Comparative Study Between Hormonal and Hysteroscopic Management of Cesarean Scar Defect

NCT06529952 | Completed

• 1 other identifier: 0107228
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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.

Conditions

Cesarean Scar Defect

Keywords

cesarean scar defect; hormonal treatment; hysterscopic treatment; endocoagulation; hysteroscopic resection

Outcome Measures

Primary Outcomes (3)

• presence or absence of intermenstrual spotting,

  improvement of intermenstrual spotting in group a and B from 1 st month , and improvment in all groups after 6 months

  6 months

• presence or absence of postcoital bleeding

  improvement of postcoital bleeding in all groups after 6 months

  6 months

• presence or absence of pelvic tenderness or dyspareunia

  improvement of postcoital bleeding in all groups after 6 months

  6 months

Study Arms (3)

Hysteroscopic resection

EXPERIMENTAL

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.

Procedure: hysteroscopic surgery by resection and endocoagulation

hysteroscopic endocoagulation

EXPERIMENTAL

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.

Procedure: hysteroscopic surgery by endocoagulation only

hormonal treatment

EXPERIMENTAL

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

Drug: hormonal treatment

Interventions

hysteroscopic surgery by resection and endocoagulation PROCEDURE

resection of lower edge, resection of upper edge and endocoagulation

Hysteroscopic resection

hysteroscopic surgery by endocoagulation only PROCEDURE

hysteroscopic endocoagulation to the base of the niche by roller ball

hysteroscopic endocoagulation

hormonal treatment DRUG

using 3rd generation contraceptive pills

hormonal treatment

Eligibility Criteria

• Age: 25 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (2)

El shatby hospital Alexandria university

Alexandria, Egypt

Location

Tamer

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: the study include three groups group 1: hysterostopic resection of the upper and lower edges of the CSD then endocoagulation group2: hysteroscopic endocoagulation group3: hormonal treatment by 3rd generation contraceptive pills for 6 months

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: July 31, 2024
• Study Start: February 10, 2022
• Primary Completion: December 1, 2022
• Study Completion: February 20, 2023
• Last Updated: July 31, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)