Randomised controlled trial comparing the efficacy of same-day administration of mifepristone and misoprostol for termination of pregnancy with the standard 36 to 48 hour protocol.

OBJECTIVE: To determine the efficacy of oral mifepristone followed by vaginal misoprostol 6 hours later compared with the standard 36- to 48-hour regimen for medical termination of pregnancy. DESIGN: Single centre, two arm, parallel, open randomised controlled trial. SETTING: Medical termination service at a teaching hospital. SAMPLE: Four hundred and fifty women undergoing medical termination of pregnancy at up to 63 days of gestation. METHODS: Eligible women were randomised to receive mifepristone 200 mg orally followed by vaginal misoprostol 800 micrograms either 6 hours (n=225) or 36-48 hours (n=225) later. All participants were invited to attend for a follow-up pelvic ultrasound scan within 7 days following the misoprostol administration. For those women in whom products of conception remained at the follow-up ultrasound scan, expectant management ensued with weekly follow-up ultrasound scans until the termination was complete. They could elect to undergo an evacuation of uterus at any stage following the scan. Those women with a nonviable gestation sac at the follow-up scan were offered a further dose of vaginal misoprostol 800 micrograms or suction termination of pregnancy. Women with a continuing pregnancy were managed with surgical termination. MAIN OUTCOME MEASURE: Successful medical abortion defined as no requirement for medical or surgical intervention beyond the initial dose of misoprostol. RESULTS: One hundred and sixty-five women (79%) in the 6-hour group and 197 women (92%) in the 36- to 48-hour group had a successful termination at first follow-up ultrasound or presumed on the basis of other considerations (those not seen for ultrasound but deemed successful by negative pregnancy test, products passed on ward or long-term assessment of notes). Twenty-two women (10%) in the 6-hour regimen required up to three further ultrasound scans after 7 days following the mifepristone administration in order to ensure that the termination process was complete. None of these women required a suction evacuation of uterus. In the 36- to 48-hour regimen, ten (5%) women had up to two further ultrasound scans to confirm a complete termination without the need for a surgical evacuation of uterus. Therefore, the overall successful termination rate in the 6-hour regimen was 89% (187/210) compared with 96% (207/215) in the 36- to 48-hour regimen (relative risk=0.92, 95% CI 0.84-0.98). Repeat administration of misoprostol or surgical treatment was required in 23 women (11%) in the 6-hour group and 8 women (4%) in the 36- to 48-hour group. A viable pregnancy was found in five women (2%) in the 6-hour group and in three women (1%) in the 36- to 48-hour group. CONCLUSIONS: Oral mifepristone 200 mg followed by vaginal misoprostol 800 micrograms after 6 hours is not as effective at achieving a complete abortion compared with the 36- to 48-hour protocol.

Chlamydia trachomatis-associated ectopic pregnancy: serologic and histologic correlates.

Fifty-five women with ectopic pregnancy and 24 undergoing tubal ligation with a segmental resection of the fallopian tube were evaluated for histopathology of the fallopian tube, Chlamydia trachomatis serum antibodies, antibodies to a chlamydial sarkosyl-soluble 57-kDa protein, and for isolation of C. trachomatis. Plasma cell infiltration in the fallopian tube submucosa was identified in 31 (65%) of 48 women with ectopic pregnancies and in 8 (33%) of 24 undergoing tubal ligation (P = .01; odds ratio [OR], 3.6; 95% confidence interval [CI], 1.3-10.3). Plasma cell infiltration was correlated with C. trachomatis seropositivity among women with ectopic pregnancy (P = .005; OR, 7.2; 95% CI, 1.7-31) and among women undergoing tubal ligation (P = .008). Of 21 C. trachomatis-seropositive women with ectopic pregnancies, 19 had antibodies to the 57-kDa antigen compared with 1 of 4 seropositive women having tubal ligation (P = .008). Immune responses to the 57-kDa antigen may be involved in the immunopathogenesis of C. trachomatis-associated ectopic pregnancy.

Etiology and outcome of acute pelvic inflammatory disease.

We studied 71 women with the clinical diagnosis of acute pelvic inflammatory disease (PID) by laparoscopy and comprehensive microbiology in order to define the major etiologic determinants of poor fertility prognosis after tubal infection. Fifty women were found to have acute PID. Of the 50 women, 23 were pregnancy seeking and had a subsequent evaluation to determine fertility outcome. Seven of 13 women with non-gonococcal infection had an adverse reproductive outcome, compared with none of 10 women with gonococcal infection (P = .007). Two groups of causes for adverse reproductive outcome were found. Of the seven infertile women, four had initial tubal abscess, and three had evidence of Chlamydia trachomatis infection. This study directly documents the poor fertility prognosis for women with tubal abscess and suggests that women with culture and/or serological evidence of chlamydial infection also have a poor fertility prognosis.