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Biomedical subjects

G S Grubb

Publications and source records attributed to G S Grubb.

18 recordsLinked to original sources
PubMed1999

The effects of a low-dose monophasic preparation of levonorgestrel and ethinyl estradiol on coagulation and other hemostatic factors.

OBJECTIVE: This study was undertaken to evaluate the effects on hemostatic factors of a low-dose preparation of levonorgestrel and ethinyl estradiol in a 12-cycle study. STUDY DESIGN: Thirty healthy women began taking 100 microg levonorgestrel and 20 microg ethinyl estradiol on the first day of the menstrual cycle, continued to take the preparation for the next 21 days, and then took placebo for 7 days. Mean changes in prothrombin time, partial thromboplastin time, and levels of factors VII and X, antithrombin, plasminogen, fibrinogen, protein S, thrombin-antithrombin complexes, and D-dimer were analyzed at baseline and at cycles 3, 6, and 12 with paired Student t tests. RESULTS: Factor X, plasminogen antigen and activity, and D-dimer levels were significantly increased (P </=.01) during all 3 cycle periods. Antithrombin antigen and protein S total antigen levels were significantly (P </=.001 ) decreased at cycles 3, 6, and 12, whereas factor VII and protein S activity levels were significantly (P </=.05) decreased at cycle 3 and at cycles 3 and 6, respectively. CONCLUSION: The effects on hemostatic factors in healthy women of a monophasic preparation of 100 microg levonorgestrel and 20 microg ethinyl estradiol were similar to those of other low-dose oral contraceptives.

Adult↗
PubMed1999

Cycle control with oral contraceptives containing 20 micrograms of ethinyl estradiol. A multicenter, randomized comparison of levonorgestrel/ethinyl estradiol (100 micrograms/20 micrograms) and norethindrone/ethinyl estradiol (1000 micrograms/20 micrograms).

A randomized, open-label, multicenter study was undertaken to compare the effects of oral contraceptives (OC) containing 100 micrograms levonorgestrel (LNG)/20 micrograms ethinyl estradiol (EE) (Aless/Loette) and 1000 micrograms norethindrone acetate (NETA)/20 micrograms EE (Loestrin Fe 1/20) on menstrual cycle control over four cycles of use. A total of 84 evaluable women provided 274 cycles of exposure in the LNG/EE group, and 89 women provided 289 cycles of exposure in the NETA/EE group. Overall, the LNG/EE group achieved a consistently higher percentage of normal menstrual cycles as well as a lower rate of intermenstrual bleeding and amenorrhea than the NETA/EE group. In cycle 4, 63.8% of cycles were normal in the LNG/EE group compared with 41.9% in the NETA/EE group (p < 0.005). Of the total cycles in the NETA/EE group, 10% were amenorrheic, compared with 1.1% in the LNG/EE group. The occurrence of bleeding and/or spotting was significantly lower in cycles 2 and 3 in the LNG/EE group (41.7% and 34.8%, respectively) compared with the NETA/EE group (62.3% and 56.3%; p < 0.05). Other cycle variables were generally similar between groups, as was the incidence of adverse events. These results demonstrate that good cycle control was achieved with an OC containing 20 micrograms EE and that 100 micrograms LNG/20 micrograms EE produces better cycle control than 1000 micrograms NETA/20 micrograms EE.

Contraceptives, Oral, Hormonal↗
PubMed1997

Effect of vitamin B6 on the side effects of a low-dose combined oral contraceptive.

Analogous to recommendations for treatment of side effects of early pregnancy and premenstrual syndrome, use of vitamin B6 has been recommended for the treatment of side effects of oral contraceptive (OC) use. A randomized, triple-blinded controlled trial of 124 women was done to evaluate the effect of taking 150 mg of vitamin B6 daily for 30 days on the severity of nausea, headache, vomiting, dizziness, depression, and irritability associated with the initiation of low-dose (30 micrograms norgestrel and 30 micrograms ethinyl estradiol) OG use. The severity of the symptoms was measured on a scale from 0 to 3 (not present to severe), and was evaluated at one month after admission. The two treatment groups (vitamin B, and placebo) had comparable baseline characteristics. From admission to follow up, there was a decrease in the severity of all symptoms in both groups. There was no statistically significant difference in the reductions found in the vitamin B6 and the placebo groups, although reductions in the severity of headache and dizziness were greater in the B6 group. The decrease in the severity of all OC side effects can be explained more by a placebo effect than by a marginal pharmacological effect of the vitamin B6.

