Changes in the intensity and pleasantness of human vaginal odors during the menstrual cycle.

Men and women estimated (by the method of magnitude estimation) the pleasantness and intensity of the odors of vaginal secretions sampled from consecutive phases of 15 ovulatory menstrual cycles of four women. On the average, secretions from preovulatory and ovulatory phases were slightly weaker and less unpleasant in odor than those from menstrual, early luteal, and late luteal phases. However, considerable variation in odor patterns was present across cycles from the same donor, as well as across cycles from different donors. These results indicate that human vaginal odors change slightly in both pleasantness and intensity during the menstrual cycle, but do not support the notion that such odors are particularly attractive to humans in an in vitro test situation.

Sexual and reproductive risk factors for invasive squamous cell cervical cancer.

A case-control study of 418 women with invasive squamous cell cervical cancer and 704 population controls enabled evaluation of risk factors for this relatively rare cancer. Consistent with an infectious etiology was a pronounced effect of multiple sexual partners, with those reporting 10 or more partners being at a significant threefold excess risk. Early first intercourse also was associated with some residual effect on risk, although the relationship was not linear, nor the explanation readily apparent. Those with multiple births were at significantly elevated risks, even after adjustment for sexual parameters. Menstrual and hygiene factors, including use of tampons, vaginal deodorants, and douching products, were not consistently related to risk. Histories of specific infections involving the genital tract were poor predictors of risk, since few women provided positive responses, but those with nonspecific diseases were at a significant twofold excess risk.

IUD use and unexplained vaginal bleeding.

The Women's Health Study, a concurrent case-control study at 16 hospitals in 9 cities across the United States, examined the relationship between intrauterine contraceptive device (IUD) use and unexplained vaginal bleeding severe enough to require hospitalization. There were 545 eligible cases and 3453 controls. Analysis of all patients showed no association between IUD use and hospitalization for unexplained vaginal bleeding. When cases were analyzed separately with regard to prior episodes of vaginal bleeding, those patients with a history of vaginal bleeding had a decreased risk of hospitalization. Among cases, no significant differences between IUD users and nonusers were found in rates of anesthesia, blood transfusion, dilatation and curettage, or hysterectomy. The significant decreased risk between current IUD use (within 3 months before the study) and hospitalization for unexplained vaginal bleeding among women with a history of vaginal bleeding may reflect selective nonprescription for IUDs related to past episodes of vaginal bleeding.

Emotional distress patterns among women having first or repeat abortions.

Thirty-five percent of a sample of 413 women undergoing first-trimester abortions were repeating abortions. All patients rated their emotional symptoms on an SCL-90 scale and completed a brief demographic questionnaire. Preabortion and postabortion emotional distress factors and associated demographic characteristics were compared for women having first and those undergoing repeat abortions. Elevated distress levels were similar in both groups prior to abortion procedures, particularly depression, anxiety, and somatization. After abortion, repeat aborters continued to have significantly higher emotional distress scores in dimensions relating to interpersonal relationships. The variables that discriminated most between first and repeat abortion groups were number of living children, race, and phobic anxiety.

Effect of academic affiliation and obstetric volume on clinical outcome and cost of childbirth.

OBJECTIVE: To determine whether the academic affiliation and obstetric volume of the delivering hospital has an impact on clinical and economic outcomes. METHODS: We performed a cross-sectional analysis of data for all births in the State of Maryland during 1996. Acute hospital discharge data were obtained from the publicly available Maryland Health Services Cost Review Commission database. Institutions were classified as community hospitals, community teaching hospitals, and academic medical centers. Principal outcome variables included cesarean birth and complication rates, total hospital charges, and length of stay. RESULTS: A total of 63,143 cases were identified for analysis. The cesarean delivery rate was lower among academic medical centers, compared with community teaching hospitals and community hospitals (18.4% compared with 24.3% and 21.2%, respectively). After adjustment for patient case-mix, the adjusted odds ratio (OR) for cesarean birth was 0.66 at academic medical centers and 1.23 at community teaching hospitals compared with community hospitals (P <.01). Rates of episiotomy and serious complications were lower at academic medical centers compared with community hospitals. Adjusted total hospital charges were lower and length of stay was shorter for community hospitals compared with academic medical centers ($2937 compared with $3564 and 2.2 days compared with 2.5 days, respectively). CONCLUSION: Hospital academic affiliation was an important predictor of clinical outcomes. Better clinical outcomes were found primarily among patients at academic medical centers, although these institutions demonstrated moderately higher resource utilization, compared with community hospitals.

