Nonsurgical Management of Cesarean Scar Niche Related Abnormal Uterine Bleeding
Condition: Intermenstrual Bleeding
MeSH terms: Uterine Hemorrhage; Metrorrhagia; Hemorrhage
Study type: Interventional

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.
    

Detailed description: 
      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. 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. 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 (Canon Xario 200G Ultrasound, Japan) was used.

      Using an Open Epi version 3.21 computer-based software, patients were divided into four
      groups (A, B, C and D). 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
      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, 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. The possible long- and short-term side effects of
      the different interventions were carefully discussed with all patients, and those who were
      willing to participate had signed the informed consent before participation. The primary
      outcome was the improvement of postmenstrual spotting as reported by the patients in their
      menstrual diary at each of the follow up visits (three, six, nine and twelve months) after
      enrolment in the study.

      The participants were asked to complete the menstrual diary card that was designed based on
      that used in the study of Johannes and colleagues in 1996. The illustrated symbols at the top
      of the card indicated the heaviness of menstrual bleeding (flooding, heavy, normal, light or
      spotting) and the names of the months were written on the left side of the card.
    

Intervention name(s): Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system.
Intervention type(s): Drug
Intervention description(s): Comparing three different nonsurgical management options for abnormal uterine bleeding caused by cesarean scar niche.
Intervention MeSH terms: Tranexamic Acid; Contraceptive Agents; Levonorgestrel; Contraceptives, Oral; Contraceptives, Oral, Combined
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment