The aim of this study was to compare expectant management, misoprostol applied vaginally and surgical evacuation in women with incomplete spontaneous abortion. The three gynecologic departments in Herlev, Gentofte and Glostrup, Copenhagen County participated in this prospective crossover study with alternating treatments every 4 months during 1 year. The entry criteria to the study were: fresh bleeding; and positive urine human chorionic gonadotrophine (hCG) or plasma-hCG > 30 IU/l; and a trans-vaginal ultrasound (US) demonstrating retained products of conception with an anterior–posterior diameter of 15–50 mm; and crown rump length (CRL) < 50 mm with no cardiac activity if a fetus was visible. The exclusion criteria were: age below 18 years, suspicion of ectopic pregnancy, allergy or contraindications against misoprostol, sign of infection, heavy bleeding demanding acute evacuation or women not speaking Danish. The three treatment regimens were: Expectant management (EM). Medical treatment with misoprostol 0.4 mg applied vaginally (MT) and 4 hr of observation. Surgical evacuation under general anesthesia (SE). P-progesterone and p-hCG were measured at day 1 and p-hCG again at days 8 and 14. All women were offered diclofenac 100 mg rectally for pain relief at day 1. A US examination was conducted at day 8. If the US demonstrated an anterior–posterior diameter > 15 mm or a gestational sac was visible, a repeat US was conducted at day 14. If at day 14 the US was unchanged or the anterior–posterior diameter was > 15 mm, SE or (in case of primary evacuation) re-evacuation was done. The participants were asked to return by mail a questionnaire covering treatment-related issues after 21 days. The study was approved by the Scientific Ethical Committee of Copenhagen County (KA 99114s). Test of significance was calculated by the χ2-test. Length of bleeding was tested also with the non-parametric Wilcoxon test. Level of significance was set at 5%. During the 1-year study period, 224 women were admitted with a spontaneous abortion. Of these, 124 fulfiled the entry criteria, 78 patients (63%) accepted inclusion. EM was successful in 14 (82%) of 17 women, MT in 28 (90%) of 31 women, and SE in 29 (97%) of 30 women. Two women (4%) in the EM + MT groups were treated with antibiotics due to endometritis, whereas no women were treated for postoperative infection in the SE group. Questionnaires were returned by 65 (83%) of the 78 women. The length of bleeding in the three groups were: EM, 6.5 days; MT, 7.6 days; and SE, 3.2 days (EM/SE: p < 0.05 and MT/SE < 0.01). Number of days with analgesic need: EM, 1.8 days; MT, 2.1 days; and SE 0.4 days (NS). The proportion of women recommending the specific regimens were: EM, 62%; MT, 67%; and SE; 84% (NS) The groups were too small to explore the predictive value of p-hCG or p-progesterone for secondary surgical evacuation. Table I summarizes the results of six previous studies (1–5 ) and this study. Women treated with misoprostol may have a higher expulsion rate (90%) when compared with EM (82%) ( 3 ), We administrated misoprostol vaginally, whereas Nielsen et al. gave tablets orally ( 3 ). Furthermore, a previous study demonstrated fewer side-effects when misoprostol is given vaginally as compared with oral administration ( 6 ). We therefore recommend misoprostol to be given vaginally. Expectant management is successful in most patients with incomplete spontaneous abortion with a mid-line echo of 15–50 mm, but implies a few days more bleeding than surgical intervention. Misoprostol, preferably given vaginally, may increase the rate of complete expulsion.
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Grønlund et al. (2002) studied this question.
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