Nonsurgical Management of Cesarean Scar Niche Related Abnormal Uterine Bleeding
Intermenstrual Bleeding
About this trial
This is an interventional treatment trial for Intermenstrual Bleeding
Eligibility Criteria
Inclusion Criteria:
- The study included 158 patients aged between 20 and 40 years who had a history of at least one caesarean delivery and presented with abnormal uterine bleeding in the form of postmenstrual spotting defined as bloody or brownish discharge of more than two days after the end of menstruation, with the total duration of (menses and spotting) of more than 7 days, or intermenstrual bleeding that starts after the end of the menses, who were diagnosed to have a caesarean scar niche by saline infusion sonography. Cesarean scar niche was defined as an anechoic triangular indentation at the site of the previous cesarean scar with a depth of at least 2 mm. Saline infusion sonography was done, in which instillation of saline solution into the uterine cavity, enhanced the transvaginal ultrasonographic image by providing a sonolucent contrast medium to allow for better visualization and delineation of the defect. Evaluation was performed according to the 2019 modified Delphi procedure where the basic evaluation of CS niche included measurements of the length, depth and width of the defect, the residual myometrial thickness (RMT) and the adjacent myometrial thickness (AMT). All measurements were made in the sagittal plane except the width which was measured in the transverse plane. The 4.5 MHz endovaginal transducer was used.
Exclusion Criteria:
- Exclusion criteria were: pregnancy, desire for fertility within one year of enrolment in the study, any medical condition contraindicating the use of combined oral contraceptive pills, history of abnormal uterine bleeding dating before the last caesarean section, use of any hormonal treatment 3 months prior to enrolment, coagulopathy, and organic causes of bleeding like uterine fibroids, adenomyosis or endometrial hyperplasia.
Sites / Locations
- Saudi German Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Tranexamic acid
Combined oral contraceptive pill
Tranexamic acid plus Combined oral contraceptive pill
Levonorgestrel-releasing intrauterine system
Patients in group A, received Tranexamic acid 1300 mg (2 tablets of 650 mg) three times daily for 5 days starting from the first day of menses for 12 months.
Patients in group B, received combined oral contraceptive pill (OCP) once daily for 21 days (Desogestrel 150 micrograms/ Ethinylestradiol 30 micrograms, tablets), starting from the first day of menses, then to have a one-week pill free period to allow for a withdrawal bleed, and that was repeated for 12 cycles.
Patients in group C, received a combination of Tranexamic acid 1300 mg three times daily for 5 days, and a combined oral contraceptive pill once daily for 21 days (Desogestrel 150 micrograms/ Ethinylestradiol 30 micrograms, tablets), both starting from the first day of menses for 12 consecutive cycles.
Patients in group D, had the levonorgestrel-releasing intrauterine system inserted into the uterine cavity. The insertion was done by a skilled gynecologist as an outpatient procedure without anesthesia.