Rene Tendler1,2, Jacob Bornstein1,2, Mohamad Kais1, Irina Masri1, Marwan Odeh3,4. 1. Department of Obstetrics and Gynecology, Galilee Medical Center-Nahariya, POB 21, 22100, Nahariya, Israel. 2. Galilee Faculty of Medicine, Bar Ilan University, Safed, Israel. 3. Department of Obstetrics and Gynecology, Galilee Medical Center-Nahariya, POB 21, 22100, Nahariya, Israel. marwan20@bezeqint.net. 4. Galilee Faculty of Medicine, Bar Ilan University, Safed, Israel. marwan20@bezeqint.net.
Abstract
PURPOSE: To evaluate the successful medical termination of pregnancy comparing two regimens: misoprostol 2 or 48 h after mifepristone administration. DESIGN: Prospective randomized study. SETTING: Department of Obstetrics and Gynecology. SAMPLE: One hundred pregnant women admitted for medical termination of pregnancy were enrolled; no pregnancies were over 55 days gestational age. METHODS: All subjects were randomly assigned for misoprostol administration either 2 or 48 h after mifepristone. All participants underwent transvaginal ultrasound examination for uterine contents 48 h and 3 weeks after mifepristone. MAIN OUTCOME MEASURE: Procedure failure, defined as the presence of fetal heart activity, presence of a gestational sac, or a need for uterine curettage after misoprostol administration. RESULTS: Each group consisted of 50 women. Fetal heart activity was significantly more frequent after 48 h in the 2-h interval group (10/50) than in the 48-h interval group (0/50) (p = 0.002). Three weeks after misoprostol administration, fetal heart activity was present in 4/50 (8 %) in the 2-h interval group (p = 0.118) and none of the 48-h interval group. At 48 h residual tissue was present in 13/50 (26 %) and 5/50 (10 %) in the 2 and 48-h interval groups, respectively (p = 0.031); this was reduced to 12/50 (24 %) compared to 5/50 (10 %) in the two groups, respectively (p = 0.054) after 3 weeks. CONCLUSIONS: Successful medical termination of pregnancy can be achieved using misoprostol administration 2 h after mifepristone in 76 % of cases. However, this regimen is not recommended as it is significantly inferior to the traditional 48-h interval regimen.
RCT Entities:
PURPOSE: To evaluate the successful medical termination of pregnancy comparing two regimens: misoprostol 2 or 48 h after mifepristone administration. DESIGN: Prospective randomized study. SETTING: Department of Obstetrics and Gynecology. SAMPLE: One hundred pregnant women admitted for medical termination of pregnancy were enrolled; no pregnancies were over 55 days gestational age. METHODS: All subjects were randomly assigned for misoprostol administration either 2 or 48 h after mifepristone. All participants underwent transvaginal ultrasound examination for uterine contents 48 h and 3 weeks after mifepristone. MAIN OUTCOME MEASURE: Procedure failure, defined as the presence of fetal heart activity, presence of a gestational sac, or a need for uterine curettage after misoprostol administration. RESULTS: Each group consisted of 50 women. Fetal heart activity was significantly more frequent after 48 h in the 2-h interval group (10/50) than in the 48-h interval group (0/50) (p = 0.002). Three weeks after misoprostol administration, fetal heart activity was present in 4/50 (8 %) in the 2-h interval group (p = 0.118) and none of the 48-h interval group. At 48 h residual tissue was present in 13/50 (26 %) and 5/50 (10 %) in the 2 and 48-h interval groups, respectively (p = 0.031); this was reduced to 12/50 (24 %) compared to 5/50 (10 %) in the two groups, respectively (p = 0.054) after 3 weeks. CONCLUSIONS: Successful medical termination of pregnancy can be achieved using misoprostol administration 2 h after mifepristone in 76 % of cases. However, this regimen is not recommended as it is significantly inferior to the traditional 48-h interval regimen.
Entities:
Keywords:
Failed medical termination of pregnancy; Mifepristone; Misoprostol; Regimen; Termination pregnancy