Comparison of adolescent and adult experiences with Norplant levonorgestrel contraceptive implants.

OBJECTIVE: To compare acceptability, tolerance of side effects, and continuation rates among adolescent and adult Norplant accepters. METHODS: An 18-month observational study was conducted of 136 adolescents and 542 adults who received Norplant at the Francis Scott Key Medical Center in Baltimore, Maryland. Data were collected from the following: a self-administered history form completed at the preinsertion visit, a self-administered follow-up form completed at routine follow-up visits, problem-visit chart review, and telephone contact for patients noncompliant with follow-up appointments. RESULTS: The adolescents ranged in age from 13-18 years (mean 16.4), and adults ranged in age from 19-46 (mean 24.7). The mean parity among teenagers was 1.4; among adults, 3.2. Thirty-nine percent of teenagers and 64% of adults had had one or more therapeutic abortions. Forty percent of adolescents and 47% of adults reported at least one contraceptive failure in the past. Both adolescent and adult Norplant accepters made few telephone calls or problem visits because of complaints or side effects. Compliance with routine annual follow-up was poor for adolescents (24 of 136, 18%) and adults (72 of 542, 13%). Follow-up of noncompliant patients revealed low rates of implant removal. Fifteen adolescents (11%) and 60 adults (11%) had Norplant removed. The most common reasons for removal included irregular bleeding, weight gain, headaches, and desire for pregnancy. CONCLUSIONS: Implant acceptability, continuation, and tolerance of side effects were high and comparable among adolescent and adult accepters. Initial implant users were primarily adolescents or adults who had experienced problems with other forms of reversible contraception. Adherence to scheduled follow-up appointments was poor, regardless of age.

Oral contraceptives and breast disease.

Epidemiologic data support the hypothesis that the types of OCs used before the mid-1970s protected against most forms of benign breast disease. It is unclear whether current low-dose progestogen OCs will confer the same protection. Further studies are necessary to clarify this. For breast cancer, the relationship is more complex. It is possible that prolonged use of high-dose OCs exert a small increased risk for breast cancer development in women before age 45. Furthermore, prolonged use before a first term pregnancy may result in a small increase in risk for breast cancer before age 45. Studies evaluating the effect of current low-dose OCs are necessary to elucidate what, if any, effect they may have on breast cancer development. Furthermore, as our population ages, studies will be able to determine what effect, if any, may be present in women over age 60, those women with the highest underlying risk of breast cancer. And finally, more research of basic breast tissue physiology and the effect of endogenous and exogenous hormones on this complex organ is needed.

