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Introduction of Norplant implants in four counties of rural China: a two-year evaluation.

This article describes the first two years of Norplant implants use among 1560 acceptors in four counties of rural north China. Continuation of use was high, 88.4% after two years. Disruption of the menstrual cycle was the predominant side effect and the predominant reason for termination. Clinical performance among the four counties was diverse, with two-year continuation rates ranging from 73.9% to 95.3%. Factors that may contribute to the diversity among study sites and the overall high continuation rate are discussed in the context of Chinese family planning.

Adult↗

Cervical cancer screening continues to limit provision of contraception.

PURPOSE: Balancing needs for contraception and cervical cancer screening is challenging for clinicians. We assessed US obstetrician/gynecologists' practices regarding requirement of Pap testing before prescribing oral contraceptive or emergency contraceptive pills. METHODS: Questionnaires structured as clinical vignettes describing women desiring contraception with different risks of cervical dysplasia were mailed to a national sample of 355 obstetrician/gynecologists. RESULTS: A minority (3%) of the 185 obstetrician/gynecologists who responded would refill 12 months of oral contraceptives without requiring Pap testing. However, most would provide a limited supply of oral contraceptives until Pap testing could be performed. A substantial proportion (11-16%) would refuse to prescribe emergency contraception to women who they felt required Pap testing. Younger physicians, those practicing in academic settings and those who follow American Cancer Society guidelines were more willing to prescribe contraceptives without Pap testing. CONCLUSIONS: Cervical cancer screening continues to limit prescription of routine and emergency contraception by many US obstetrician/gynecologists.

Contraception↗

Depo-provera: an excellent contraceptive for those who continue to use it.

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.

Journal Article↗

Experience with the copper 7 intrauterine device in an adolescent population.

A retrospective study was conducted of 120 consecutive patients who received a Cu-7 IUD at the Cincinnati Adolescent Clinic during a four-year period from July, 1974, through June, 1978. Follow-up was obtained in 116 (97%) of the initial patient population. Mean age at initial Cu-7 insertion was 16.8 years; 81% of the patients were nulliparous. An experience of 149.7 women years was accumulated; the pregnancy rate at the conclusion of the study was 2.0/100 women years. Continuation rate was 83% at six months, 70% at 12 months, 49% at 24 months, and 39% at 36 months. Patient expulsion rate was 18% overall, with a total of 17 expulsion events/100 woman years. Subjective satisfaction with the IUD as a contraceptive method was expressed by 72% of these patients. The Cu-7 has proven to be a safe, effective, well-tolerated contraceptive method in the adolescent female.

Adolescent↗

[Continuous use--the important trend of combined hormonal contraception].

OBJECTIVE: Review of literature concerning continuous regimen of combined hormonal contraception. DESIGN: Review article. SETTING: Department of Obstetrics and gynecology, Charles University, Prague. METHODS: Review and critical assessment of published data. CONCLUSIONS: Attitude of gynecologists and women toward continuous use of combined hormonal contraception was liberalized within the last 15 years. Continuous regimen is well tolerated; number of spotting and bleeding days is increased in the first two cycles, with a substantial decrease afterwards. Total number of bleeding days is significantly lower in comparison to cyclic regimen. Continual use is not accompanied by any known health risk for users. Moreover, there are a few medical indications for such regimen.

Contraceptives, Oral, Combined↗

Efficacy and continuation rates of Norplant in Pakistan.

A total of 265 women who had the Norplant system inserted were followed for 5 years. The present study is based on 11,435 women-months of use, describing the continuation rates and efficacy of Norplant among these women. The 5-year cumulative continuation rate was 45.7 per 100 continuing users. The continuation rates were age-dependent. The women > or = 35 years of age consistently maintained higher continuation rates at all time intervals as compared with those of younger women. During 5 years of follow-up, five women became pregnant. Three pregnancies occurred in year 2, one in year 3, and one in year 5. The 5-year cumulative pregnancy rate was 2.5 per 100 continuing users. The weight of the user did not influence the pregnancy rate. The continuation rates, as well as the pregnancy rates, are comparable to those reported from other countries in the region.

Adult↗

A randomised trial and a comparative study of the copper 7 200 and the multiload copper 250 intrauterine devices.

A randomized trial of the Copper 7 200 (Cu 7 200) and the Multiload Copper 250 (ML Cu 250) intrauterine devices (IUD) was carried out for 13 months. On life table analysis at 12 months, net cumulative closure rates for use-related terminations (net rates) for the Cu 7 200 were higher than for the ML Cu 250 for accidental pregnancy (NS), expulsions (P less than 0.02) and medical removals for pain and/or bleeding (P less than 0.01). The continuation rate was lower for the Cu 7 200 (P less than 0.001). In a larger comparative study, at 12 months there was a highly significant difference (P less than 0.001) in favour of the ML Cu 250 in accidental pregnancy, expulsions and removals for pain and/or bleeding and continuation of use. Since the ultimate purpose of the use of an IUD is pregnancy protection with a minimum of side effects, the continued use of the Cu 7 200 is not recommended.

Clinical Trials as Topic↗

A comparative study of Norinyl 1/35 versus Lo-Ovral in Ile-Ife Nigeria.

