Physicians who provide care for adolescents are well positioned to help prevent the negative consequences of sexual activity--unintended pregnancy and sexually transmitted diseases. Physicians should look for opportunities to emphasize the advantages of postponing sexual involvement. Nonetheless, we should recognize that few adolescents come to us seeking opinions about their sexual behavior. Instead, they come for information on contraception and STDs. In caring for sexually active teens, therefore, our role should be to encourage responsible sexual behavior, not to moralize about it. Countries such as Holland, a society which focuses on providing health services for sexually active teens rather than value judgments, has achieved rates of pregnancy and abortion remarkably lower than those experienced by U.S. adolescents. Although oral contraceptives (OCs) are well tolerated by most teens, achieving OC compliance and continuation represents a major challenge for many teenage patients. Often, use of the long-acting hormonal methods Depo-Provera or Norplant represents a more practical approach to achieving effective contraception for teenagers. Initial experience in the United States suggests that teens appreciate the freedom from daily compliance provided by these long-acting hormonal methods. Practical issues relative to achieving patient satisfaction and effective, safe contraception will be reviewed with respect to Depo-Provera, Norplant and OCs. Because STDs occur so frequently in teens, the "belt and suspenders" approach to contraception often makes sense: hormonal contraception plus condoms. Many would agree with the comment: "It's no longer diamonds. Now, condoms are a girl's best friend." Physicians who focus on health care rather than moral issues can still encourage responsible behavior and improve health outcomes in this important group of patients.

Norplant is a pure progestative method which couples efficaciousness, reversibility and a period of prolonged action. We have counted 189 insertions since March 1993, the date of the introduction of this contraceptive method in the center of family planning at the university maternity of Orangers. The analytical study of different parameters collected in admission files and preestablished control allowed to draw the epidemiologic profile of the patients as well as acceptability, the tolerance and the efficiency of this method.

A total of 1473 Norplant users in the countryside of Sichuan Province were investigated to present a multivariate analysis of satisfaction, side effect, and efficacy for Norplant. The results showed that contraceptive efficacy rate, continuation rate, prevalence rate of side effects and satisfactory rate were 99.3%, 90.6%, 86.4%, and 69.7%, respectively. The logistic regression analysis showed that the variables significantly contributing to satisfaction were the user's knowledge about Norplant, the user's voluntary choice of Norplant, and the spouse's satisfaction. The satisfaction was associated with continuation and the prevalence of side effects. It is concluded that Norplant is efficacious and satisfactory to a certain extent among the users in rural Sichuan; its continuation rate is high but the prevalence of side effects is noticeable. For the wide application of Norplant in the countryside, it is important to strengthen propagation and education.

BACKGROUND

This study describes the Norplant prescribing experience, training, and attitudes of South Carolina family practice and general practice (FP/GP) physicians.

METHODS

A survey was mailed to all FP/GP physicians licensed in South Carolina, with two follow-up mailings to nonrespondents.

RESULTS

Responses were received from 520 physicians, representing 43% of all licensed FP/GP physicians and 73% of all board-certified FP physicians. Norplant had been inserted by 39% of the respondents, and fewer than 10% reported encountering complications during the insertion process. Norplant removal was reported by 135 physicians, averaging 4.4 removals per year. Complications during removal were reported by 52% of physicians, with the most common problem being difficulty finding the capsules. Some degree of training in Norplant insertion was reported by 82% of physicians; 69% reported having had some training, formal or informal, in removal; but only 57% reported having received formal training either during residency or at a workshop. Training reduced insertion time but did not affect removal time or the number of complications encountered. Formal training was more likely to prepare physicians to successfully manage procedural complications.

CONCLUSIONS

FP/GP physicians are important providers of Norplant. Improved training is needed to ensure that insertion is performed properly and to disseminate effective removal techniques.

Many concerns have been expressed regarding the introduction of a new contraceptive method into family planning programmes. One of the concerns is the return of fertility after discontinuing the method. To evaluate the subsequent fertility status of the Indonesian women after removal of Norplant, a prospective longitudinal study was undertaken in Klinik Radeb Saleh, Jakarta. Fifty-one women whose Norplant were removed because of their wish to become pregnant were followed-up for a period of two years or until pregnancy occurred, whichever was earlier. Two groups of women who had Lippes C IUD removed or discontinued the use of DMPA for planning pregnancy served as control and were followed-up for equal length of time. The cumulative conception rate for ex-Norplant users, ex-IUD users and ex-DMPA users at one year was 76.5, 74.7 and 70.2 per 100 women, respectively. There was no significant difference between the groups (p greater than 0.05). The present study, along with other studies, indicate that the prolonged use of Norplant do not impair the return of fertility.