PIP: This review covers the epidemiology of benign and neoplastic breast disease, the theoretical effects of steroids on the breast, and the effects of oral contraceptives on both. Breast cancer has been increasing since the 1940s in older U.S. women, killing about 44,500 of the 175,000 new cases per year. In addition fibrocystic breast disease may affect up to 50% of premenopausal women, resulting in 500,000 biopsies, of which 10% are cancerous, 33% of those in post-menopausal women. The involvement of steroids in development of the human breast, and in breast cancer, is reviewed. The breast does not complete its development until the end of the 1st pregnancy. The terminal ductal cells, from which breast cancers form, are susceptible to stimulation by progestins in nulliparas. Progestins, at least in the high doses used in early orals, protect against benign breast disease. Inadequate amounts of progesterone, however, as in irregular cycles, seem to predispose to breast cancer. Epidemiologic studies of oral contraceptive use and breast cancer are reviewed under the studies of oral contraceptive use and breast cancer are reviewed under the headings of overall results, age, age 45, parity, use before 1st pregnancy, use at young ages, latent effect, hormone formulation, associated benign breast disease, association with other neoplasms, and receptor status. There are slightly increased risks for cancer before age 45 for long-term use of pills before the 1st term pregnancy, although the data are not wholly consistent, in that the specific sub-groups of women affected differ in different studies. There is no clear evidence for a latent effect, that is, appearance of cancer 20-30 years after stopping the pill. Nor is there evidence of breast cancer linked to any specific pill type, nor with benign breast disease, nor with endometrial cancer. The reason for rising breast cancer rates is still unknown. The absolute number of increased cases related to oral contraceptives is insufficient to affect national rates. It is possible that the inconsistent findings in epidemiological studies reflects use of high-dose pills in the 1960s and early 1970s. The contraceptive and non-contraceptive benefits of the pill are more important for women's health than the potential cases of breast cancer in young women who took them for prolonged durations.

Oral contraceptives and neoplasia: 1987 update.

PIP: This article reviews the research evidence on the relationship between oral contraceptives (OCs) and neoplasia. More recent epidemiologic studies in this area are considered to have greater validity than earlier studies, largely because of improved assessment of confounding factors. Encouraging has been the finding of a protective effect of OCs on endometrial and ovarian neoplasia: about 2000 cases of endometrial cancer and 1700 cases of ovarian cancer are averted in the US each year as a result of OC use. No consistent association, either adverse or beneficial, has emerged between OCs and breast cancer; however, high-dose combined OCs exert a protective effect on the development of benign breast disease after 2 years of use. Longterm combined OC use appears to be related to the development of benign liver lesions, but the research evidence on the association between OCs and hepatocellular carcinoma remains inconclusive. Of concern is the finding that longterm OC use is associated with an increased risk of cervical neoplasia. The mechanisms by which OCs might exert adverse effects on cervical epithelium are unclear.^ieng

Oral contraceptives and neoplasia.

PIP: Some of the available data concerning the suspected association between oral contraceptive (OC) use and the development of cancer is surveyed, and the attempt is made to evaluate possible associations between OCs and human neoplasia in light of pregnancy risk or benefit of oral contraception. The principal investigative methods in humans include various epidemiologic approaches, and the methodologies most often used are case reports (tumor registries), disease rates and trends, case-control studies, and cohort studies. These methods cannot prove a causal relationship between exposure to a possible carcinogen and the occurrence of disease. Consistent positive or negative evidence, confirmed by multiple epidemiologic approaches, can be used to guide physicians and regulatory agencies in formulating policy for the clinical use of OCs. Both the progestogen-only and the combined OCs have been shown to have a protective effect on the development of benign breast disease with this protective effect not appearing until 2 years of use. Long-term combined OC use appears to be related to the development of benign liver neoplasia, and this risk increases with the dose of the steroid and the age of the user. These lesions are quite rare but may be life threatening because of potential spontaneous rupture and hemorrhage. Long-term postmenopausal use of estrogens appears to increase significantly the risk of developing endometrial hyperplasia and adenocarcinoma of the endometrium. Estrogens appear to be related to the growth of pre-existing uterine leiomyomas. Endocervical cells under the influence of progestogens may develop adenomatous changes, and these benign changes have on occasion been misinterpreted as carcinoma.^ieng

Complications of female sterilization: immediate and delayed.

