraceptive efficacy. The unadjusted six-month life table pregnancy rate was 8.7 per 100 women for spermicide users and 12.9 for non-spermicide users (p = 0.287). After controlling for age, center, and frequent prior use of barrier methods, the adjusted six-month life table pregnancy rate was 5.6 for spermicide users and 9.3 for non-spermicide users (p = 0.086), indicating that use of spermicide lowered pregnancy rates, although not significantly, during typical use. For purposes of comparison, it is important to note that this study differed from the cap/diaphragm and sponge/ diaphragm studies in that a high percentage (84%) of volunteers were parous. For reasons that are unclear, pregnancy rates among parous women using barrier contraceptives tend to be higher than among nulliparous women. Indeed, in this study there were no pregnancies among nulliparous users of Lea's Shield. Standardization of parity of this study population on those of the cap/diaphragm and sponge/diaphragm studies suggests that unadjusted pregnancy rates for this device would have been considerably lower (2.2 and 2.9 per 100 users of spermicide and non-spermicide, respectively) had the study been done using the populations of earlier studies. Since no directly comparative study has been done, these figures provide a tentative estimate of the relative efficacy of Lea's Shield compared with the sponge, cap, and diaphragm. There were no serious adverse experiences attributed to the use of Lea's Shield. Acceptability was very good. Seventy-five percent (75%) of women responded to an end-of-study questionnaire; 87% of these reported that they would recommend Lea's Shield to a friend. Lea's Shield is a new vaginal contraceptive that does not require clinician fitting. Pregnancy rates in this study compare favorably with other studies of barrier contraceptive methods including the cervical cap, diaphragm, and sponge, even though this study was done with greater rigor and with a greater percentage of parous women than previous barrier studies. Lea's Shield appears to be safe and very acceptable to study volunteers.At six US centers, between August 1991 and October 1993, a prospective, double-blind, randomized clinical trial was conducted to evaluate the contraceptive efficacy of Lea's Shield (a new vaginal contraceptive barrier device) used with and without a spermicidal lubricant as well as its safety and acceptability. The clinical researchers enrolled 185 healthy women aged 18-40 who menstruated regularly, were sexually active, and at risk for pregnancy. 84% of the women were parous. They were asked to use Lea's Shield as their only contraceptive method for 6 months. The analysis of safety included 182 women, while that of contraceptive efficacy included 146 women. The adjusted 6-month life table pregnancy rate for spermicide users was lower than that for non-spermicide users (5.6% vs. 9.3%), but not significantly so (p = 0.086). None of the nulliparous women conceived, however. When the researchers standardized parity in this study population comparable to the parity of cap/diaphragm and sponge/diaphragm studies, the unadjusted and adjusted pregnancy rates would have been much lower (2.2% for spermicide users vs. 2.9% for non-spermicide users and 1.3% vs. 2.6%, respectively). No woman experienced serious or unexpected adverse effects using Lea's Shield. Discontinuation rates for device-related reasons were low (7.8% for spermicide users and 6.7% for non-spermicide users). 87% of women who completed an end-of-study questionnaire and 69% of men would recommend Lea's Shield to a friend. 84% of women and 55% of their partners liked Lea's Shield. 84% of women who had an opinion on the diaphragm preferred Lea's Shield. The aspects most liked were convenience and ease of insertion. These findings suggest that this new vaginal barrier contraceptive (available in one size fits all) has a relatively good contraceptive efficacy compared with other barrier methods and is safe and acceptable.

A recent multi-country study on hormonal contraceptives (HC) and HIV acquisition and transmission among African HIV-serodiscordant couples reported a statistically significant doubling of risk for HIV acquisition among women as well as transmission from women to men for injectable contraceptives. Together with a prior cohort study on African women seeking health services, these data are the strongest yet to appear on the HC-HIV risk. This paper will briefly review the Heffron study strengths and relevant biological and epidemiologic evidence; address the futility of further trials; and propose instead an alternative framework for next steps. The weight of the evidence calls for a discontinuation of progestin-dominant methods. We propose here five types of productive activities: (1) scaling injectable hormones down and out of the contraceptive mix; (2) strengthening and introducing public health strategies with proven potential to reduce HIV spread; (3) providing maximal choice to reduce unplanned pregnancy, starting with quality sexuality education through to safe abortion access; (4) expanding provider training, end-user counseling and access to male and female barriers, with a special renewed focus on female condom; (5) initiating a serious research agenda to determine anti-STI/HIV potential of the contraceptive cervical cap. Trusting women to make informed choices is critical to achieve real progress in dual protection.