Adolescent↗
PubMed1995

Pre-introductory clinical trials of Norplant implants: a comparison of seventeen countries' experience.

This report summarizes the data collected in pre-introductory Norplant implants clinical trials in 17 countries in Latin America, Asia and Africa that were coordinated by either the Population Council or Family Health International (FHI) between 1984 and 1991. A total of 16,282 women between the ages of 18 and 40 years participated in the studies with semi-annual or annual follow-up visits for up to 5 years. Gross cumulative pregnancy rates were < 0.6 per 100 women in the first year and < 1.5 in the second year in all countries. Significant differences in cumulative 5-year pregnancy rates were observed between weight groups 40-49 and 50-59 kg and between 50-59 and 60-69 kg body weight but not between 60-69 kg and those > or = 70 kg. Total cumulative discontinuation rates after five years of Norplant implants use ranged from 35.8 to 60.0 per 100 women. Younger age and low parity were associated with a higher discontinuation rate. Cumulative discontinuation rates for menstrual reasons more than doubled between the end of the first year and second year of use in 13 of 17 countries. This analysis and one previous review provide the only comparison of Norplant contraceptive system study results across a wide diversity of countries; thus allowing an appreciation of the range of clinical experience with Norplant implants and the regional differences in that experience.

Adolescent↗
PubMed1993

A multicenter clinical trial of a progestin-only oral contraceptive in lactating women.

A non-comparative study of a progestin-only oral contraceptive (POC) containing 75 micrograms norgestrel was conducted at 22 sites in 14 countries. This study was designed to evaluate safety, contraceptive efficacy, and the overall acceptability of a POC in breastfeeding women. A total of 4,088 women entered the study over a three-year period and 29,399 woman-months of experience was gathered. Women had follow-up visits at 2, 6, and 11 months after admission. Headaches and vaginal discharge were the medical complaints most commonly reported by women, both prior to and after admission. Menstrual problems were reported by 59% of the women after admission. Of the 3,714 women who returned for at least one follow-up visit, 1,101 (29.6%) discontinued through month 11. The 11-month total discontinuation percentage, including those lost to follow-up (25.3%) was 51.6%. The most common reason given for discontinuation was a woman's desire for a change in contraceptive method. Only 4.9% discontinued pill use for menstrual problems, a percentage far below those generally reported for POCs. Twenty-nine unintended pregnancies occurred through 11 months giving a gross cumulative life table rate of 1.2 per 100 women (Pearl Index = 1.4). The POC appears to be a safe, effective and acceptable contraceptive option for postpartum breastfeeding women.

Adolescent↗
PubMed1991

Experimental methods of contraception.

While most new contraceptives currently in development incorporate existing contraceptive agents into new delivery systems, several types of contraceptives with novel mechanisms of action are making steady progress. The antiprogestin mifepristone (better known as RU 486) is being tested as an ovulation inhibitor, as a once-a-month pill, and as a postcoital contraceptive. An antiestrogen, Centchroman (Hindustan Latex, India), is in use in India as a once-a-week, nonsteroidal pill. The development of more potent pituitary gonadotropin antagonists has improved their potential to block ovulation in women and to inhibit spermatogenesis in men (which requires concurrent administration of testosterone). Another promising male contraceptive is an intraluminal vas occlusion plug tested extensively in China that can be removed with no apparent detriment to future fertility. Finally, several types of immunocontraceptives could become the most specific form of fertility control by directing an antibody response against the fertilized or unfertilized egg or against sperm.

Contraception, Immunologic↗
PubMed1990

Insertion site complications during the first year of NORPLANT use.

Although review articles have provided much information on the NORPLANT system, information on insertion site complications based on multi-country trials has been limited to infection rates. This paper examines 2,674 NORPLANT acceptors from seven countries who were enrolled and followed for one year. The one-year incidence rates of infection (0.8%), expulsion (0.4%) and local reaction (4.7%) varied widely among countries and clinics within a country. In contrast to previous reports that insertion site complications occur during the first few weeks of use, these data show that a substantial proportion of insertion site infections (34.6%) and implant expulsions (64.3%) were reported after the first two months of use, while 35.7% of local reactions were reported after 4.5 months of use. Of the 16 women with infections who did not have the implants immediately removed, 8 eventually required or requested removal, indicating that the ICCR recommendation for immediate removal in case of infection appears appropriate. An awareness of the frequency of insertion site complications, distribution of the time of onset post-insertion and potential sequelae of complications will aid clinicians in better client counseling and complication management.