Surgical sterilization in women has changed dramatically over the past 20 years. The development of laparoscopy and minilaparotomy have made the procedure readily available even in developing countries. In the United States, changing social values and changes in hospital regulations have done as much as technology to account for the tremendous increases in the number of women undergoing sterilization. Improved sterilization procedures have resulted in lower costs for sterilization and lowered morbidity and mortality rates. Hysterectomy for sterilization alone carries unacceptable morbidity and mortality rates. Originally, laparoscopic techniques utilized unipolar cautery. However, bowel burns, a rare but serious complication, were reported, and this led to newer techniques. These techniques, using bands, clips, and bipolar cautery, have gained increasing popularity and have eliminated many of the serious complications of female sterilization. Historically, there has been concern that tubal sterilization by any method produces, in significant numbers of patients, the subsequent gynecologic and psychologic problems called "post-tubal ligation syndrome." A review of earlier literature indicates that many of these studies have serious methodologic problems, including recall bias, inappropriate control groups, failure to elicit prior history of gynecologic or psychologic problems, and failure to account for the use of oral contraceptives or IUDs. More recent large prospective epidemiologic studies that have controlled for prior gynecologic problems and contraceptive usage have failed to show increased incidence of gynecologic sequelae in large numbers of women. However, there are some data to support the concept that in certain individuals, sterilization may result in disruption of ovarian blood or nerve supply, producing gynecologic sequelae. Additional data from these ongoing large-scale studies and others should help to elucidate this problem in the future. Pregnancy after sterilization (even excluding pregnancies present at the time of the procedure) is more common the first year after the procedure with the risk decreasing in subsequent years.(ABSTRACT TRUNCATED AT 400 WORDS)

PIP: Surgical sterilization has changed dramatically over the past 20 years; the development of laparoscopy and minilaparotomy have made the procedure readily available even in developing countries. Improved sterilization procedures have resulted in lower costs for sterilization and lowered morbidity and mortality rates. Historically there has been concern that tubal sterilization by any method produces, in significant numbers of patients, the post-tubal ligation syndrome. More recent studies that have controlled for prior gynecologic problems and contraceptive usage have failed to show increased incidence of gynecologic sequelae in large numbers of women, but there are data to support the concept that in certain individuals, sterilization may result in disruption of ovarian blood or nerve supply, producing gynecologic sequelae. Data from the Collaborative Review of Sterilization (CREST) conducted by the Centers for Disease Control from 1978-81 are analyzed. Overall complication rates were 42.8% for abdominal hysterectomy and 24.5% for the vaginal procedure. Postoperative febrile morbidity was the most common complication but 0.8% of the abdominal hysterectomies and 1.6% of the vaginal hysterectomies required repeat exploratory operations. In another series of 5018 women 0.45% had bleeding complications during unipolar cautery, 0.29% required laparotomy. In a series of 846 silastic ring sterilizations, 3.1% had bleeding complications but only 2 of these required laparotomy and 1.6% had complications related to the ring technique. It was also shown by the CREST data that: 1) the use of an IUD 1 month prior to sterilization did not alter the risk of complications, 2) sterilization and removal of an IUD should not be performed at the same time, and 3) the risk of requiring laparotomy to complete the sterilization procedure is greater if the woman has a history of previous abdominal or pelvic surgery or obesity greater than 12% of ideal body weight. Pregnancy after sterilization is more common the 1st year after the procedure with the risk decreasing in subsequent years. 1st-year failures are about 0.18-0.37/100 women years and then fall off to 0.1--0.12/100 woman years in subsequent years. The ratio of ectopic pregnancy among these pregnancies is higher after laparoscopic cautery techniques. Band and clips may be slightly less effective than the use of electrocoagulation or the Pomeroy technique. Resection is associated with a slightly higer risk of mesosalpingeal bleeding.

Fertility after contraception or abortion.