A comparative analysis of those women on Norinyl 1/35 versus those on Lo-Ovral showed those on Norinyl 1/35 were significantly (P less than or equal to 0.05) older than women in the Lo-Ovral group. There were no significant differences (P greater than or equal to 0.05) between the groups for other characteristics at admission. There were no significant differences (P greater than or equal to 0.05) between the groups at follow-up in the number of women reporting serious complications, menstrual complaints or other pill-related problems. The continuation rates at 12 months were 79.4 for the Norinyl 1/35 group and 76.7 for the Lo-Ovral groups. There were no pregnancies reported during the study period.

Adult↗

[Clinical comparison of four types of IUDs made in China].

In order to compare the clinical efficacy of 4 types China made IUDs, this paper reported the study of a total of 1227 cases who, from January 1973 to June 1975, had used 1 of the 4 types of IUDs -- the stainless steel ring, metallic plastic mixed ring, metallic and silastic copper-shaped devices. The study was not a random allocation but was done, 1 type by 1, during the period. Life table method and logrank test were used to calculate and analyze the different events among these 4 types. 1147 cases were followed up for more than 5 years. The 5-year followup rate was 93.48%. Patients using these 4 types were comparable among themselves since the distribution of their age, gravida, para, and time of insertion were the same or quite similar. Study results were as follows: the cumulative pregnancy rates of the 2 copper V-shaped IUDs were significantly lower than that of the steel and mixed ring (p0.01); the cumulative expulsion rate of the steel ring was comparatively high, but there was no statistical difference compared with the others; bleeding was the main cause of medical removals; there was a higher cumulative medical removal rate of the V-shaped than that of the ring-shaped and also a significant difference between them (p0.01). However, at every year, the year-cumulative continuation rates were similar despite the difference of the events of discontinuation rates. The fact that 51.72-62.29% of the subjects continued to wear these IUDs indicated that the efficacy of the 4 types of IUDs was satisfactory even after a 5-year course.

Birth Rate↗

A five-year evaluation of NORPLANT II implants in China.

A five-year study of NORPLANT II rod implants was undertaken in four large cities and metropolitan areas in eastern China. Designed to test the safety, efficacy and acceptability of these implants, the study involved 1,208 women and was conducted concurrently with a similar study of NORPLANT capsule implants. At the end of five years, the gross pregnancy rate was 0.65 per 100, and the continuation rate was 65.3 per 100. Both these values were similar to and not statistically different from the rates of the capsule implant users. In 4,828 woman-years of use, there were few severe adverse events reported. Users and providers found the method to be an acceptable long-term contraceptive method of great reliability.

Adult↗

Comparative study on intermittent versus continuous use of a contraceptive pill administered by vaginal route.

A multicenter, international, randomized, comparative trial was conducted to assess the acceptability, efficacy and safety of two different schedules of a contraceptive pill, containing 250 micrograms levonorgestrel and 50 micrograms ethinyl estradiol, administered by the vaginal route. One schedule of daily administration for 21 days with a seven-day interruption to allow withdrawal bleeding was compared to daily administration without interruption for bleeding. A total of 900 women were recruited in three countries, Brazil, Egypt and China; 7,090 women-months of vaginal pill use were recorded (3,364 using the pills intermittently and 3,726 continuously). Four undesired pregnancies occurred, one in Egypt and three in China, all four in women using the pills intermittently. There was a statistically significant difference (p = 0.486) in pregnancy rate between the two groups. There were no other significant differences in discontinuation rates despite marked differences in bleeding patterns, amenorrhea predominating in the continuous use group. Hemoglobin levels increased significantly in the two groups but hematocrit was significantly higher in the continuous use group.

Administration, Intravaginal↗

A randomized, single blind comparative trial of norethindrone enanthate and depo-medroxyprogesterone acetate in Bangladesh.

A randomized, single blind comparative trial of norethindrone enanthate (NET-ENT) and depo-medroxyprogesterone acetate (DMPA) was conducted in the Model Clinic, Decca, Bangladesh, to determine if there were differences in reported side effects, reasons for discontinuation and discontinuation rates of these two injectables. On all follow-up visits the proportion of women reporting no bleeding (amenorrhea) was higher for the DMPA clients compared to the NET-ENT clients. Concurrent with these findings, the proportion of women reporting irregular bleeding was consistently higher for the NET-ENT clients. Concurrent with these findings, the proportion of women reporting irregular bleeding was consistently higher for the NET-ENT clients compared to those receiving DMPA. By the fourth injection, less than 15% of the clients in both drug groups still reported having regular cyclic bleeding (4 of the 26 DMPA clients and 4 of the 28 NET-ENT clients). Five of the 133 women on DMPA and 6 of the 106 women on NET-ENT became pregnant while using the injectables. At the end of one year of follow-up, 14 of the 133 DMPA and 14 of the 106 NET-ENT clients were still continuing (came back for a fifth injection).

Adult↗

[Copper-7 intrauterine device (Gravigard). Report of experience].