To evaluate the relation between contraceptive methods and cervical Chlamydia trachomatis infection, the authors studied a population-based sample of 1,779 nonpregnant women aged 15-34 years who underwent cell culture diagnostic testing for the detection of C. trachomatis at a health maintenance organization. Barrier contraceptive method users were classified as those who reported using one of the following methods at time of testing: condom, diaphragm, cervical cap, spermicidal sponge, foam, or vaginal spermicidal suppositories. Barrier methods were associated with a reduction in the risk of chlamydial infection in women aged 25 years or older when compared with all other women in the same age category (adjusted prevalence odds ratio = 0.15, 95% confidence interval (CI) 0.04-0.66). When compared with only noncontracepting women, the adjusted prevalence odds ratio was 0.34 (95% CI 0.06-1.99). The protective effect of barrier methods was not evident in women younger than age 25 years. Oral contraceptive use was not associated with the risk of C. trachomatis infection using either referent group; the adjusted prevalence odds ratio was 0.99 (95% CI 0.57-1.73) compared with all other women, and 0.88 (95% CI 0.44-1.79) compared with noncontracepting women. These findings suggest that present patterns of use of barrier methods differ by age and afford only selective protection against cervical C. trachomatis infections.Chlamydia trachomatis infection is among the most prevalent of sexually transmitted diseases in young women in the US. Approximately 2.6 million women are estimated to be infected annually in the country. The authors investigated the relation between contraceptive methods and cervical Chlamydia trachomatis infection in a population-based sample of 1779 nonpregnant women aged 15-34 years attending two primary care clinics at Group Health Cooperative of Puget Sound between January 1988 and June 1989. 3.8% of the women were infected with C. trachomatis. Cervical chlamydial infection occurred more often in women younger than age 25 years, of black race, low income level, single marital status, in nulliparous women, women having douched during the preceding year, and those having two or more sexual partners in the preceding year. Overall, the risk of cervical C. trachomatis infection among barrier method users was lower than among all other women. Condoms, diaphragms, cervical caps, spermicidal sponges, foam, and vaginal spermicidal suppositories are barrier contraceptives. The greatest protective effect among barrier method users was found in women aged 25 years or older. Overall, there was no association between the use of oral contraceptives and chlamydial infection. These findings therefore suggest that present patterns of use of barrier methods differ by age and afford only selective protection against cervical infection with C. trachomatis.

This handbook written for the campesinos of the Mexican province of Sinlao can be useful to all peasants living far away from a doctor. It is written in the simplest language comprehensible to people with little or no education. Beside giving advice on what to do when a doctor is not available the book clearly describes which illnesses and diseases absolutely require medical attention and what to do in case of emergency. A long chapter is dedicated to the traditional witchcraft practices of the peasants explaining their danger. Other chapters are dedicated to the importance of good nutrition vaccination cleanliness childrens diseases and problems related to old age. Simple measures of preventive medicine are explained as well as how to treat the most common skin diseases. Special chapters are dedicated to pregnancy complications and to delivery and to modern methods of contraception. This book which is illustrated with simple explicative drawings has an appendix on the use and dosages of the most common drugs and a very useful short dictionary which translates into the dialects of the campesinos the most difficult medical words.

A national survey of obstetrics and gynecology residents was conducted in order to investigate their contraceptive practices and attitudes of residents both personally and professionally. In April 1992 4900 questionnaires were mailed to the 275 obstetrics and gynecology US residency program directors to distribute anonymously to their residents. 1091 questionnaires (29% of those mailed) were returned representing 3761 residents in 218 of the 275 programs surveyed. 25% of respondents experienced at least 1 unplanned pregnancy (mean 0.35) men more commonly than women (28% vs. 21% p = 0.01). Among the 1062 respondents who had been sexually active only 15 (1.4%) had never used contraception. The oral contraceptive (OC) pill the most common current method of contraception (59%) was significantly more prevalent among female residents than among female partners of male residents (p < 0.001). Condom use was more prevalent among male residents than among partners of female residents (p = 0.005). Condom users were significantly less satisfied than tubal ligation vasectomy and OC users (4.4 on a scale of 1 through 7 vs. 6.3 6.0 and 6.0 respectively p < 0.05). 283 (26%) of respondents stated that they would not use the intrauterine device (IUD) personally but might recommend it to their patients. Similar attitudes were expressed for tubal ligation (16%) subdermal implants (16%) vasectomy (15%) the rhythm method (12%) diaphragm (10%) cervical cap (8%) OC (7%) spermicide (7%) and condoms (5%). When controlled for age parity and marital status and using log linear analysis gender had a statistically significant impact on the use of several contraceptive methods. Female residents were 5 times more likely than a comparably educated nonphysician group of women to use OCs. Women in the nonphysician national group were significantly more likely to use other methods of contraception. Controlling for demographic variables male and female residents had different attitudes on contraceptive use. Residents believed that OC use was safe and reliable for themselves and their patients but demonstrated doubt about their own use of an IUD.