There is a very small correlation, if any, between the prior use of OCs and congenital malformations, including Down's syndrome. There are few, if any, recent reports on masculinization of a female fetus born to a mother who took an OC containing 1 mg of a progestogen during early pregnancy. However, patients suspected of being pregnant and who are desirous of continuing that pregnancy should not continue to take OCs, nor should progestogen withdrawal pregnancy tests be used. Concern still exists regarding the occurrence of congenital abnormalities in babies born to such women. The incidence of postoperative infection after first trimester therapeutic abortion in this country is low. However, increasing numbers of women are undergoing repeated pregnancy terminations, and their risk for subsequent pelvic infections may be multiplied with each succeeding abortion. The incidence of prematurity due to cervical incompetence or surgical infertility after first trimester pregnancy terminations is not increased significantly. Asherman's syndrome may occur after septic therapeutic abortion. The pregnancy rate after treatment of this syndrome is low. The return of menses and the achievement of a pregnancy may be slightly delayed after OCs are discontinued, but the fertility rate is within the normal range by 1 year. The incidence of postpill amenorrhea of greater than 6 months' duration is probably less than 1%. The occurrence of the syndrome does not seem to be related to length of use or type of pill. Patients with prior normal menses as well as those with menstrual abnormalities before use of OCs may develop this syndrome. Patients with normal estrogen and gonadotropin levels usually respond with return of menses and ovulation when treated with clomiphene. The rate for achievement of pregnancy is much lower than that for patients with spontaneous return of menses. The criteria for defining PID or for categorizing its severity are diverse. The incidence of PID is higher among IUD users than among patients taking OCs or using a barrier method. The excess risk of PID among IUD users, with the exception of the first few months after insertion, is related to sexually transmitted diseases and not the IUD. Women with no risk factors for sexually transmitted diseases have little increased risk of PID or infertility associated with IUD use. There appears to be no increased risk of congenital anomalies, altered sex ratio, or early pregnancy loss among spermicide users. All present methods of contraception entail some risk to the patient. The risk of imparied future fertility with the use of any method appears to be low.(ABSTRACT TRUNCATED AT 400 WORDS)

PIP: This is a comprehensive review of the risk of infertility or adverse effects on pregnancy outcome, such as chromosomal or congenital birth defects, amenorrhea, pelvic inflammatory disease (PID), or spontaneous abortion, after use of oral contraceptives, IUDs, induced abortion or spermicides. The sequelae reported for orals are chromosomal abnormalities, the VACTERL anomalies, masculinization of female fetus, Down's syndrome and post-pill amenorrhea. Several large studies found no increased risks for birth defects, although the risk of malformations when pregnant women inadvertently take the pill in early pregnancy was high in 1 of 2 such studies. Masculinization was reported with high dose combined hormone treatment and in 2 infants of a woman who took Enovid. the bulk of recent studies on secondary amenorrhea indicate that it is rare, but just as likely to occur in women with prior normal or abnormal menstrual patterns. One study found that amenorrhea is 7.7 times more likely to develop in women who took the pill to regulate menses. It is recommended that women with amenorrhea be screened for pituitary tumors and counseled before prescribing pills, and that those who fail to ovulate after stopping the pill be treated at least 6 months with clomiphene. A massing of all studies on the impact of 1st trimester induced abortion on subsequent fertility, premature delivery and spontaneous abortion, shows all relative risks around 1.0. After multiple abortions, the results are conflicting. In contrast, prior series analyzing illegal abortion have an unquestioned adverse effect on fertility and pregnancy outcome. Asherman's syndrome, a rare disorder of intrauterine adhesions, menstrual abnormalities, infertility and habitual abortion, has been associated with D & C abortion concurrent with pelvic sepsis, or traumatic pregnancy with D & C. This condition can be treated with moderate success. The bulk of IUD studies conclude that there is no overall decrement in fertility, while some disaggregated studies point the Dalkon shield as a higher risk and copper IUDs as a lower risk. PID and its consequences are now considered related to the immediate post-insertion time frame, or specifically to women who are at risk of contracting sexually transmitted disease, i.e., those with multiple partners, those with prior PID and nulliparas. Comprehensive review of current large series on spermicides shows no relationship between their use and spontaneous abortion or congenital malformation.

Alterations in the organic compounds of vaginal secretions caused by sexual arousal.

The low-molecular weight organic constituents of human vaginal secretions from normally cycling subjects were analyzed both before and after sexual stimulation. Gas chromatography and combined gas chromatography-mass spectrometry were employed in the analyses of the secretions. Consistent increases were noted for a number of the lipid constituents of the secretions, suggesting that they are derived at least in part from the plasma and transude into the vaginal lumen during arousal. In addition, the increases in the concentrations of glycerol and stearic acid with respect to baseline levels were significant (P is equal to and less than 0.05). Compounds which are produced intravaginally appear to decrease in concentration during the arousal interval because of dilution by the transudate. No consistent qualitative changes were noted in the secretion.

