Aspects of miscarriage management - Anna Fernlund
Disputationer - 29 Okt - 29 Okt 2021
13.00 Medicinska fakulteten. Institutionen för kliniska vetenskaper, Malmö
Handledare: docent Povilas Sladkevicius, Lunds universitet
Ordförande: professor Stefan Hansson, Lunds universitet
Opponent Professor Christina Bergh, Göteborg
Meeting ID: 649 3115 5912 Password: 543059
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To compare treatment with vaginal misoprostol and expectant management in women with early miscarriage reporting vaginal bleeding. Treatment efficiency, complications, side effects, psychological reactions, patient satisfaction and subsequent fertility were compared. Variables were explored with respect to their ability to predict treatment success. Methods: Randomized controlled trial. Women with embryonic or anembryonic miscarriage and vaginal bleeding were randomized (1:1) to expectant management or treatment with vaginal misoprostol, 800μg single dose. Scheduled follow up until complete miscarriage (no gestational sac in uterus and maximum anteroposterior diameter of intracavitary contents < 15 mm) was achieved, at most 31 days. Analysis was by intention to treat. Main outcome measure: rate of complete miscarriage without D&E ≤ 10days. Predefined secondary outcomes: complications, side-effects, rate of complete miscarriage within 17, 24, and 31 days after randomization, levels of anxiety, depressive symptoms, grief and satisfaction with treatment from randomization until 14 months after complete miscarriage and reproductive outcome at 14 months after complete miscarriage. Multivariable regression analysis of predefined variables in relation to their ability to predict treatment success in. Results: 94 women were randomized to misoprostol and 90 women to expectant management. More women in the misoprostol group than in the expectant group achieved complete miscarriage within 10 days: 62/94 (66.0%) vs 39/90 (43.3%) (risk difference (RD)=22.6%; 95% CI, 7.5–36.5%). The cumulative rate of complete miscarriage was higher in the misoprostol group at all time points - 17, 24 and 31days. At 31 days, complete miscarriage was achieved by 81/94 (86.2%) of women treated with misoprostol vs 55/90 (61.1%) of the women in the expectantly managed group (RD=25.1%; 95% CI, 11.6–37.5%). 11% (10/94) of women in the misoprostol group underwent D&E vs 34% (31/90) in the expectantly managed group (RD = - 23.8; 95% CI, -35.8 to -11.1). Treatment success after expectant management was more common in embryonic than in anmebryonic miscarriages: complete miscarriage within 10 days 53.8% (28/52) versus 33.0% (11/33) (P=0.06). No variable predicted success after misoprostol treatment. Variables independently associated with treatment success after expectant management were gestational age according to LMP, mean gestational sac diameter and CRL (or type of miscarriage). The AUCs of the models ranged from 0.71 to 0.77. Psychometric scores and patient satisfaction were similar in the two treatment groups at all assessment points. Symptom scores for anxiety and depression were significantly higher at inclusion than after treatment and remained low. At inclusion, 37% (34/92) of the women treated with misoprostol and 41% (35/86) of the women managed expectantly had STAI-state scores indicating "high levels of anxiety" and 10% (9/91) and 9% (8/86) had symptoms indicating moderate/severe depression. Grief reactions were mild and patients’ satisfaction with treatment was high in both groups. The reproductive outcome at 14 months after complete miscarriage did not differ between the groups; 75% of the women (67/89 and 62/83) had achieved at least one clinical pregnancy. Sixty-three percent (56/89) of the women in the misoprostol group and 55% (46/83) of those in the expectantly managed group delivered a live baby after a pregnancy conceived within 14 months after the index miscarriage (MD=7.5%; 95% CI, -7.9 to 22.4). Conclusions: Misoprostol treatment is more effective than expectant management for treatment of embryonic or anembryonic miscarriage in women with vaginal bleeding. Both methods are safe. Spontaneous resolution is significantly more likely in embryonic miscarriage than in anembryonic miscarriage. In terms of treatment satisfaction, psychological effects and subsequent fertility the treatments are equivalent and women’s’ preferences should guide treatment decisions.