Objective To compare pregnancy outcome after IUI versus cervical cap insemination in a donor insemination program. Design A randomized prospective clinical trial in which patients were alternately inseminated with cryopreserved human semen using either IUI or cervical cap insemination methods. Setting The donor insemination program at Washington University School of Medicine. Patients Forty-two women with either isolated male factor or male factor plus corrected ovulatory dysfunction using clomiphene citrate underwent 141 cycles of donor insemination. Main Outcome Measures Clinical pregnancy rates (PRs) defined as a viable intrauterine gestation > 12 weeks or delivered were compared between groups using the χ 2 test. Results Clinical PRs were significantly higher in the IUI group (16.4%) compared with the cervical cap insemination group (5.9%). The spontaneous abortion rates were similar between the IUI (1.4%) and cervical cap insemination groups (4.4%). Conclusions These findings suggest an advantage to IUI over cervical cap insemination in a donor insemination program.

Barrier contraceptive devices like the cervical cap and diaphragm and menstrual collecting devices may block menstrual flow, increase retrograde menstruation, and thus theoretically increase the likelihood of developing endometriosis or adenomyosis. We describe the case of a woman with a prior tubal ligation who after 4 years of regular use of the Keeper®, a menstrual collecting device, developed adenomyosis and endometriosis.

Nexplanon(®) is a new long-term reversible contraception method. The current review is aimed to analyze the published data concerning the contraceptive effectiveness of Nexplanon(®) and its effects on reproductive function. Pharmacological properties and technical procedures of insertion and removal, as well as the efficacy and safety data available, were discussed. Possible strategies for treating Nexplanon(®)-related bleeding were also described. With regard to the future research and the future scientific developments of contraceptive implants, the possible use of Nexplanon(®) wide-ranging for the symptomatic treatment of endometriosis and premenstrual syndrome (PMS) were considered. Finally, it was defined in which women the use of Nexplanon(®) is indicated and in which it is contra-indicated.

Humans have tried to control fertility for centuries. Primitive, preliterate societies practiced infanticide and abortion. When primitive women understood the advantages of conception control, they tried, when possible, to use contraception. In the 4th century B.C., Plato and Aristotle advocated a one-child family. Greek medical literature reported a hollow tube inserted through the cervix into the uterus and a potion as contraceptives. Islamic physicians had much knowledge about conception control. The attitudes toward contraception. In the 5th century B.C., Saint Augustine condemned contraception, even among married couples. The condom emerged in the early modern period. Yet, they were usually worn to protect against disease, e.g., bilharzia in Egypt and syphilis in Europe. The cervical cap and the diaphragm are examples of occlusive pessaries. By 1880, contraceptives and spermicides were advertised. In 1928, the IUD joined the existing contraceptives. Today we have combined oral contraceptives. Judaic law requires husbands to fulfill their wives sexual needs, separate from their duty to procreate. It also calls men, not women, to procreate and forbids men from masturbating, thus Judaic law does not forbid women from practicing contraception. The Roman Catholic church forbids contraceptive use because it is a sin against nature. Some Protestant denominations have allowed contraceptive use. Islamic law states that children are gifts from Allah. Some Moslems believe that they must have many children, but Allah and the Prophet state that children have rights to education and future security. These rights allow couples to prevent pregnancy. Neither Hinduism nor Buddhism prohibit contraceptive use. Differences in husband-wife communication, sex roles, access to contraceptives, and traditional family values will have more of an effect on contraceptive use and fertility than theological barriers or the social class of religious groups.

Objective The objective of the study was to characterize beliefs about contraception among obstetrician-gynecologists. Study Design National mailed survey of 1800 US obstetrician-gynecologists. Criterion variables were whether physicians have a moral or ethical objection to, and whether they would offer, 6 common contraceptive methods. Covariates included physician demographic and religious characteristics. Results One thousand one hundred fifty-four of 1760 eligible obstetrician-gynecologists responded (66%). Some obstetrician-gynecologists object to intrauterine devices (4.4% object, 3.6% would not offer), progesterone implants and/or injections (1.7% object, 2.1% would not offer), tubal ligations (1.5% object, 1.5% would not offer), oral contraceptive pills (1.3% object, 1.1% would not offer), condoms (1.3% object, 1.8% would not offer), and the diaphragm or cervical cap with spermicide (1.3% object, 3.3% would not offer). Religious physicians were more likely to object (odds ratio, 7.4) and to refuse to provide a contraceptive (odds ratio, 1.9). Conclusion Controversies about contraception are ongoing but among obstetrician-gynecologists, objections and refusals to provide contraceptives are infrequent.

Contraceptive diaphragms and cervical caps are two of the nonhormonal barrier contraceptive devices available for use today. Use of these devices has declined over several decades due to the increasing variety of other methods available, but they still have a place in providing contraception for certain carefully selected women. Caps and diaphragms are good contraceptives for women who are unable to tolerate hormones; they are both inexpensive and are durable. They are also intermittently used contraceptives which may be an advantage for those who require contraceptives on an infrequent basis.