Sexual behavior and steroid levels among gynecologically mature premenopausal women.

Twenty-seven gynecologically mature young women who participated in a 14-week study prospectively recorded daily sexual behavior and basal body temperature data. In addition, they supplied plasma three times during the last cycle of participation. Plasma was analyzed for estradiol (E2), testosterone (T), and progesterone (P) by radioimmunoassay. The levels of circulating sex steroid hormones during the luteal phase were examined in relation to measures of menstrual cycle length, sexual frequency, and coital total. The results indicated the following: (1) women who had weekly sex with men had higher levels of estrogen than women who did not; (2) total amount of coital behavior was not related to any of the hormones assayed; (3) neither T nor P were distinguished by the consistency of sexual behavior or by coital total; and (4) women with aberrant-length cycles tended to have lower levels of E2. Thus, E2 consistently showed relationships to sexual behavior and cycle length, whereas P and T did not.

A synthetic steroid (R2323) as a once-a-week oral contraceptive.

Five milligrams of the steroid R2323 (13 beta-ethyl-17 alpha-ethynyl-17-hydroxygona-4,9,11-trien-3-one (R2323) were administered orally once weekly to 28 subjects for a total of 138 treatment cycles. No pregnancies occurred. The predominant side effects were irregular vaginal bleeding, headache, weight gain, and acne. Administration of the drug was stopped by the investigator in four patients (14%) because of the onset of headaches. Four patients discontinued the drug for other reasons. In 8 of 26 subjects (31%), endometrial biopsy in the third treatment cycle showed secretory endometrium. This suggests a variable central suppression with the 5-mg dose schedule. Patients were enthusiastic about the once-weekly oral administration. This contraceptive may be useful in a select group of women.

Physiologic and psychologic profiles in a survey of women runners.

The purpose of the present study is to report physiologic and psychologic factors in a survey of women runners. Psychologic factors were used in an investigation of differences in perceived emotional distress within a group of women runners. The psychologic information was compared with the results of two groups of infertility patients and a group of fertile control subjects. Among the physiologic factors, there was a significant difference in the mean weight and the height/weight ratio between amenorrheic and regularly cycling runners (P less than 0.001) and amenorrheic runners and runners with irregular cycles (P less than 0.01). The psychologic data showed no difference between runners and fertile control subjects. When runners were divided according to menstrual intervals or miles run per week, there were differences in perceived emotional distress.

Cost-effectiveness of treatment for drug-abusing pregnant women.

Neonatal intensive care unit (NICU) and drug treatment costs were compared in two groups of pregnant drug abusing women: 100 admissions to a multidisciplinary treatment program and active in care at the time of delivery and 46 controls not entering drug treatment. Clinical measures included urine toxicology at delivery, infant birthweight. Apgar scores and need for and duration of NICU services. Cost measures included drug treatment and NICU costs. Treatment patients showed better clinical outcome at delivery, with less drug use and higher infant estimated gestational age, birthweight and Apgar scores. Infants of treatment patients were also less likely to require NICU services and, for those that did, had a shorter stay. When total cost was examined (including drug treatment), mean net savings for treatment subjects was $4644 per mother/infant pair. The study demonstrates the cost-effectiveness of treatment for pregnant drug abusing women, with savings in NICU costs exceeding costs of drug treatment.

Buprenorphine treatment of pregnant opioid--dependent women: maternal and neonatal outcomes.

