NO INCREASE IN POSTABORTAL COMPLICATIONS WITH HIGHER EFFICACY—A SAFETY ANALYSIS OF LOADING DOSE VAGINAL MISOPROSTOL FOR SECOND-TRIMESTER ABORTION: A RANDOMIZED CONTROLLED TRIAL
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Abstract
Objective: This study examines the safety of a higher-efficacy, loading-dose vaginal misoprostol regimen for second-trimester abortion, emphasizing postabortal complications compared with a standard non-loading regimen.
Methods: A prospective randomized controlled trial involved 60 women (18–40 years, 13–24 weeks gestation) given mifepristone 200 mg orally, then randomized to either a loading-dose vaginal misoprostol regimen (800 µg loading dose, then 400 µg every 3 hours; Group A) or a non-loading regimen (400 µg every 3 hours; Group B), both to a maximum of five doses. Data on efficacy, adverse drug reactions, and postabortal complications were systematically collected. The primary safety outcomes were rates of incomplete abortion, hemorrhage, infection, and uterine rupture. Secondary outcomes included rates of adverse drug reactions such as fever, nausea, and vomiting.
Results: Both groups achieved 100% complete abortion within 36 hours. No participants in either group experienced major postabortal complications (incomplete abortion, hemorrhage, infection, uterine rupture). Fever was more common in the loading-dose group (33.3% vs 10%, p=0.028). No significant difference in rates of nausea or vomiting between groups. No cases required blood transfusion or surgical intervention. The incidence of any postabortal complication was 0% in both groups.
Conclusion: Loading-dose vaginal misoprostol provides higher efficacy (shorter induction-abortion interval, reduced drug requirement) with no observed increase in postabortal complications compared to the non-loading regimen, supporting its safety for second-trimester abortion.
References
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Ishu Mehta
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
Drishti Rana
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