Barriers and spermicides are being developed for the prevention of unwanted pregnancy and sexually transmitted infection. The inconvenience of current methods limits their acceptability and leads to higher user failure rates. New methods, such as female condoms, nonlatex male condoms, and new cervical caps are being developed: the Reality (Wisconsin Pharmacal, Jackson, WI) polyurethane vaginal pouch has already received conditional Food and Drug Administration approval for use in the United States. The material used in a Food and Drug Administration-approved nonallergenic glove is being tested for its effectiveness as a condom. In addition, the Fem Cap, a cervical cap that had a life table probability of failure within 1 year of 4.8%, is expected to be available within the next 2 years. It is important for clinicians to be informed of new options becoming available for those patients who may be good candidates for these barrier methods.

The Fem Cap, a silicone rubber cervical cap, is shaped like a sailor's hat. While its dome covers the cervix, its rim fits snugly into the vaginal fornices, and its brim adheres and conforms to the vaginal walls. A spermicidal material is applied to the cap, then it is positioned over the cervix by hand or with a special applicator. The device is removed by hand up to 48 hours after insertion, but no sooner than eight hours after intercourse. Women chosen for the trial had contraindications to or were dissatisfied with the currently available contraceptive methods. Each woman was fitted with a cap of suitable size and instructed in its use. She was then asked to note any side effects and the dates of her menses in a diary. One-hundred-twenty-one women were enrolled in the study. Five became pregnant. Of those, two reported dislodgment of the cap during intercourse; the other three admitted to non-use of the cap on several occasions. This device has proven so far to be safe, effective and acceptable to women and men. It has several advantages over the currently available barrier contraceptive devices. The silicone rubber material from which it is made is non-allergenic, durable and easy to clean. Its design fits the anatomy and accommodates physiological changes. The Fem Cap is easy to insert and remove; an applicator facilitates insertion for some women. Instruction for use of the device requires short time from the health care provider.

Barrier contraceptives are a safe alternative to hormonal methods of fertility management. Newer barrier method options include the Today Sponge, the FemCap, and the Lea's Shield. Understanding the use, benefits, and limitations of these barrier methods of birth control will assist women's health care providers to better meet the family planning needs of their patients.

International audience; BACKGROUND: This study examines contraceptive discontinuation due to method dissatisfaction among women in the United States. STUDY DESIGN: The study population, drawn from the 2002 National Survey of Family Growth, consisted of 6724 women (15-44 years of age) who had ever used a reversible contraceptive method. We first estimated the overall proportion of women who had ever discontinued their contraceptive due to dissatisfaction. We then calculated method-specific discontinuation risks due to dissatisfaction and analyzed the reasons for dissatisfaction given by women who had ever stopped using Norplant, Depo-Provera, oral contraceptives or condoms. RESULTS: Overall, 46% of women had ever discontinued at least one method because they were unsatisfied with it. Dissatisfaction-related discontinuation risks varied widely by method: the diaphragm and cervical cap showed the highest proportions of such discontinuation (52%), followed by long-acting hormonal methods (42%). Oral contraceptives were associated with an intermediate risk of dissatisfaction-related discontinuation (29%), while condoms had the lowest risk (12%). CONCLUSION: A broader understanding of women's concerns and experiences using contraception could help health care providers redesign counseling strategies to improve contraceptive continuation.

Objectives To determine the number of women fitted with a diaphragm or cervical cap at family planning clinics across the Australian State of New South Wales (NSW) from 2000 to 2005. To compare the demographic characteristics of women fitted with this form of contraceptive with women prescribed the combined oral contraceptive pill (COCP). Method An audit of women presenting for contraceptive services between 2000 and 2005 was undertaken. The demographic characteristics of women fitted with a barrier method or prescribed the COCP between 1st April, 2002, and 31st October, 2004, were obtained from the Family Planning NSW Activity Data Set (FADS). Results The proportion of women fitted with a diaphragm or cap remained constant between 2001 and 2005 at approximately 5%. During the 31 months that the study period lasted, 793 women were fitted with a diaphragm or cervical cap compared with 8047 women prescribed the COCP during the same time frame (including 76 women who received both a diaphragm and COCP prescription during this period). Women fitted with the barrier contraceptive were significantly more likely to be older, to have received a tertiary level education and to have private health insurance than their counterparts prescribed the COCP. They were less likely to come from a non-English speaking background. Discussion The diaphragm and cervical cap are viable contraceptive methods for a specific group of older, well-educated women. The possible benefits of female-controlled barrier devices in the prevention of sexually transmissible infections may result in a wider demographic use in the future.