Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529952
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-27
Brief Title:
Comparative Study Between Hormonal and Hysteroscopic Management of Cesarean Scar Defect
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Study Between Hysteroscopic Management of Cesarean Scar Defect and Hormonal Treatment A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 gelsaline 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
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 by111 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None