This open-label prospective study examined maternal and neonatal safety and efficacy outcome measures during and following prenatal buprenorphine exposure. Three opioid-dependent pregnant women received 8 or 12 mg sublingual buprenorphine tablets daily for 15-16 weeks prior to delivery. Results showed that buprenorphine in combination with comprehensive prenatal care was safe and effective in these women. Prenatal exposure to buprenorphine resulted in normal birth outcomes, a mean of 4.33 days (minimum possible=4) hospitalization, and a 'relatively mild' neonatal abstinence syndrome comprised primarily of tremors (disturbed), hyperactive moro and shortened sleep after feeding. The infants required no pharmacological treatment. Onset of neonatal abstinence signs occurred within the first 12 h after birth, peaked by 72 h and returned to below pre-12 h levels by 120 h. It is concluded that buprenorphine has potential utility for the treatment of pregnant opioid-dependent women.

Sexual behavior frequency and biphasic ovulatory type menstrual cycles.

College students whose menarche had occurred 7 years previously, prospectively recorded menstrual and sexual behavior history for 14 weeks as well as basal body temperatures. Regular weekly coital activity associates with the highest incidence of fertile type cycles in this sample of young women as follows: (1) Regular weekly heterosexual behavior was associated with 29.5 +/- 3 day menstrual cycle length. Less frequent sexual activity (sporadic) and celibacy were associated with an increased frequency of aberrantly short and long cycle lengths. (2) Either of two heterosexual behaviors (coitus and/or genital stimulation by a man) were behaviors which were adequate as associates of 29.5 +/- 3 day cycles. (3) Self-stimulation (masturbation to orgasm) was inadequate as an associate of the above-described pattern of menstrual cyclicity. (4) Women with regular weekly coital activity had the highest incidence (90%) of fertile type basal body temperature (BBT) rhythms. Sporadically active women had the next highest incidence (55%) of fertile type BBT rhythms. Celibate women had the lowest incidence (44%) of fertile type BBT's.

Preliminary experience with Norplant in an inner city population.

Norplant, the five-year subdermal contraceptive system, is the first implantable contraceptive method approved for general use in the United States. We describe the preliminary experiences of 246 U.S. women who accepted Norplant between April, 1991 and September, 1991. Norplant was well accepted among this diverse general population. Intensive counselling about side effects, especially menstrual changes, is crucial for patient satisfaction. Although 48% of acceptors experienced menstrual cycle changes and 70% experienced at least one side effect, phone calls and unscheduled visits for problems were infrequent. Adequate counselling about side effects obviates the need for a routine follow-up visit one month after insertion.

PIP: Between April and October 1991 in Baltimore, Maryland, family planning providers tried to follow 246 13-42 year old women at a clinic at the Francis Scott Key (FSK) Medical Center for 3 months who accepted the levonorgestrel-releasing implant Norplant to evaluate its acceptability and effectiveness among a high-risk population. 56% of the women were Black and 41% White. 69% were single. Most were interval gynecologic patients (109), but many were postabortion patients (97). The providers could only follow 108 women. Reasons for unscheduled visits were insertion site tenderness, amenorrhea, and removal. At 1 month, 70 % had at least 1 side effect. 48% had irregular bleeding 1-2 months after insertion. Other side effects included headache (49%), acne (24%), weight gain (22%), increased appetite (19%), and dizziness (18.5%). The 24-hour telephone hotline had only received 38 problem calls, all of which were from FSK Norplant patients. More than 50% of the calls were about menstruation concerns. Reasons for removal included pressure to receive Norplant, increased acne, headaches and prolonged bleeding, and postinsertion site problems. 1 woman became pregnant, but it occurred before insertion. She underwent an abortion and continued to use Norplant. 78% of the women considered Norplant to be excellent and 14% considered it to be good. 95% would recommend it to others. 69% reported convenience to be the best thing about Norplant and 22% said it was pregnancy prevention. Worst things were irregular bleeding (26%) and progestin-related side effects (e.g., headaches and weight gain) (19%). 35% did not consider anything to be bad about Norplant. 64% had at least some apprehension before insertion, the major reasons being fear of needles (48%) and of pain (37%). Prior to insertion, just 37% were worried about potential side effects. The providers thought that the routine follow-up visit at 1 month was not cost-effective and provided no specific clinical benefit. They advocated adequate counseling about side effects to take the place of the follow-up visit.