Within 2 years 258 women aged 16 to 42 years were fitted with a copper-7-IUD (Gravigard, Searle). 45% of these patients were nulliparous women. Follow-up studies were provided in 236 cases in a total of 2717 women-months according to an average time of observation of 11.5 women-months per patient. Altogether there occurred 5 unwanted pregnancies with a Pearl-Index of 2.3. Partial or total expulsion occurred in 27 cases (11%). Fourteen out of 27 expulsions were noticed within the first 2 months after insertion. Removals for medical reasons were requested in 36 cases-in the majority (26 cases) because of bleeding and pain. Thirteen women desired removal of the IUD in order to get either pregnant or sterilized. The continuation rate after 2 years was 73%. The highest number of drop-outs occurred within the first year after insertion (60 cases = 23%) whereas only 4% drop-outs occurred in the 2nd year. It was suggested that the low continuation rate might be partially due to the high number of physicians (19) participating in this study. The most important side effects of the copper-7-IUD in situ were irregular bleeding, intermenstrual pain and discharge. Irregular bleeding and pain decreased markedly after the first year, while slightly prolonged periods persisted in 30 to 50% of all patients. Compared with oral contraceptives copper IUDs hav less severe side effects but less safety at the same time-especially for the younger fertile age group. Therefore they should be offered to young nulliparous women only for a limited period of time.

Abortion, Spontaneous↗

Use-effectiveness and client satisfaction in six centers teaching the Billings Ovulation Method.

Use-effectiveness of the Billings Ovulation Method (OM) is reported for 1139 clients from six centers who were followed for at least 24 months. Method failure rates were 1% when calculated by either Pearl formula or life table analysis. Combined method and user failure rates were 20% when calculated with the Pearl formula, and 16% at 12 months and 23% at 24 months by life table analysis. Pregnancy rates were higher for couples using OM alone, than for couples using OM in combination with additional fertility awareness methods or together with barrier methods. The difference was significant when estimated by the Pearl formula but not when analyzed by the life table. The emotional implications underlying the apparent contradiction between a desire to avoid pregnancy and the deliberate coital use of fertile days are reflected in the differences between method and user failure rates, the high client satisfaction levels reported with "user failure," and 56% continuation rate at 24 months. The will require in-depth exploration.

Abortion, Legal↗

Acceptability of Norplant implants for fertility regulation in Singapore.

The continuation rate at the end of this five-year clinical study was 60% with no accidental pregnancy occurring throughout the five years. The post-removal conception rate in women desiring pregnancy was 92% at the end of two years. The majority of acceptors described the overall experience with the implants as favourable. In fact, 75% of the women planning to use contraception after removal of the implants were going to use implants again.

Adult↗

One-year clinical experience with FlexiGard.

In 1988, a clinical study with a new copper-containing IUD, the FlexiGard, was initiated at the Family Planning Center of the UMSD, Debrecen, Hungary. The aim of this trial was to measure the overall performance of the device with special attention to its frameless design and anchoring system. In one year (from May 1988 through May 1989), 344 FlexiGard devices were inserted in parous women during the first seven days of their menstrual cycle. This report summarizes the one-year results. By the end of the 12 -month follow-up period, 3484 woman-months of use (WMU) were accumulated. The number of women who completed the one-year follow-up period was 264. During this period, 33 cases were terminated for different reasons. The net continuation rate is 89.7 at the end of the first year of use. The device was well retained by the uterus (cumulative expulsion rate 1.5 at 12 months). The cumulative removal rate for bleeding/pain is 4.4 at 12 months and the cumulative pregnancy rate 0.6 at 12 months. The results confirm those of previously conducted multicenter studies with the device. This new generation intrauterine copper contraceptive (ICC) is well tolerated, which is attributed to its design characteristics. Besides, the device is highly effective, and its insertion is easy and safe. Removal of the ICC is equally easily accomplished.

Adolescent↗

The use of vaginal ultrasound to identify copper T IUDs at high risk of expulsion.

A total of 235 women who had a TCu 380A IUD inserted had a vaginal ultrasound scan performed to identify if the IUDs were correctly placed in the uterine fundus. Women identified as having a misplaced IUD had it removed. The remaining women were compared to 201 women who had an IUD inserted and had no ultrasound evaluation, matched by age and parity. Women were followed-up for one year. Gross cumulative discontinuation rates and continuation rates were calculated by life table analysis. Comparison between groups was done by the Gehan test. The study group had 34 IUDs removed because they were misplaced according to the established criteria. The expulsion rate was significantly higher in the control group, also influencing the continuation rate which was lower in the same group. Of the 34 women who had their IUD removed because it was not correctly placed, only 22 requested and had another IUD inserted. The removal of IUD determined by an ultrasound to be incorrectly placed significantly decreased expulsion rates. However, many IUDs may have been removed unnecessarily, probably resulting in many women not returning to the clinic or deciding to use another contraceptive method.

Adult↗

Natural family planning use-effectiveness and continuation.

Numerous studies have been conducted to assess the use-effectiveness of natural family planning. However, because of imprecise definitions of terms, these studies show noncomparable results. Special effort is required to study natural family planning use-effectiveness by the same criteria as other family planning methods.

Family Planning Services↗