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.

Client-centered approach to develop a seating clinic satisfaction questionnaire: a qualitative study.

OBJECTIVE: The purpose of this study was to develop a program evaluation tool through a client-centered approach. Client satisfaction questionnaires previously developed for service recipients of a pediatric seating clinic have reflected the professionals' views on what should be asked. METHOD: Seven parents and caregivers of recent service recipients of the seating clinic participated in tape-recorded semistructured interviews. They were asked their views on the seating clinic, how the service could be improved, and the quality of the seat received through the clinic. RESULTS: Data were coded into nine themes related to the process and the product. Using these themes and the vocabulary used by the participants, we developed a satisfaction questionnaire. The validity of the questionnaire was evaluated by requesting feedback on clarity, content, and design from all participants and from a panel of five health professionals. CONCLUSION: A client-centered approach can be used to develop a client satisfaction tool that reflects the needs of the users. Future work will involve testing the tool in the clinical setting.

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.

Treatment of acute pelvic inflammatory disease in the ambulatory setting: trial of cefoxitin and doxycycline versus ampicillin-sulbactam.

Ampicillin-sulbactam (750 mg) given orally twice daily for 10 days was evaluated for the treatment of acute pelvic inflammatory disease (PID) in an ambulatory setting in Nairobi, Kenya. The first 26 women received ampicillin-sulbactam in an open-label fashion, and the remaining 75 women were randomly selected to receive either ampicillin-sulbactam (n = 38) or cefoxitin (2 g) intramuscularly and probenecid (1 g) orally, followed by doxycycline (100 mg) orally twice daily for 10 days (n = 37). Women were enrolled in a sexually transmitted disease clinic and were followed for clinical and microbiologic responses at 1 to 2 weeks and 4 to 6 weeks posttreatment. Women had a later follow-up visit to note interim pregnancy or underwent hysterosalpingography for fertility outcome assessment. The short-term clinical response rates were 70% for ampicillin-sulbactam and 72% for cefoxitin-doxycycline (P = 0.47). Among Chlamydia trachomatis-infected women treated with ampicillin-sulbactam, three had microbiologic relapse. The post-PID tubal obstruction rates were similar in the two groups: 18% for ampicillin-sulbactam and 33% for cefoxitin-doxycycline (P = 0.31). Neither regimen was highly effective as a therapy for acute PID. These data strongly argue that primary prevention must be the goal for a reduction of PID morbidity and show that improved therapy for the treatment of PID in the ambulatory setting is needed.

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.

Fallopian tube obstruction as a sequela to Chlamydia trachomatis infection.

The association of tubal infertility and ectopic pregnancy with Chlamydia trachomatis infection was investigated using a case-control study design. Although culture methods failed to document active chlamydial infection in the majority of cases, serology revealed a significant association of Chlamydia trachomatis antibody with tubal infertility and ectopic pregnancy. Thirteen of 18 (72%) women with tubal factor infertility and 18 of 32 (56%) women with ectopic pregnancy had antibodies to Chlamydia trachomatis as compared to 11 of 49 (22%) normal pregnant controls. Interestingly, only 7 of 18 (39%) infertile women and 5 of 36 (14%) women with ectopic pregnancy recalled a history of pelvic inflammatory disease. These results suggest that chlamydia-associated salpingitis, whether clinically evident or subclinical, is a major contributor to diseases of tubal dysfunction.