A women-centered contraceptive research agenda was the focus of a 1996 Institute of Medicine Committee report. Priority was given to research on methods that act as a chemical or physical barrier to conception and to STDs including HIV; to menses inducers and once-per-month methods; and to male contraceptive methods. Much progress has been made since the 1996 report. This paper summarizes this progress. New research has been developed in the three priority areas, collaboration activities have been developed between the public and private sectors, and emergency contraception has been introduced to the US. Controversies are discussed in relation to immunocontraception, stem cell research and fetal tissue research. Finally there is a brief report on the lessons to be learned from the experience of the introduction of the implant, Norplant, in the US.

Norplant-2 contraceptive implants consist of two Silastic rods in which levonorgestrel has been incorporated with the polymer. This on-going study describes our two-year experience with 100 acceptors of Norplant-2 rods in Singapore. No pregnancies occurred during the first two years of use. Desire for planned pregnancy and menstrual irregularities accounted for 86.4% of the removals during this period. The continuation rate at the end of two years was 78%. The post-removal conception rate in women desiring planned pregnancy was 54.5% at the end of one year. Apart from this apparent slow return of fertility requiring future close surveillance, it appears that the Norplant-2 rod system offers a highly effective and convenient means of contraception.

Norplant contraceptive implants are Silastic containing levonorgestrel implants. This study describes our two-year experience with 100 acceptors of Norplant implants in Singapore. No pregnancies occurred during the first two years of use. Desire for planned pregnancy and disruption of menstrual rhythm were the two main reasons for twenty implant removals during the two years. The continuation rate at the end of two years was 79%. The post-removal conception rate in women desiring pregnancy was 90% at the end of one year. It thus appears that the Norplant contraceptive system offers a highly effective, acceptable, reversible and safe method of contraception.

A three-year clinical evaluation of Norplant-2 rods in Singapore shows that no pregnancy occurred during the three years of use. The continuation rate at the end of three years was 74%. Desire for planned pregnancy was the main reason for removal during the three years. The post-removal conception rate in women desiring planned pregnancy was 50.0% at the end of one year. This low rate could be attributed to the four women deciding against a pregnancy after removal. However, despite this apparent reason one needs to monitor the post-removal return of fertility closely in the years to come.

The Norplant-2 rod system consists of two silastic rods in which levonogestrel has been incorporated with the polymer. The continuation rate at the end of five year was 62%. No accidental pregnancies occurred throughout the five years of use. The post-removal conception rate in women desiring pregnancy was 70.8% at the end of two years. The majority of acceptors were happy with the rods and 86.8% expressed the desire to have another set of implants inserted following removal of the first set. The study shows the Norplant-2 rod system to be a well accepted method of family planning.

A three-year clinical evaluation of Norplant implants in Singaporean acceptors shows that no pregnancy occurred during the first three years of use. The continuation rate at the end of three years was 69%. Desire for planned pregnancy and disruption of menstrual rhythm were the two main reasons for implant removal during the three years. The post-removal conception rate in women desiring pregnancy was 94.1% at the end of one year. It thus appears that Norplant offers a highly effective, safe, acceptable and reversible method of contraception.

The mean of the Norplant usage period of 338 acceptors was 44.4 months. Most users had poor education and low incomes; the lower their socioeconomic status, the longer they used the Norplant implant. Return to fertility 3 months after removal was 38.46%; after 6 months, 71.43%; after 9 months, 74.46%; and after 12 months, 75%. The continuation rate at year one was 82.84%; year 2, 74.85%; year 3, 68.34%; year 4, 64.79%; while year 5 was 8.58%. The mean removal time was 21 minutes. There was a very significant difference between trained and untrained removers in the duration of removal. The average number of capsules removed was 5.64. There was no significant difference between trained and untrained removers in successful capsule removal. Reasons for removal were expired date and non-medical complaints such as changing to other contraceptives and the wish to become pregnant; medical complaints were dizziness, vertigo, spotting and amenorrhea. Removal was prompted by acne, metrorrhagia, two or more medical complaints, menorrhagia, physical pain, tenderness at insertion site and spotting. There were no pregnancies found among acceptors. However, 5.92% of the acceptors were pregnant at the time of insertion because of misdiagnosis. It can be concluded that Norplant is effective, safe and acceptable but removal needs trained persons.

