Comparative Study Between Hormonal and Hysteroscopic Management of Cesarean Scar Defect

NCT ID: NCT06529952

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2023-02-20

Brief Summary

Up to 70% of women who have had a previous caesarean section experience uterine niche, with 30% having symptoms. Prevalence rates vary between 24-70% using transvaginal ultrasonography and 56-84% using gel/saline instillation sonohysterography. Classification involves the ratio of myometrial thickness at the scar to adjacent myometrium, with severe deficiency defined by a ratio of ≤50%. Dehiscence is defined as at least 80% myometrial thinning.

The aim of this work was to compare between the effectiveness of two different techniques of hysteroscopic ablation of cesarean scar defect and hormonal treatment to improve abnormal uterine bleeding and pelvic pain localized in the suprapubic area associated with isthmocele.

Detailed Description

The study include 78 women diagnosed with abnormal uterine bleeding (AUB). All cases were subjected for complete history taking, complete general and gynaecological examination, vaginal ultrasonography (TVUS) to confirm niche and exclude other pathologies. The women were randomly divided by1:1:1 ratio into three equal groups using double blind method with closed envelopes

Group A: include 26 patients subjected to hysteroscopic surgery in the form of resection of lower edge, resection of upper edge and endocoagulation to fulgurate the visible dilated blood vessels or endometrial-like glands inside the base of the niche by using a roller ball resectoscope with monopolar electrical current and glycine as distension media.

Group B: include 26 patients subjected to hysteroscopic endocoagulation to the base of the niche by roller ball using monopolar electrical current and glycine as distension media.

Group C: include 26 patients received hormonal treatment in the form of 3rd generation combined oral contraceptive pills in a cyclic manner for 6 months.

Follow up was done after 1, 3, 6 months, by TVUS to exclude presence of symptoms of abnormal uterine bleeding (AUB) and to assess different outcome measures including presence or absence of intermenstrual spotting, presence or absence of postcoital bleeding, presence or absence of Pelvic tenderness or dyspareunia

Conditions

Cesarean Scar Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hysteroscopic resection

26 patients subjected to hysteroscopic surgery in the form of resection of lower edge, resection of upper edge and endocoagulation to fulgurate the visible dilated blood vessels or endometrial-like glands inside the base of the niche by using a roller ball resectoscope with monopolar electrical current and glycine as distension media.

Group Type: EXPERIMENTAL

hysteroscopic surgery by resection and endocoagulation

Intervention Type: PROCEDURE

resection of lower edge, resection of upper edge and endocoagulation

hysteroscopic endocoagulation

include 26 patients subjected to hysteroscopic endocoagulation to the base of the niche by roller ball using monopolar electrical current and glycine as distension media.

Group Type: EXPERIMENTAL

hysteroscopic surgery by endocoagulation only

Intervention Type: PROCEDURE

hysteroscopic endocoagulation to the base of the niche by roller ball

hormonal treatment

26 patients received hormonal treatment in the form of 3rd generation combined oral contraceptive pills in a cyclic manner for 6 months.

Group Type: EXPERIMENTAL

hormonal treatment

Intervention Type: DRUG

using 3rd generation contraceptive pills

Interventions

hysteroscopic surgery by resection and endocoagulation

resection of lower edge, resection of upper edge and endocoagulation

Intervention Type: PROCEDURE

hysteroscopic surgery by endocoagulation only

hysteroscopic endocoagulation to the base of the niche by roller ball

Intervention Type: PROCEDURE

hormonal treatment

using 3rd generation contraceptive pills

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• women with age ranging from 25 to 42 years,
• previous cesarean section,
• presence of a cesarean scar defect on ultrasound with a residual myo3metrium of > 1.5 mm.

Exclusion Criteria

• any contraindications of hysteroscopy as an active pelvic infection, active genital herpes,
• Contraindications to hormonal treatment as medical conditions like breast cancer, history of deep venous thrombosis, Previous arterial thrombosis, pulmonary embolism, active liver disease, use of rifampicin, familial hyperlipidemia, pregnancy,
• patient refusal
• Any Other causes of abnormal uterine bleeding as polyp, adenomyosis. leiomyoma, malignancy, coagulopathy. and ovulatory disorders.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

El shatby hospital Alexandria university

Alexandria, , Egypt

Tamer

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0107228

Identifier Type: -

Identifier Source: org_study_id