Mohamed Rezk1, Elsayed Elshamy1,2, Abd-Elhamid Shaheen1, Mohamed Shawky3, Hala Marawan4. 1. Department of Obstetrics and Gynecology, Menoufia University, Menoufia, Egypt. 2. Department of Obstetrics and Gynecology, King Abdul-Aziz Airbase Hospital, Dhuhran, Saudi Arabia. 3. Department of Radiology, Menoufia University, Menoufia, Egypt. 4. Department of Public Health and Community Medicine, Faculty of Medicine, Menoufia University, Menoufia, Egypt.
Abstract
OBJECTIVE: To compare the effects of a levonorgestrel-releasing intrauterine system (LNG-IUS) and a copper intrauterine device (Cu-IUD) on menstrual changes and uterine artery Doppler indices. METHODS: A randomized clinical trial was conducted at Menoufia University Hospital, Egypt, between December 2016 and August 2017. 306 multiparous women desiring intrauterine contraception were randomly assigned to LNG-IUS (n=152) or Cu-IUD (n=154). Uterine artery pulsatility index (PI) and resistant index (RI) were measured before use, and 3 and 6 months after insertion, and associations with abnormal bleeding were evaluated. RESULTS:Irregular bleeding was initially reported by 31 (74%) of 42 women in the LNG-IUS group, and heavy menstrual bleeding by 53 (67%) of 79 women in the Cu-IUD group. Incidence of abnormal bleeding decreased over the 6-month study period. Uterine artery PI was significantly correlated with abnormal bleeding at a cutoff of 1.35 with area under the curve (AUC) 0.93, sensitivity 88%, and specificity 100%, whereas uterine artery RI was significantly correlated with abnormal bleeding at a cutoff of 0.62 with AUC 0.1, sensitivity 96%, and specificity 100%. CONCLUSION:LNG-IUS-related abnormal bleeding was associated with changes in uterine artery blood flow that were not evident among Cu-IUD users. Pan African Clinical Trials Registry: PACTR201701001900640.
RCT Entities:
OBJECTIVE: To compare the effects of a levonorgestrel-releasing intrauterine system (LNG-IUS) and a copper intrauterine device (Cu-IUD) on menstrual changes and uterine artery Doppler indices. METHODS: A randomized clinical trial was conducted at Menoufia University Hospital, Egypt, between December 2016 and August 2017. 306 multiparous women desiring intrauterine contraception were randomly assigned to LNG-IUS (n=152) or Cu-IUD (n=154). Uterine artery pulsatility index (PI) and resistant index (RI) were measured before use, and 3 and 6 months after insertion, and associations with abnormal bleeding were evaluated. RESULTS: Irregular bleeding was initially reported by 31 (74%) of 42 women in the LNG-IUS group, and heavy menstrual bleeding by 53 (67%) of 79 women in the Cu-IUD group. Incidence of abnormal bleeding decreased over the 6-month study period. Uterine artery PI was significantly correlated with abnormal bleeding at a cutoff of 1.35 with area under the curve (AUC) 0.93, sensitivity 88%, and specificity 100%, whereas uterine artery RI was significantly correlated with abnormal bleeding at a cutoff of 0.62 with AUC 0.1, sensitivity 96%, and specificity 100%. CONCLUSION: LNG-IUS-related abnormal bleeding was associated with changes in uterine artery blood flow that were not evident among Cu-IUD users. Pan African Clinical Trials Registry: PACTR201701001900640.