Adult↗
PubMed1989

Case-fatality rates for tubal sterilization in U.S. hospitals, 1979 to 1980.

To update a 1977 to 1978 case-fatality estimate for tubal sterilization in U.S. hospitals, we reviewed the medical records of women reported by the Commission on Professional and Hospital Activities to have died after tubal sterilization procedures in 1979 or 1980. We project that the most reasonable case-fatality rate estimate is slightly greater than 9 per 100,000 sterilizations if all deaths associated with the procedure are considered. Rate estimates that assume minimum and maximum numbers of all associated deaths in our sample are approximately 6 per 100,000 and 10 per 100,000 sterilizations, respectively. However, when only deaths that can be attributed to sterilization per se are considered, the most reasonable case-fatality rate is estimated at between 1 and 2 per 100,000 procedures, a lower rate than previously reported. Rate estimates that assume minimum and maximum numbers of attributable deaths in our sample are approximately 1 per 100,000 and 5 per 100,000 sterilizations, respectively. These results further indicate that death attributable to tubal sterilization is rare.

Female↗
PubMed1989

Bleeding patterns and acceptability among Norplant users in two Asian countries.

Changes in menstrual bleeding patterns are the most frequent reason for discontinuing NORPLANT during the first year of use. Although NORPLANT is used by more women in Asia than in any other region, the changes that occur among these women are not well documented. In pre-introductory clinical trials of NORPLANT in the Philippines and Sri Lanka, 175 women were enrolled with greater than 95% continuing the method after one year. Daily menstrual bleeding calendars were kept by 94% of subjects for nine months and by 66% for one year. In contrast to findings in previous studies which showed that approximately 60% of NORPLANT users had bleeding disruptions in the first year of use, almost all of these women experienced bleeding disruptions. In a one-year study of menstrual pattern changes, increased bleeding was found to occur with the same frequency as reduced bleeding. However, the changes experienced by the Asian women tended to be decreases, rather than increases, in menstrual bleeding.

Adult↗
PubMed1989

A comparative evaluation of the safety and contraceptive effectiveness of 65 mg and 100 mg of 90-day norethindrone (NET) injectable microspheres: a multicenter study.

The first of a second generation of slow-release injectable contraceptives is the norethindrone (NET) microspheres with a 90-day duration of action. It was evaluated at 65-mg and 100-mg doses for safety and contraceptive effectiveness in two randomized, single-blind trials among 131 women: 94 women for 12 months and 37 women for 6 months. The 6-month trial included additional evaluations of ovarian function and serum NET values. In the 6-month trial, no indication of ovulation was detected in the 100-mg dose group, while 3 of the 19 women in the 65-mg group showed signs of ovulation (progesterone greater than 3 ng/ml). No pregnancies were reported in the 100-mg group and one pregnancy in the 65-mg group resulted in a life-table pregnancy rate for that dose of 2.6 per 100 woman-years (95% confidence interval, 0 to 7.5). Days of vaginal bleeding were analyzed for 30 days before treatment and in 90-day reference periods after treatment. The mean number of vaginal bleeding and spotting days increased initially after the first injection in both dose groups, but decreased to below baseline in both dose groups after 6 months. The two doses appear comparable in clinical safety, side effects, vaginal bleeding patterns, and laboratory measures. With the preliminary estimate of efficacy, the 65-mg dose would be the minimally effective dose for the NET 90-day injectable contraceptive.

Adult↗
PubMed1988

A comparison of two cause-of-death classification systems for deaths among women of reproductive age in Menoufia, Egypt.

Mortality data ascertained from sources other than a death registration system can validate the accuracy of the system, but this information is rarely obtained. Data on 1979 deaths among reproductive age women were collected in the 1981-1983 Reproductive Age Mortality Survey (RAMOS) in the governorate of Menoufia, Egypt, and compared with data on these deaths as recorded by the Egyptian death registration system. Although the distribution of the causes of death were similar, there were substantial differences between classification systems for deaths due to particular causes. Over half of the deaths classified differently by the systems were those assigned to circulatory disease on the death certificate. In contrast, there was a high rate of agreement between systems in the classification of trauma deaths. About half (52.4%) of cancer deaths had the same site-specific cancer diagnosis assigned by RAMOS. The percentage of deaths assigned to maternal causes was three times higher in RAMOS (19.2%) than on death certificates (6.1%). Reported mortality rates for this often-preventable cause of death have been substantially underestimated in national death registration systems. Such underreporting masks the need for additional prenatal care and maternal health programmes.

