Barbados Low Dose Aspirin Study in Pregnancy (BLASP): a randomised trial for the prevention of pre-eclampsia and its complications.

OBJECTIVE: To determine whether prophylactic, low dose controlled-release aspirin improves outcome for pregnant women and their babies in Barbados. DESIGN: Randomised placebo-controlled trial. SETTING: The Queen Elizabeth Hospital, Barbados. POPULATION: All women attending antenatal clinics between 12 and 32 weeks of gestation were eligible, if without specific contraindications to aspirin and unlikely to deliver immediately. METHODS: Randomisation was computer-generated in the antenatal clinic; 1822 women were allocated to receive 75 mg controlled-release aspirin and 1825 matching placebo. MAIN OUTCOME MEASURES: Proteinuric pre-eclampsia, other pregnancy-induced hypertension, pregnancy duration, birthweight, stillbirths and neonatal deaths, major neonatal events. RESULTS: All but three women from each group were followed up successfully. Forty-four percent were primigravid, and 8% had previous obstetric complications. There were no significant differences between the allocated treatment groups in the incidence of proteinuric pre-eclampsia (40 [2.2%] of those allocated aspirin, compared with 46 [2.5%] allocated placebo), of preterm delivery (255 [14.0%] vs 270 [14.8%]), of birthweight < 1500 g (32 [1.7%] vs 33 [1.8%]) or of stillbirth and neonatal death (44 [2.4%] vs 38 [2.1%]). Aspirin was not associated with excess risk of maternal or fetal bleeding. CONCLUSIONS: The results of this study in Barbados do not support the routine use of low dose aspirin for prevention of pre-eclampsia or its complications, confirming results of previous large trials in other settings.

PIP: The effect of administration of a prophylactic dose of controlled-release aspirin on the prevention of pre-eclampsia was investigated in a randomized placebo-controlled trial conducted at the Queen Elizabeth Hospital in Barbados in 1992-94. All women attending hospital antenatal clinics between 12 and 32 weeks of gestation were eligible for the study; enrolled were 1822 cases allocated to receive 75 mg of aspirin per day and 1825 matched controls who received a placebo. Study participants represented about 60% of women who gave birth during the enrollment period. Aspirin administration was not associated with any excessive risk of infant or maternal bleeding. However, there were no significant differences between cases and controls in terms of the incidence of proteinuric pre-eclampsia (2.2% vs. 2.5%), preterm delivery (14.0% vs. 14.8%), birth weight under 1500 g (1.7% vs. 1.8%), or stillbirth and neonatal death (2.4% vs. 2.1%). These results were not affected by the time of pregnancy at which aspirin prophylaxis was initiated or parity. The Barbados findings are consistent with previous studies and fail to support the routine use of low-dose aspirin for the prevention of pre-eclampsia and its complications.

Genital tract infections in sexually active women in Barbados.

Ninety-eight women attending three different clinics were prospectively studied for the presence of genital tract infections, including Chlamydia trachomatis. Of these 98 women, 35 were presenting to a polyclinic with symptoms of genital tract infection, 55 were attending an antenatal clinic for their first visit, and 8 referred to a colposcopy clinic because of an abnormal Papanicolaou smear were included. Gonorrhoea was detected in one patient, syphilis in two, and Trichomonas vaginalis in six. Candida albicans and Chlamydia trachomatis were each detected in 18 patients, while the most common condition was bacterial vaginosis, detected in 35 patients. The prevalence of these infections was lowest in patients referred for colposcopy and highest in the women attending the antenatal clinic. Chlamydia trachomatis was the most common sexually-transmitted pathogen detected in this population. These data emphasise the need for an aggressive approach to the diagnosis and treatment of chlamydial infection in females.

Placental transfer of methylprednisolone following maternal intravenous administration.

Seven normal patients in labor at term were given 125 mg of methylprednisolone hemisuccinate intravenously shortly before delivery. Analysis of maternal and cord plasma samples indicated that both the hemisuccinate and free alcohol forms of the corticosteroid were transported in pharmacologic levels to the fetal compartment. Since methylprednisolone may have less of an infection-potentiating effect than other commonly used corticosteroids, use of it as a stimulator of fetal lung surfactant deserves further investigation.

Comparative study of high-dose chorionic gonadotropin on the human and rat corpus luteum and effect of gonadotropin-releasing hormone on human luteal function.

Human chorionic gonadotropin (hCG) was administered to pseudopregnant rats with 4-day-old corpora lutea and to normal women on days 16 to 18 following onset of menses. In the rat serum progesterone levels fell by 90% within 8 hours as did unoccupied luteal luteinizing hormone (LH) receptors following treatment with hCG (100 IU). Total receptor number for LH, however, remained unchanged until after 12 hours. In the woman 20,000 or 40,000 IU of hCG given on day 16 and day 18 of the cycle did not reduce serum progesterone or serum estradiol levels although the serum hCG level was similar to that achieved in the rat. In fact, serum progesterone levels rose and the cycle length was extended by hCG treatment in the human. Conversely, treatment of the woman with gonadotropin-releasing hormone (GnRH, 500 microgram on day 16 and on day 18) caused an initial rapid rise, then a fall in serum progesterone levels and the cycle length was shortened. It was concluded that the human corpus luteum may be resistant to densensitization by hCG but possibly not to LH. However, the possibility cannot be excluded that GnRH may compromise luteal function through mechanisms independent of effects on pituitary gonadotropin secretion or action.