Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06529952
Enrollment
78
Registered
2024-07-31
Start date
2022-02-10
Completion date
2023-02-20
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Scar Defect

Keywords

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

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

Interventions

PROCEDUREhysteroscopic surgery by resection and endocoagulation

resection of lower edge, resection of upper edge and endocoagulation

PROCEDUREhysteroscopic surgery by endocoagulation only

hysteroscopic endocoagulation to the base of the niche by roller ball

using 3rd generation contraceptive pills

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 42 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
presence or absence of intermenstrual spotting,6 monthsimprovement of intermenstrual spotting in group a and B from 1 st month , and improvment in all groups after 6 months
presence or absence of postcoital bleeding6 monthsimprovement of postcoital bleeding in all groups after 6 months
presence or absence of pelvic tenderness or dyspareunia6 monthsimprovement of postcoital bleeding in all groups after 6 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026