Adolescent↗
PubMed1987

Complications of vasectomies in the United States.

Physicians in the United States were surveyed in 1983 to gather information concerning the number of vasectomies they performed in 1982 as well as their use of anesthesia and complications of those vasectomies. Most urologists performed vasectomies, whereas family physicians and general surgeons were less likely to do so. As expected, most physicians used local anesthesia, occasionally in combination with a sedative; however, 22 percent of physicians reported using general anesthesia for at least some vasectomies. Complication rates were in the ranges reported by previous case series. Physicians who performed between one and ten vasectomies in 1982 had higher rates of hematoma and hospitalization for treatment of a complication than physicians who performed more vasectomies. Maintenance of surgical skills appears to be important in preventing complications of this usually low-risk procedure.

Anesthesia, General↗
PubMed1986

Human papillomavirus and cervical neoplasia: epidemiological considerations.

Recent clinical research using new diagnostic and laboratory techniques indicates that human papillomavirus (HPV) infection may play a key role in the development of cervical neoplasia. Cervical HPV infection is found in 1-3% of routine Papanicolaou smears, and preliminary data suggest that women with cervical HPV infection have about a tenfold greater risk of developing cervical intraepithelial neoplasia (CIN) compared with those with no HPV infection. This paper discusses how epidemiological studies can reduce misclassification of cervical HPV infection and CIN through selective use of research advances in cytologic, histologic and colposcopic techniques. These studies can also assess whether certain potential cocarcinogens interact synergistically with HPV. Since an estimated 2-10% of women with cervical HPV lesions develop associated CIN within a year, it appears feasible to conduct prospective studies of the risk of malignant transformation of cervical HPV lesions.

Biopsy↗
PubMed1985

Regret after decision to have a tubal sterilization.

To determine characteristics associated with regretting sterilization that can be determined preoperatively, we analyzed data from the Collaborative Review of Sterilization (CREST), a multicenter, prospective, observational study. Of 5022 women, 2.0% regretted having had a tubal sterilization at 1 year after the procedure and 2.7% did so after 2 years. Using a multivariate analysis to identify risk factors for regret, we found that almost all characteristics were more closely associated with regret at 1 year than at 2 years postoperatively. Of the characteristics we examined that could be objectively determined preoperatively, we considered only age less than 30 years and (for whites) a concurrent cesarean section to be risk factors for regret at 2 years after sterilization. However, in absolute terms, less than 10% of women with both those risk factors regretted having the procedure.

Adolescent↗
PubMed1985

Contraceptive use before tubal sterilization.

A woman's decision to undergo tubal sterilization may be affected by her experience with temporary contraception. To examine this issue we analyzed data from the Collaborative Review of Sterilization, a multicenter, prospective study of the health effects of sterilization operations on women aged 15-44 years. Data on contraceptive use by a comparison group of nonsterilized women were drawn from a random, population-based sample of women aged 20-44 years who were controls in a large study of cancer and steroid hormone use. Sterilized women reported ever using a higher average number of contraceptive methods than did nonsterilized women. As compared with nonsterilized women, a higher percentage of sterilized women reported ever using contraceptives (99% versus 91%), especially two types, barrier and rhythm or withdrawal. Prior to selecting sterilization as a permanent contraceptive method, the sterilized women had more extensive experience with temporary contraceptives, particularly the less effective ones, than did the comparable nonsterilized women.

Adult↗
PubMed1985

Luteal phase pregnancy and tubal sterilization.

The effectiveness of several measures that may reduce the risk of luteal phase pregnancies after interval tubal sterilization was analyzed. Using data from the Collaborative Review of Sterilization on 5495 women, 18 luteal phase pregnancies were identified. Women who underwent sterilization after their estimated date of ovulation had a low risk of having a luteal phase pregnancy if they used oral contraceptives or an intrauterine device in the month before sterilization. Of the 18 luteal phase pregnancies, 14 (78%) occurred among the 16.8% of the women who were sterilized after their estimated date of ovulation and who had used barrier, rhythm, or withdrawal methods of contraception in the month before sterilization. The use of concurrent dilatation and curettage in these women at increased risk of luteal phase pregnancy did not lower their risk to that of women who were sterilized before their estimated date of ovulation.

Adult↗