NCT06529952

Comparative Study Between Hormonal and Hysteroscopic Management of Cesarean Scar Defect

Comparative Study Between Hysteroscopic Management of Cesarean Scar Defect and Hormonal Treatment. A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: Female
• Age: 25 Years – 42 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
PROCEDURE	hysteroscopic surgery by resection and endocoagulation	resection of lower edge, resection of upper edge and endocoagulation
PROCEDURE	hysteroscopic surgery by endocoagulation only	hysteroscopic endocoagulation to the base of the niche by roller ball
DRUG	hormonal treatment	using 3rd generation contraceptive pills

Timeline

• Start date: 2022-02-10
• Primary completion: 2022-12-01
• Completion: 2023-02-20
• First posted: 2024-07-31
• Last updated: 2024-07-31

Locations

2 sites across 1 country: Egypt