Comparative Study Between Hormonal and Hysteroscopic Management of Cesarean Scar Defect

Not Applicable

Completed

• Conditions: Cesarean Scar Defect
• Interventions: Procedure: hysteroscopic surgery by endocoagulation only; Drug: hormonal treatment; Procedure: hysteroscopic surgery by resection and endocoagulation

• Registration Number: NCT06529952
• Lead Sponsor: Alexandria University

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

Study Timeline

• Study Start: 2022-02-10
• Status Verified: 2022-06
• Primary Completion: 2022-12-01
• Study Completion: 2023-02-20
• Study First Submitted: 2024-07-27
• Study First Submitted QC: 2024-07-27
• Last Update Submitted: 2024-07-27
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hysteroscopic endocoagulation	hysteroscopic surgery by endocoagulation only	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.
hormonal treatment	hormonal treatment	26 patients received hormonal treatment in the form of 3rd generation combined oral contraceptive pills in a cyclic manner for 6 months.
Hysteroscopic resection	hysteroscopic surgery by resection and endocoagulation	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.

Primary Outcome Measures

Name	Time	Method
presence or absence of intermenstrual spotting,	6 months	improvement of intermenstrual spotting in group a and B from 1 st month , and improvment in all groups after 6 months
presence or absence of pelvic tenderness or dyspareunia	6 months	improvement of postcoital bleeding in all groups after 6 months
presence or absence of postcoital bleeding	6 months	improvement of postcoital bleeding in all groups after 6 months

Trial Locations

Locations (2)

Tamer; 🇪🇬 Alexandria, Egypt

El shatby hospital Alexandria university; 🇪🇬 Alexandria, Egypt