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49 Medical Vs. Surgical Methods for Second Trimester Abortion

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49 Medical Vs. Surgical Methods for Second Trimester Abortion 49 Medical vs. surgical methods for second trimester abortion Lohr et al. (2008) compared dilatation and evacuation (D&E) to medical methods of abortion in the second trimester (≥ 13 weeks), specifically intra-amniotic installation of prostaglandin F2α and mifepristone and misoprostol. The outcomes considered were complications, side-effects, completion of abortion and patient satisfaction. Although this review is from 2008, it is considered up-to-date as a recent litera- ture review revealed no additional studies which would meet inclusion criteria. Only two trials were included, one addressing each comparison. Gestational age ranged from 13 to 20 weeks among included trials. The trial quality is rated as low, given only one trial is included in each comparison and for the D&E versus mifepristone and misoprostol comparison the trial was very small (n=18) and had a primary outcome (feasibility of randomising US women to one of two methods of abor- tion) differing from the outcomes assessed in the review. The review found that the incidence of combined minor and major complications was lower with D&E compared with installation of prostaglandin F2α (Table 33). Fewer women experienced adverse events with D&E compared with mifepristone combined with misoprostol, although there were no differences in efficacy between the two groups. These results should be interpreted with caution given they are based on one small trial (n=18). The authors conclude that D&E is superior to installation of prostaglandin F2α and that the limited available evidence also favours D&E over mifepristone and misoprostol for decreased rates of adverse events. The GRADE Tables 33 to 34 provide a summary of the comparisons presented in the review. 50 Author(s): P. Whyte Date: 2009-12-22 Question: Should prostaglandins alone vs. vacuum aspiration be used for first trimester abortion?1,2 Bibliography: Say L et al. Medical versus surgical methods for first trimester termination of pregnancy. Cochrane Database of Systematic Reviews, 2005, (1):CD003037 updated 2010. Table 30: Quality assessment Summary of findings No of patients Effect Quality No of stud- Other consid- vacuum aspi- Relative ies Design Limitations Inconsistency Indirectness Imprecision erations prostaglandin ration (95% CI) Absolute Importance abortion not completed with intended method 43 more per 1000 randomized no serious no serious 16/238 RR 2.67 (1.06 ⊕⊕OO 23 serious4 serious5 none 6/234 (2.6%) (from 2 more to 147 CRITICAL trials inconsistency indirectness (6.7%) to 6.75) LOW more) ongoing pregnancy 13 fewer per 1000 randomized no serious no serious RR 0.55 (0.16 ⊕⊕OO 23 serious4 serious5 none 4/238 (1.7%) 7/234 (3%) (from 25 fewer to 25 CRITICAL trials inconsistency indirectness to 1.84) LOW more) pelvic infection 22 more per 1000 randomized no serious no serious no serious RR 2.17 (0.64 ⊕⊕⊕O 16 serious5 none 8/203 (3.9%) 4/216 (1.9%) (from 7 fewer to 117 CRITICAL trials limitations inconsistency indirectness to 7.33) MODERATE more) duration of bleeding (Better indicated by lower values) randomized no serious no serious no serious no serious MD 5.20 higher (4.98 ⊕⊕⊕O IMPOR- 16 none 203 216 - trials limitations inconsistency indirectness imprecision to 5.42 higher) HIGH TANT 1 Prostaglandins were two vaginal suppositories containing either 50 or 60mg of 9-methylene-PGE2 administered at 6-h intervals at home or administered in hospital or intramuscular injections of 0.5 mg PGE2methyl sulfonyla- mide three times at 3-h intervals. 2 Gestational age ranged from 7 to 13 weeks among included trials. 3 Rosen 1984; WHO 1987 4 Allocation concealment is unclear in Rosen (1984). 5 Wide confidence interval. 6 WHO 1987 51 Author(s): P. Whyte Date: 2009-12-22 Question: Should mifepristone 600mg alone vs. vacuum aspiration be used for first trimester abortion?1 Bibliography: Say L et al. Medical versus surgical methods for first trimester termination of pregnancy. Cochrane Database of Systematic Reviews, 2005, (1):CD003037 updated 2010. Table 31: Quality as- sessment Summary of findings No of patients Effect Quality Other consid- mifepristone vacuum aspi- Relative No of studies Design Limitations Inconsistency Indirectness Imprecision erations 600mg alone ration (95% CI) Absolute Importance abortion not completed with intended method 210 more per randomized no serious no serious no serious RR 3.63 (0.66 1000 (from ⊕⊕⊕O 12 serious3 none 6/25 (24%) 2/25 (8%) CRITICAL trials limitations inconsistency indirectness to 20.11) 27 fewer to MODERATE 1529 more) pelvic infection 104 fewer per randomized no serious no serious no serious RR 0.13 (0.01 1000 (from ⊕⊕⊕O 12 serious3 none 0/25 (0%) 3/25 (12%) CRITICAL trials limitations inconsistency indirectness to 2.58) 119 fewer to MODERATE 190 more) uterine perforation 27 fewer per randomized no serious no serious no serious RR 0.32 (0.01 1000 (from ⊕⊕⊕O 12 serious3 none 0/25 (0%) 1/25 (4%) CRITICAL trials limitations inconsistency indirectness to 8.25) 40 fewer to MODERATE 290 more) 1 Gestational age ranged from 7 to 13 weeks among included trials. 