There is an emerging policy debate over the inclusion of Norplant incentives in welfare reform. Even if women were guaranteed access to the implant and payment for its removal were assured, the possibility of increased human immunodeficiency virus infection would remain a strong argument against its use. Although this article focuses on Norplant, many of the arguments apply to other long-acting contraceptives that may become available in the future.

The study was carried out by the Human Reproduction Research Centre of the Indian Council of Medical Research at Lucknow and Kanpur, India as part of a multicenter study to ascertain the oncogenic potential of Norplant-I, a progestational contraceptive, by periodic cytological evaluation of cervical smears. In total, 278 fertile healthy women were inserted with Norplant-I at the Contraceptive Clinic of the Department of Obstetrics and Gynaecology of K.G.'s Medical College, Lucknow and G.S.V.M. Medical College, Kanpur, were and followed for periods ranging from 1-5 yr. It was reassuring to note that squamous intraepithelial lesion (SIL) incidence was found to be significantly higher only in the initial stages of contraception after 1 yr of Norplant insertion, after which it declined; no SIL was seen after 3 yr of contraception. The retrogression of SIL was also seen in all 11 pre- and 15 of 18 postinsertional cases. As SIL incidence showed a rise with increasing age and parity, the study also highlighted the need for constraint in offering Norplants to women of high age and parity. The percentage of inflammatory smears were also high till 4 yr of Norplant use, warranting a need for adequate treatment and early repeat cytology to exclude the persistence of inflammation. The accumulated data indicate the safety of long-term use of Norplants upto 5 yr, as far as oncogenic potential is concerned.

Objective: This paper focuses on the user profile, side effects, and discontinuation rates of Depo-Provera users at Grady Memorial Hospital, a large inner-city hospital in Atlanta, Georgia.Methods: Between July 1993 and April 1996 baseline and follow-up interviews were conducted with African-American and Caucasian women who were using a contraceptive method. Women had to choose a method that they had not used in the previous 3 months.Results: Depo-Provera was one of the top two contraceptive methods chosen at Grady Memorial Hospital. Convenience and effectiveness were the main reasons for its selection. Of the total Grady Hospital sample (n = 1,346), 404 women (30%) selected Depo-Provera as their method of contraception. Approximately 70% of the Depo-Provera users were aged 16-25 years, African American (98.3%), had never been married (88%), were on Medicaid (73.5%), and had had at least one pregnancy (94.3%). Depo-Provera users experienced menstrual (92.6%) and non-menstrual (67.6%) side effects. Menstrual side effects included amenorrhea, irregular cycles, spotting, and long menses. The most prevalent non-menstrual side effects were weight gain and headaches.The 12-month discontinuation rate of Depo-Provera was 49.2%, compared to oral contraceptives (66%) and Norplant (15%). The main reason cited for discontinuation of Depo-Provera was non-menstrual side effects (35.6%), menstrual side effects (23.1%), and inconvenience (12.0%). Of all women who initiated Depo-Provera use, 11.0% were pregnant at 12 months and 16.5% became pregnant by the first follow-up survey (average of 17 months).Conclusions: At Grady Memorial Hospital, Depo-Provera was a popular birth control method with high discontinuation rates. Menstrual, non-menstrual side effects, and inconvenience were the chief discontinuation factors. The impact of Depo-Provera discontinuation upon the pregnancy rate is substantial.

BACKGROUND

Norplant is the registered trade mark of the population council for contraceptive subdermal implants. Norplant implant contraceptive consists of six capsules containing progestin levonorgestrel. Each capsule is 3.4cm long and 2.4mm in diameter and contains 36mg of levonorgestrel crystals packed into a silastic capsule.

OBJECTIVE

The aim of this study was to evaluate the effect of Norplant implant use on weight, packed cell volume and describe the menstrual pattern observed during the period of use.

