Maryam Khooshideh1, Nasim Yarmohammadi1, Ali Shahriari2, Mahdi Sheikh3. 1. a Department of Obstetrics and Gynecology , Arash Women's Hospital, Tehran University of Medical Sciences , Tehran , Iran. 2. b Department of Anesthesiology , Roozbeh Hospital, Tehran University of Medical Sciences , Tehran , Iran , and. 3. c Maternal, Fetal and Neonatal Research Center, Vali-Asr Hospital, Tehran University of Medical Sciences , Tehran , Iran.
Abstract
OBJECTIVE: Comparing the efficacy of low-dose sublingual misoprostol plus laminaria to medium-dose sublingual misoprostol alone for cervical dilation before surgical management of late first trimester missed abortions. METHODS: Randomized, controlled trial evaluated 70 women with missed abortion, admitted for surgical termination of pregnancy. The patients were randomly assigned to receive 200 μg sublingual misoprostol with cervical laminaria (intervention group) or 400 μg sublingual misoprostol without laminaria (control group), four hours before surgical process. The study is registered at www.irct.ir (IRCT2014070711020N4). RESULTS: More patients in the intervention group achieved the desired cervical dilation (≥Hegar7) before surgical process than the control group (91.4% versus 17.1%, p < 0.001). Patients in the intervention group experienced less pain during the waiting period (mean Visual Analog Scale scores: 30.8 ± 3.7 versus 43.7 ± 5.9, p < 0.001), and had higher satisfaction level (highly satisfied: 97.1% versus 77.1%, p = 0.02). Four patients in the intervention group and none in the control group had spontaneous expulsion of pregnancy products (p = 0.11). CONCLUSIONS: Compared to medium-dose sublingual misoprostol alone, using a combination of cervical laminaria plus low-dose sublingual misoprostol before surgical process is associated with significantly more effective and rapid cervical dilation, lower requirement for mechanical dilation, lower abdominal pain and discomfort during the waiting period and higher patients' satisfaction.
RCT Entities:
OBJECTIVE: Comparing the efficacy of low-dose sublingual misoprostol plus laminaria to medium-dose sublingual misoprostol alone for cervical dilation before surgical management of late first trimester missed abortions. METHODS: Randomized, controlled trial evaluated 70 women with missed abortion, admitted for surgical termination of pregnancy. The patients were randomly assigned to receive 200 μg sublingual misoprostol with cervical laminaria (intervention group) or 400 μg sublingual misoprostol without laminaria (control group), four hours before surgical process. The study is registered at www.irct.ir (IRCT2014070711020N4). RESULTS: More patients in the intervention group achieved the desired cervical dilation (≥Hegar7) before surgical process than the control group (91.4% versus 17.1%, p < 0.001). Patients in the intervention group experienced less pain during the waiting period (mean Visual Analog Scale scores: 30.8 ± 3.7 versus 43.7 ± 5.9, p < 0.001), and had higher satisfaction level (highly satisfied: 97.1% versus 77.1%, p = 0.02). Four patients in the intervention group and none in the control group had spontaneous expulsion of pregnancy products (p = 0.11). CONCLUSIONS: Compared to medium-dose sublingual misoprostol alone, using a combination of cervical laminaria plus low-dose sublingual misoprostol before surgical process is associated with significantly more effective and rapid cervical dilation, lower requirement for mechanical dilation, lower abdominal pain and discomfort during the waiting period and higher patients' satisfaction.
Authors: Jay Ghosh; Argyro Papadopoulou; Adam J Devall; Hannah C Jeffery; Leanne E Beeson; Vivian Do; Malcolm J Price; Aurelio Tobias; Özge Tunçalp; Antonella Lavelanet; Ahmet Metin Gülmezoglu; Arri Coomarasamy; Ioannis D Gallos Journal: Cochrane Database Syst Rev Date: 2021-06-01