Nonsurgical Management of Cesarean Scar Niche Related Abnormal Uterine Bleeding

NCT05594186 | Completed

• 1 other identifier: SGHM-FEB2019-OBGYN
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intermenstrual Bleeding

Outcome Measures

Primary Outcomes (1)

• Improvement of post-menstrual spotting

  Improvement of post-menstrual 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.

  12 months

Study Arms (4)

Tranexamic acid

ACTIVE COMPARATOR

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.

Drug: Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system.

Combined oral contraceptive pill

ACTIVE COMPARATOR

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.

Drug: Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system.

Tranexamic acid plus Combined oral contraceptive pill

ACTIVE COMPARATOR

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.

Drug: Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system.

Levonorgestrel-releasing intrauterine system

ACTIVE COMPARATOR

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.

Drug: Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system.

Interventions

Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system. DRUG

Comparing three different nonsurgical management options for abnormal uterine bleeding caused by cesarean scar niche.

Combined oral contraceptive pill; Levonorgestrel-releasing intrauterine system; Tranexamic acid; Tranexamic acid plus Combined oral contraceptive pill

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Saudi German Hospital - Madinah: lead

Study Sites (1)

Saudi German Hospital

Al Madīnah, Madinah, 41311, Saudi Arabia

Location

MeSH Terms

Conditions

Metrorrhagia

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Islam Mohamed Magdi Ammar, M.D.

  Saudi German Hospital - Madinah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant and associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Study Start: March 1, 2019
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)