Nonsurgical Management of Cesarean Scar Niche Related Abnormal Uterine Bleeding

• Status: Completed
• Trial end date: 2022-10-20
• Target enrollment: 0
• Participant gender: Female

Summary

A study of the effect of three different nonsurgical methods for management of abnormal uterine bleeding caused by cesarean scar niche. The study was conducted at the Obstetrics and Gynaecology department of the Saudi German Hospital in Madinah- Saudi Arabia, during the period between March 2019 to October 2022. The study protocol was in accordance with the Helsinki declaration 1964 and the later amendments. A prospective approval was granted by the human research ethics committee of the hospital and the study participants have signed an informed consent.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saudi German Hospital - Madinah
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Levonorgestrel; Tranexamic Acid

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.