Timing of onset of contraceptive effectiveness in Norplant implant users. Part I. Changes in cervical mucus.

OBJECTIVE: To provide scientific data regarding the changes in cervical mucus within the first hours to days after Norplant implant insertion and to estimate when the cervical mucus is hostile enough to suggest a contraceptive effect. DESIGN: Multicenter, clinical descriptive study. SETTING: Family planning clinics. PATIENT(S): Forty-two women who were between days 8 and 13 of their menstrual cycle and who had requested Norplant implants were admitted to the study. INTERVENTION(S): Cervical mucus and blood samples were obtained. MAIN OUTCOME MEASURE(S): Cervical mucus scores, sperm penetration distances, and serum levels of progesterone, estradiol, and levonorgestrel. RESULT(S): The median cervical mucus score observed at baseline was 6 ("fair"), indicating that the mucus was already somewhat hostile before insertion of the Norplant implants. The median scores declined to 5 at 12 and 24 hours and continued to decrease through day 7 to 2 ("poor"), a score that is judged as hostile to sperm penetration. Overall, 73% of all subjects had a poor cervical mucus score by 3 days after insertion; at 7 days after insertion, 90% exhibited poor mucus and none had a good score. There was a substantial drop in the overall median distance traveled by the vanguard sperm after 12 hours for each cervical mucus score grouping. The distance traveled decreased rapidly between 12 and 24 hours to < 0.5 cm in subjects with fair and poor mucus, and by day 3, 91% of the subjects exhibited poor sperm penetration. CONCLUSION(S): On the basis of our findings, deterioration of the quality of the cervical mucus and sperm penetration is evident by 24 hours after insertion, although not to a level that would suggest adequate protection until 72 hours after insertion. Therefore, we are confident in recommending that backup methods of contraception (e.g, condoms) need not be used for more than 3 days after insertion, even when the implants are inserted close to ovulation. These findings provide policy makers, clinic managers, and clinicians with important information about how they can improve client access to Norplant implants.

PIP: To provide clinicians with evidence as to when the cervical mucus is hostile enough in new Norplant implant acceptors to indicate a contraceptive effect, 42 women requesting Norplant from clinical sites in Santo Domingo, Dominican Republic, and Baltimore, Maryland (US), in 1994-95 were enrolled in a clinical descriptive study. At baseline, when all women were between days 8 and 13 of their menstrual cycle, the median cervical mucus score was 6 ("fair") out of a possible maximum of 12. This score declined to 5 at 12 and 24 hours and continued to decrease through day 7, when it reached 2--a level judged hostile to sperm penetration. Overall, 73% of women had a "poor" cervical mucus score by day 3 and 90% were in this category by day 7. There were substantial drops in the overall median distance travelled by the vanguard sperm and in the percentage of subjects demonstrating poor sperm penetration after 12 hours for each cervical mucus score grouping. 91% of women had poor sperm penetration by day 3 and 93% by day 7. These findings suggest that backup contraceptive protection for the entire cycle after Norplant insertion--a standard recommendation--is not necessary given the profound effect of levonorgestrel on cervical mucus shortly after insertion, even in the event of possible ovulation.

Depot medroxyprogesterone acetate pioneers. A retrospective study at a North Carolina Health Department.

This article examines the characteristics of the first group of depot medroxyprogesterone acetate (DMPA) acceptors after US Food and Drug Administration (FDA) approval of the method and evaluates their continuation rates and factors associated with discontinuation. This was a population based retrospective study based on 12 months of clinic data for 510 women who began using DMPA in 1993 at a large county health department. Cumulative 12 month life table rates were calculated for the entire group and were then stratified by selected characteristics. The 4, 8, and 12 month continuation rates were 67%, 46%, and 35%, respectively. More than half of these women discontinued because of bleeding and nonbleeding side effects (25% and 28%, respectively). Almost 20% of these women were considered discontinuers because they waited longer than 16 weeks to return for an injection. As measured in this study, continuation rates for this first group of DMPA acceptors were low. The next step is to determine if the characteristics and patterns of use of these "pioneer" acceptors are representative of more recent acceptors, and if lessons learned from this group will lead to higher continuation rates.

PIP: Depo-Provera was approved for general contraceptive use in the US in October 1992. This retrospective study examined the records of the first 510 women who initiated Depo-Provera use at a North Carolina county health department in 1993. The mean age of Depo-Provera users in this series was 23.5 years; 80% were unmarried. The mean number of living children was 1.3. At the time of injection, an appointment was set for a second injection 12 weeks later. Women were considered as continuers as long as they received an injection within 16 weeks of the last injection--the maximum duration of effectiveness. A total of 181 acceptors (36%) continued Depo-Provera use for 12 months, with an average interval between injections of 13 weeks. The 4-month and 8-month continuation rates were 67% and 46%, respectively. Of the 227 discontinuations, 64 were due to non-bleeding-related side effects such as weight gain, headache, and hair loss and 56 were because of bleeding problems. An additional 39 discontinuations were by default, i.e., acceptors waited more than 16 weeks for repeat injection and were refused. Another 102 women (20%) were lost to follow-up. If it is assumed that women lost to follow-up continued at the same rate as other women, the 12-month continuation rate rises. Discontinuation rates were significantly lower among only two sociodemographic groups: women covered by Medicaid for either all or none of the injections and women who reported bleeding side effects at their last injection. The provision of estrogen therapy to Depo-Provera users who experience irregular bleeding could increase compliance with this new method.

The diaphragm with and without spermicide. A randomized, comparative efficacy trial.

OBJECTIVE: To determine the relative contraceptive efficacy of a diaphragm used with spermicide as compared to one used without. STUDY DESIGN: Two hundred sixteen women entered the study between September 1985 and December 1990. Of these, 84 were randomly assigned to the diaphragm-only group and 80 to the diaphragm-with-spermicide group as their primary method of contraception. In addition, a spermicide-only group was planned originally to serve as a control group to assess the contribution to efficacy made by a spermicide alone. Thirty-nine women were randomly assigned to this group, and 13 selected themselves for it. All were followed for a maximum of 12 months. The primary outcome variable was accidental pregnancy. The statistical difference between the two diaphragm groups was analyzed. RESULTS: The 12-month "typical use" failure rates for the diaphragm-only group were 28.6 per 100 women and for the diaphragm-with-spermicide group, 21.2. The 12-month cumulative consistent-use failure rates were 19.3 per 100 women for the diaphragm-only group as compared to 12.3 per 100 women for users of a diaphragm with spermicide. CONCLUSION: Although the consistent use rates were not significantly different, this study had low statistical power and hence gives no support to the hypothesis that adjunctive spermicide use fails to improve the effectiveness of the diaphragm method, especially in view of the magnitude and direction of the difference observed. Unless a study with sufficient power proves that the use of a diaphragm alone is statistically as effective as use of a diaphragm with spermicide, use of a spermicide in conjunction with the diaphragm continues to be the appropriate clinical recommendation.