Clinical trial: Comparison of the Therapeutic Effects of VR and VR + GnRHa in the Treatment of Cesarean Scar Diverticula (NCT02932761)

Eligibility criteria:
Inclusion Criteria:

          1. Patients are younger than 40.

          2. Clearly diagnosed with CSD.

          3. Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow
             (the duration of menstruation is more than 7 days).

          4. The thickness of the remaining muscular layer of CSD was less than 3 mm.

          5. The women are at least 20 years old with singleton pregnancies and had undergone a
             cesarean delivery after at least 37 weeks of gestation.

          6. The medicine conservative treatment is invalid.

          7. Refusing or use birth control pills contraindications.

          8. No serious medical problems (important viscera function in the normal range).

          9. No uterine fibroids, endometriosis, adenomyosis, and patients with ovarian cysts.

         10. No gynaecology or other malignant tumors.

         11. Sign the informed consent.

        Exclusion Criteria:

          1. Over the age of 40;

          2. Indefinite diagnosis.

          3. The absence of clinical manifestations of CSD.

          4. The presence of menstrual irregularities before cesarean delivery.

          5. Coagulation disorders.

          6. Malignant tumors.

          7. With severe medical problems (severe liver disease, kidney disease, respiratory
             diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of
             important organs).

          8. Known chronic inflammatory diseases, any other uterine diseases (such as uterine
             fibroids, endometriosis and adenomyosis), uterine surgery except cesarean section.

          9. Use of intrauterine devices.

         10. Unwilling to comply with the research plan.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? 0