METHODS

This was a prospective study that involved 59 clients who had complete records at one year out of 71 informed volunteers recruited from the family planning unit of the University of Ilorin Teaching Hospital Ilorin from 1st March, 2002 to 31st December, 2003. Data on their weights packed cell volume and menstrual events were analysed at 3, 6, and 12 months of study.

RESULTS

The mean age(years) and parity of new Norplant implant acceptors during the period of study were 36. 15.6 and 3.9 1.5 respectively. The mean weight (kg) at pre-insertions was 66.5 [10.7] and 67.8 [10.7] and 68.9 [10.5] at 3, 6 and 12 months of Norplant implant use. The analysis of variance did not show statistical significant difference (P < 0.551) in the mean weight measured at pre-insertion 66.5 compared to the weight at 3, 6 and 12 months of Norplant use. The mean packed cell volume estimation (%) at pre insertion was 36.6 3.7 and had a statistical significant (p 0.003) rise to mean values of 37.3 3.4, 38.2 3.4 and 38.8 2.4 at 3, 6 and 12 months of Norplant use. The mean packed cell volume estimation (%) at pre insertion was 36.6 3.7 and had a statistical significant (P 0.003) rise to mean values of 37.3 [3.4], 38.2 [3.4] and 38.8[ 2.4] at 3,6 and 12 months of Norplant use respectively. Amenorrhea was the commonest observed menstrual change during the period of study. All acceptors were recruited with normal menstrual flow and at the end of the twelve months study period only 3 (5.1%) were still experiencing normal menstrual flow and 40 (67.8%) were amenorrheic.

CONCLUSIONS

Norplant Implant use was beneficial in maintaining weight and improving the packed cell volume ofusers. The menstrual change observed was tolerable.

It is a prospective study for the evaluation of the efficiency and the acceptability of Norplant contraceptive subdermal implants within the Senegalese female population. Three hundred women were selected on the basis of precise criteria between December 1986 and July 1991. Every patient included in the study signed a form of voluntary consent with the agreement of the consort, and was bound to come to control examinations until the removal of the implants. The insertion was made under local anaesthesia between the 1st and the 7th day of the cycle, or starting from the 6th week of post-partum in the other cases. The average age of patients was 32, and the average parity four children. 50 percent of women did not want any other children. The average insertion time is 4.8 minutes. The analysis of side-effects on 248 regularly followed women mostly reveals menstrual troubles like amenorrhea, spottings, menorrhagia. The fitful local prurigo was noted in 35 cases, and accidental pregnancy in 4 cases. The removal of implants within the first six months was made on 11 women (4.4%). As such, the Norplant implants constitutes a highly efficient method, well tolerated by Senegalese women.

A total of 55 non-breastfeeding informed volunteers were recruited into a prospective longitudinal study from a family planning clinic between September and December 2002. Blood samples were collected at pre-treatment and at 3, 6 and 12 months follow-up, for packed cell volume, platelet count, prothrombin and activated partial thromboplastin time. Statistical analysis was with paired t-tests. The level of significance was set at 5%. Each subject received a menstrual calendar to chart all bleeding and spotting events. The mean age and weight of acceptors were 32.5 +/- 6.1 years and 63.6 +/- 9.6 kg, respectively. Mean packed cell volume (PCV) was 35.2 +/- 2.9% at pre-insertion. This rose to significant mean +/- SD values of 36.5 +/- 3.1%; p<0.05, 38.5 +/- 2.8%; p<0.0001 and 38.4 +/- 3.6%; p<0.0001 at 3, 6 and 12 months, respectively when compared with the pre-insertion mean value. The mean values of the platelet count showed no significant change at 3 months (238,448 +/- 68,618 mm(3); p>0.9), compared with pre-treatment value (240,545 +/- 96,769 mm(3)). There was a significant reduction in mean concentration at 6 months (p<0.009; 191,364 +/- 55,531 mm(3)) and at 12 months (p<0.003; 202,773 +/- 81,544 mm(3)) follow-up. The prothrombin and the partial thromboplastin time did not show significant change over their pre-insertion mean values of 12.0 +/- 1.1 s and 36.9 +/- 2.9 s, respectively. At 12 months, 79.5% (35) of the users reported an abnormal menstrual pattern, which included 54.5% (24) reduced bleeding pattern, 20.5% (9) increased bleeding and 4.5% (2) of combination of patterns. Only 20.5% (9) had a normal menstrual pattern. The continuation rate was 98%, as one user discontinued because of headaches. Norplant (the registered trademark of the Population Council for levonorgestrel subdermal implants) had an effect on the bleeding pattern - mainly reduced bleeding. The increase packed cell volume is beneficial in preventing anaemia. There was no detrimental effect as a result of the reduced but normal platelet count and users were not predisposed to clotting abnormalities.

