OBJECTIVE: To compare the psychological impact, acceptability and clinical effectiveness of medical versus surgical termination of pregnancy (TOP) at 13-20 weeks of gestation. DESIGN: Randomised trial. SETTING: Large UK tertiary centre. SAMPLE: Women accepted for TOP at 13-20 weeks of gestation. METHODS: Medical TOP (MTOP) using mifepristone and misoprostol or surgical TOP (STOP) by vacuum aspiration at <15 weeks of gestation, and by dilatation and evacuation at 15 or more weeks of gestation. MAIN OUTCOME MEASURES: Distress 2 weeks after TOP, measured by the impact of events scale (IES), and acceptability, measured by the proportion of women who would opt for the same procedure again. RESULTS:One hundred and twenty two women were randomised: 60 to the MTOPgroup and 62 to the STOP group. Twelve women opted to continue their pregnancy. Follow-up rates were low (n=66/110; 60%). At 2 weeks post-procedure there was no difference in total IES score between groups. However, compared with women undergoing STOP, women undergoing MTOP had a higher score on the IES intrusion subscale (mean difference 6.6; 95% CI 1.4-11.8), and a higher score on the general health questionnaire (GHQ) (P=0.033). Women found STOP more acceptable: compared with MTOP, more women would opt for the same procedure again (100% versus 53%, P≤0.001), and fewer women found the experience to be worse than expected (0% versus 53%, P=0.001). Women who had MTOP experienced more bleeding (P=0.003), more pain on the day of the procedure (P=0.008), and more days of pain (P=0.020). Of the 107 women who declined to participate, 58 (67%) preferred a STOP. CONCLUSIONS: Randomised trials of women requesting midtrimester TOP are challenging. Women found STOP less painful and more acceptable than MTOP.
RCT Entities:
OBJECTIVE: To compare the psychological impact, acceptability and clinical effectiveness of medical versus surgical termination of pregnancy (TOP) at 13-20 weeks of gestation. DESIGN: Randomised trial. SETTING: Large UK tertiary centre. SAMPLE: Women accepted for TOP at 13-20 weeks of gestation. METHODS: Medical TOP (MTOP) using mifepristone and misoprostol or surgical TOP (STOP) by vacuum aspiration at <15 weeks of gestation, and by dilatation and evacuation at 15 or more weeks of gestation. MAIN OUTCOME MEASURES: Distress 2 weeks after TOP, measured by the impact of events scale (IES), and acceptability, measured by the proportion of women who would opt for the same procedure again. RESULTS: One hundred and twenty two women were randomised: 60 to the MTOP group and 62 to the STOP group. Twelve women opted to continue their pregnancy. Follow-up rates were low (n=66/110; 60%). At 2 weeks post-procedure there was no difference in total IES score between groups. However, compared with women undergoing STOP, women undergoing MTOP had a higher score on the IES intrusion subscale (mean difference 6.6; 95% CI 1.4-11.8), and a higher score on the general health questionnaire (GHQ) (P=0.033). Women found STOP more acceptable: compared with MTOP, more women would opt for the same procedure again (100% versus 53%, P≤0.001), and fewer women found the experience to be worse than expected (0% versus 53%, P=0.001). Women who had MTOP experienced more bleeding (P=0.003), more pain on the day of the procedure (P=0.008), and more days of pain (P=0.020). Of the 107 women who declined to participate, 58 (67%) preferred a STOP. CONCLUSIONS: Randomised trials of women requesting midtrimester TOP are challenging. Women found STOP less painful and more acceptable than MTOP.
Authors: Daniel Grossman; Deborah Constant; Naomi Lince; Marijke Alblas; Kelly Blanchard; Jane Harries Journal: BMC Health Serv Res Date: 2011-09-19 Impact factor: 2.655