Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect

What Was Tested

This registered not phased trial tested Leuprolide.

It had two arms (groups): Vaginal Repair with Leuprorelin (experimental) and Vaginal Repair without Leuprorelin (no intervention).

CSD patients were treated with vaginal repair of CSD in combination with Leuprorelin . In the group of Vaginal Repair With Leuprorelin, the patients will get 3 times of Leuprorelin per 4 weeks perioperation. The detailed procedure of Vaginal Repair has been described in their previous study.

The detailed procedure of Vaginal Repair has been described in their previous study.

The registry classes the interventions as drug.

More on the Plan

Women with CSD complicated with adenomyosis will be enrolled in this study.

They all will receive vaginal excision and suture of CSD and will be required to undergo examinations at 6-months after surgery.

Interventioned group will be subcutaneous injected of Leuprorelin to postpone period after vaginal repair.

Who Took Part

The registry lists 94 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Clearly diagnosed with CSD complicated with adenomyosis. Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 10 days). The thickness of the remaining muscular layer of CSD was less than 3 mm. Normal range of blood sugar and insulin. No serious medical problems (important viscera function in the normal range).

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: indefinite diagnosis; malignant tumors; with severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-05-01 with completion listed for 2027-04-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: thickness of the remaining muscular layer (TRM) (mm) (time frame: 12 weeks after vaginal repair of CSD). Duration of menstruation (day) (time frame: 12 weeks after vaginal repair of CSD).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Leuprolide in 94 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.