A comparison of three daily coital diary designs and a phone-in regimen.

Barrier contraceptive trials and disease intervention studies often utilize coital diaries to measure sexual exposures: dates and frequency of intercourse, product use, additional or alternative contraceptive use, and menstrual bleeding. The validity of these self-reported data is a matter of debate, but if used, better diary designs are sought. We studied 3 different coital diaries, plus a phone-in regimen (none or weekly) in a 3 x 2 factorial design to compare participant ratings and promptness of recording. Our underlying presumption was that ease of and satisfaction with use, and promptness of data collection, are associated with greater accuracy. A self-completed questionnaire at the end of the study collected comparative retrospective data. Diary 1 captured information about a single day on one page and had three columns, for up to three possible acts of intercourse. Diary 2 had the same question format as the first diary, but contained 7 days per page. Diary 3 had 7 days on a page, but instead of a column for each act, participants enumerated the number of acts, the types of contraception used, and condom use details. Half of the women in each diary group phoned in their data weekly. Phone-in improved participants' satisfaction with the diary design as reflected by higher ratings of diary features. Phone-in did not improve recall of data at the end of the study for any of the diaries. There were no differences in the promptness of diary completion. Diaries 1 and 2 showed good concordance with recalled data, and participants expressed a preference for the layout of Diary 2. Women assigned to Diary 3 expressed dissatisfaction with the design and were worse at recalling data at the end of the study, probably due to the complexity of that diary design.

A comparative study of a progestin-only oral contraceptive versus non-hormonal methods in lactating women in Buenos Aires, Argentina.

A non-randomized comparative clinical trial of the progestin-only oral contraceptive (POC), Ovrette (75 mcg norgestrel) (Wyeth), versus non-hormonal methods was conducted at two clinics in Buenos Aires, Argentina. The trial was designed to assess the breast-feeding patterns of women choosing progestin-only oral contraception and non-hormonal methods of contraception, and to study the relationship between lactation and the clinical performance of a POC. Five-hundred women were allocated to either the progestin-only pill group (n = 250) or to the non-hormonal group (n = 250) and were followed up monthly for six months after admission. Measurements in mean infant weight, mean infant length, and mean head circumference were similar throughout the follow-up period. Non-hormonal users reported significantly more self-perceived decreases in milk production at the 5th and 6th month follow-up intervals. Acceptance and continued use of the pill were excellent, with only one woman discontinuing because of a pregnancy which was attributed to user failure. The principal side effect reported by women in both groups was intermenstrual bleeding.

PIP: A nonrandomized, comparative, clinical trial of the progestin only oral contraceptive (OC) Ovrette (75 mcg norgestrel) vs. nonhormonal methods was conducted at 2 clinics in Buenos Aires, Argentina. The trial was designed to assess breast-feeding patterns of women choosing progestin- only OCs and nonhormonal methods of contraception and to study the relationship between lactation and the clinical performance of the OC. 500 women were allocated to either the progestin-only pill group (n=250) or t o the nonhormonal group (n=250) and were followed monthly for 6 months after admission. Measurements in mean infant weight, mean infant length, and mean head circumference were similar throughout the follow- up period. Nonhormonal users reported significantly more self-perceived decreases in milk production at the 5th an 6th month follow-up intervals. Acceptance and continued use of the pill were excellent, with only 1 women discontinuing because of a pregnancy which was the result of user failure. The principal side effect reported by women in both groups was intermenstrual bleeding.