Autry 1999.
Methods | Randomisation using a random number tables. Allocation concealment was accomplished in sequentially numbered opaque sealed envelopes made available at the time of enrolment in the study. Intention‐to‐treat analysis. Sinai Samaritan Medical Center and the Medical College of Wisconsin; no information on study duration. |
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Participants | 21 women diagnosed with a non‐viable first trimester intrauterine pregnancy up to 49 days gestation. Evidence of non‐viability included 1 of the following findings on TVS: 1) mean gestational sac diameter greater than 18 mm and no embryonic pole; 2) embryonic pole 5 mm to 10 mm without cardiac activity; 3) intrauterine gestational sac with abnormal hCG titres. Others entry criteria: 1) 18 years of age or greater; 2) closed cervix on digital exam; 3) no known intolerance or allergy to misoprostol or MTX; 4) haemoglobin of 9 g/dL or greater; 5) platelet count of 100,000/µL or greater; 6) no history of blood clotting disorders; 7) no active liver or renal disease; 8) ability and willingness to comply with visit schedule; 9) hCG less than 40,000 IU/L; and 10) easy access to a telephone and transportation. | |
Interventions | Combined group (n = 12): IM MTX 50 mg/m2 body surface area (day 1) followed 2 days later (day 3) by vaginal misoprostol 800 mcg (by vaginal placement of 4 200 mcg tablets of misoprostol). If the gestational sac was present vaginal misoprostol was repeated. Misoprostol only group (n = 9): 4 200 mcg tablets placed in the vagina on day 1. The remainder of the follow‐up was similar to that for combined group. | |
Outcomes | Successful complete abortion: MTX plus misoprostol 12/12 vs misoprostol only 8/9. No blood transfusion or antibiotics. Positive urine pregnancy test at the initial follow‐up appointment: 2/9 vs 7/7. Pain relief: 4/12 vs 4/9. | |
Funding | No information on funding. | |
Declarations of interest | No information on conflicts of interest. | |
Notes | Wisconsin, Milwaukee, USA. All women received: 1) prescription for 10 tablets acetaminophen with codeine (300 mg/30 mg) and 8 tablets of ibuprofen (600 mg); 2) instruction sheet including phone number to contact physician 24 hours/day; and a diary sheet to record symptoms, side effects, and pain medication use. Data about side effects (headache, nausea and emesis) and women's satisfaction reported as no separate data. Authors conclude that both treatments are effective regimens for the complete evacuation of non‐viable early first trimester pregnancy, and represent a reasonable alternative for women wishing to avoid surgery. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed using a random number table for each centre". |
Allocation concealment (selection bias) | Low risk | Quote: "Allocation concealment was accomplished in sequentially numbered opaque sealed envelopes made available at the time of enrolment in the study". Comment: adequate type of allocation concealment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: according to the results section outcomes were measured for all 21 included patients, no signs of loss to follow‐up or incomplete data. |
Selective reporting (reporting bias) | Low risk | Comment: no signs of selective reporting; all outcomes mentioned in the methods section were presented in the results section. |
Other bias | Low risk | No other source of bias could be detected |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: no information on blinding of participants and personnel, probably not done. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: no information on blinding of outcome assessor, probably not done. |