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NCT Number: NCT06529952

Comparative Study Between Hormonal and Hysteroscopic Management of Cesarean Scar Defect

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.

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Key information

Conditions

Cesarean Scar Defect

Age range

25 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

El shatby hospital Alexandria university, Alexandria, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hysteroscopic surgery by resection and endocoagulation

Procedure

resection of lower edge, resection of upper edge and endocoagulation

hysteroscopic surgery by endocoagulation only

Procedure

hysteroscopic endocoagulation to the base of the niche by roller ball

hormonal treatment

Drug

using 3rd generation contraceptive pills

Primary outcomes

  1. presence or absence of intermenstrual spotting,

    Time frame: 6 months

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

  2. presence or absence of postcoital bleeding

    Time frame: 6 months

    improvement of postcoital bleeding in all groups after 6 months

  3. presence or absence of pelvic tenderness or dyspareunia

    Time frame: 6 months

    improvement of postcoital bleeding in all groups after 6 months

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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