2 Legarth 1991 3 Total number of events < 300. 52 Author(s): P. Whyte Date: 2009-12-22 Question: Should mifepristone + prostaglandin vs. vacuum aspiration be used for first trimester abortion?1 Bibliography: Say L et al. Medical versus surgical methods for first trimester termination of pregnancy. Cochrane Database of Systematic Reviews, 2005, (1):CD003037 updated 2010. Table 32: Quality as- sessment Summary of findings No of patients Effect Quality mifepristone Other consid- and prosta- vacuum aspi- Relative No of studies Design Limitations Inconsistency Indirectness Imprecision erations glandin ration (95% CI) Absolute Importance abortion not completed with intended method 40 more per randomized no serious no serious no serious RR 2.12 (0.37 1000 (from ⊕⊕⊕O 12 serious3 none 4/55 (7.3%) 2/56 (3.6%) CRITICAL trials limitations inconsistency indirectness to 12.06) 23 fewer to MODERATE 395 more) blood loss (Better indicated by lower values) MD 1.90 randomized no serious no serious no serious higher (0.05 ⊕⊕⊕O 14 serious5 none 99 96 - IMPORTANT trials limitations inconsistency indirectness to 3.75 MODERATE higher) duration of bleeding (Better indicated by lower values) MD 2.94 randomized no serious no serious no serious ⊕⊕⊕O 26 serious7 none 217 207 - higher (2.1 to IMPORTANT trials inconsistency indirectness imprecision MODERATE 3.78 higher) pain resulting from procedure 3396 more per 1000 randomized no serious no serious 182/186 163/180 RR 4.75 (1.56 ⊕⊕OO 18 serious7 serious 3 none (from 507 IMPORTANT trials inconsistency indirectness ( 97.8%) (90.6%) to 14.39) LOW more to 12125 more) 53 Quality as- sessment Summary of findings No of patients Effect Quality mifepristone Other consid- and prosta- vacuum aspi- Relative No of studies Design Limitations Inconsistency Indirectness Imprecision erations glandin ration (95% CI) Absolute Importance vomiting 795 more per RR 10.54 randomized no serious no serious 91/186 15/180 1000 (from ⊕⊕OO 18 serious7 serious 3 none (5.77 to IMPORTANT trials inconsistency indirectness (48.9%) (8.3%) 397 more to LOW 19.23) 1519 more) diarrhoea 661 more per RR 15.87 randomized no serious no serious 79/186 1000 (from ⊕⊕OO 18 serious7 serious 3 none 8/180 (4.4%) (7.38 to IMPORTANT trials inconsistency indirectness (42.5%) 284 more to LOW 34.15) 1473 more) 1 Gestational age ranged from 7 to 13 weeks among included trials. 2 Rorbye 2004 (600 mg mifepristone and 1 mg gemeprost) 3 Wide confidence interval. 4 Henshaw 1994. Oral mifepristone 600mg followed by gemeprost 1mg 48 hours later. 5 Based on one trial with a small sample size. 6 Henshaw 1994; Ashok 2002 7 The Ashok (2002) trial only randomized those patients who did not have a preference for either surgical or medical methods. 8 Ashok 2002. Oral mifepristone 200mg followed by vaginal misoprostol 800 mcg 36-48 h later, if no products passed, a further two doses of misoprostol (400mcg) were given either orally or vaginally at 3 hourly intervals. 54 Author(s): P. Whyte Date: 2009-12-07 Question: Should dilatation and evacuation vs. intraamniotic PG F2-alpha be used for second trimester abortion?1 Bibliography: Lohr PA, Hayes JL, Gemzell-Danielsson K. Surgical versus medical methods for second trimester induced abortion. Cochrane Database of Systematic Reviews, 2008, (1):CD006714. Table 33: Quality as- sessment Summary of findings No of patients Effect Quality Other consid- dilatation and intraamniotic Relative No of studies Design Limitations Inconsistency Indirectness Imprecision erations evacuation PG F2-alpha (95% CI) Absolute Importance febrile morbidity 71 fewer per randomized no serious no serious no serious OR 0.20 (0.02 1000 (from ⊕⊕OO 12 very serious3 none 1/50 (2%) 4/44 (9.1%) CRITICAL trials limitations inconsistency indirectness to 1.9) 89 fewer to LOW 69 more) requirement for additional curettage 3 fewer per randomized no serious no serious no serious OR 0.88 (0.05 1000 (from ⊕⊕OO 12 very serious3 none 1/50 (2%) 1/44 (2.3%) CRITICAL trials limitations inconsistency indirectness to 14.46) 22 fewer to LOW 229 more) haemorrhage (requiring transfusion) 37 fewer per randomized no serious no serious no serious OR 0.17 (0.01 1000 (from ⊕⊕OO 12 very serious3 none 0/50 (0%) 2/44 (4.5%) CRITICAL trials limitations inconsistency indirectness to 3.6) 45 fewer to LOW 101 more) haemorrhage (not requiring transfusion) 105 fewer per randomized no serious no serious no serious OR 0.07 (0 to 1000 (from ⊕⊕OO 12 very serious3 none 0/50 (0%) 5/44 (11.4%) CRITICAL
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