Skip to main content
. 2006 Jul 19;2006(3):CD002253. doi: 10.1002/14651858.CD002253.pub3

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 enrollment in the study. Intention to treat analysis.
Participants 21 women diagnosed with a non‐viable first trimester intrauterine pregnancy up to 49 days gestation. Evidence of non‐viability included one of the following findings on TVS: 1) mean gestational sac diameter greater than 18 mm and no embryonic pole; 2) embryonic pole 5‐10 mm without cardiac activity; 3) intrauterine gestational sac with abnormal hCG titers. 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) hemoglobin of 9 g/dl or greater; 5) platelet count of 100,000/mcl 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 two days later (day 3) by vaginal misoprostol 800 mcg (by vaginal placement of four 200 mcg‐tablets of misoprostol). If the gestational sac was present vaginal misoprostol was repeated. Misoprostol only group (n = 9): four 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.
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
Allocation concealment (selection bias) Low risk A ‐ Adequate