This ongoing prospective longitudinal study involved 23 women who had complete records, of 37 healthy non-breastfeeding informed volunteers recruited from our family planning clinic since August 1997 to the Norplant training programme. Packed cell volume (PCV), white blood cell (WBC) concentration (total and differential and platelet concentration were analysed at pretreatment and at 12, 24 and 36 months' followup. Statistical analysis was with paired t-tests. The level of significance was set at 5%. Each acceptor received a menstrual calendar to document all events of bleeding. The mean PCV was 40.5 +/- 2.4% at pretreatment. This rose to a statistically significant (P < 0.001) mean value of 44.9 +/- 4.4% at 36 months. The mean WBC concentration at pretreatment was 5552 +/- 1423 per mm3 which declined statistically (P < 0.001) to a mean value of 4400 +/- 1281 per mm3 at 12 months without any further significant changes at 24 months (P>> 0.6; 4143 +/- 1301 per mm3 and at 36 months (P>> 0.9; 4070 +/- 875 per mm3). At 24 months of study the mean concentration of neutrophils, lymphocytes, monocytes eosinophils and basophils did not change significantly from their respective mean concentrations at 12 months. These insignificant changes were also manifested at 36 months of study in the lymphocytes (P>> 0.2), eosinophils (P>> 0.5) and basophils (P>> 0.2), even though there was a significant decrease in the neutrophils (P < 0.05) with a corresponding significant increase (P < 0.001) in the monocyte concentration. However, there was still a significant decrease (P < 0.001) in the WBC at 36 months of study compared with the mean preinsertion value, which was manifested mainly in the neutrophil concentration (1403 +/- 517 per mm3 (P < 0.001). The mean value of platelet count (136260 +/- 27664 per mm3) at 24 months showed no significant change compared with the 12 months value (126174 +/- 37977 per mm3). The value at 36 months (125391 +/- 18858 per mm3), however, still showed a significant decline over the pretreatment mean concentration (208043 +/- 27250 per mm3). None of the acceptors had thrombocytopenia at 24 and 36 months. At 2 years and 3 years of studies 60.9% and 47.8% of Norplant users reported irregular bleeding patterns, mainly of reduced episodes. The continuation rate at 36 months was 100%. Women using the Norplant implant are at an advantage, because in spite of the variable aberrations in their menstrual pattern, the packed cell volume increased. The changes ob-served in the white cell and the platelet concentrations did not lead to adverse effects.

Twenty-one women who were consecutive acceptors of Norplant were recruited for this study in our centre in August 1997. The patients had baseline (pre-insertion) investigations including a standard oral glucose tolerance test (OGTT). At their regular 3, 6, and 12 months follow-up visits, the OGTT was repeated and results were analyzed. The mean age of the clients was 31.3+/-4.51 years (range 24-40 years). The mean weights were 61.60+/-11.35, 57.63+/-7.51, 62.60+/-11.98, and 62.17+/-11.56 kg at pre-insertion, 3, 6, and 12 months follow-up visits respectively. The differences were statistically insignificant. All OGTT values at pre-insertion and at the follow-up visits were within the normal range. However, in comparison to pre-insertion levels (4.00+/-0.10 mmol/L), the fasting blood glucose concentration at 12 months (3.39+/-0.12 mmol/L) showed a statistically significant decline (p <0.001). The area under the glucose curve (AUC) rose by 5.8% (p = 0.018) at 3 months but declined by 5.8% (p = 0.110) and 7.3% (p = 0.103) at 6 and 12 months, respectively. The peak pre-insertion plasma glucose level following OGTT occurred at 30 min. At 3 months, the peak OGTT glucose level occurred at 30 minutes and plateaued until 60 min while at 6 and 12 months this occurred at 60 and 90 minutes, respectively. The overall trend of OGTT results within the study period showed that 12 months of Norplant use in Northern Nigerian women has no detrimental effect on glucose metabolism.