RANDOMIZED CONTROLLED TRIAL COMPARING EFFICACY BETWEEN A VAGINAL MISOPROSTOL LOADING AND NON-LOADING DOSE REGIMEN FOR SECOND-TRIMESTER PREGNANCY TERMINATION
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Keywords
Misoprostol, mifepristone, loading dose, early mid trimester abortion (13–20 weeks), induction abortion interval
Abstract
Objective: To compare the efficacy between a vaginal misoprostol loading and non-loading dose regimen for second trimester pregnancy termination.
Methods: A randomized controlled trial was conducted among women undergoing mid-trimester abortion MTA. At enrollment, 60 women were randomized (group A: loading dose [mifepristone 200 mg, then 48 h later 800 µg loading dose vaginal misoprostol followed by 400 μg vaginal misoprostol every 3 h for 5 doses] versus group B: non-loading dose [mifepristone 200mg, then 400 µg vaginal misoprostol every 3h for 5 doses ]. Demographic and clinical data were collected at enrollment and abortion.
Results: Women in group A had statistically significantly shorter Induction-abortion interval IAI ( 7.88h vs. 13.21h, for group A and group B, respectively; p < 0.001). All the women in group A had complete abortion within 12 hours, compared to 11 women (36.7%) in group B (p < 0.001). Median number of doses of vaginal misoprostol required in group A were 3 (IQR: 3–4) versus 5 (IQR: 4–5) in group B (p < 0.001). Fewer women required additional oxytocin for complete abortion (group A vs. group B; 1 vs. 4, respectively, p = 0.161). In our study, all women had complete abortion. There were no significant differences with respect to maternal complications.
Conclusions: Loading dose of vaginal misoprostol significantly shortens the IAI (p<0.001) in women undergoing mid-trimester abortion.
Trial Registration: Clinical Trial Registry of India www.ctri.nic.in CTRI/2023/09/057640 (date; 14-09-2023).
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Ishu Mehta
Department of Obstetrics and Gynecology, Dr. Rajendra Prasad Government Medical College, Tanda, Himachal Pradesh, India
Drishti Rana
Department of Obstetrics and Gynecology, Dr. Rajendra Prasad Government Medical College, Tanda, Himachal Pradesh, India
Ashish Kumar
Department of Obstetrics and Gynecology, Dr. Rajendra Prasad Government Medical College, Tanda, Himachal Pradesh, India
Anjali Soni
Department of Obstetrics and Gynecology , Dr. Radhakrishnan Government Medical College, Hamirpur, Himachal Pradesh, India
Mamta Mahajan
Department of Obstetrics and Gynecology, Dr. Rajendra Prasad Government Medical College, Tanda, Himachal Pradesh, India
Manmeet Saini
Department of Pediatrics, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India
Abhinav Gautam
Department of Pediatrics, Dr Rajendra Prasad Government Medical College, Tanda, Himachal Pradesh, India