TePA-study (Tertiary Prevention of morbus Asherman-study);Evaluation of placement of hyaluronic acid (hyalobarier ® Gel Endo) and placement of a intrauterine device without cu or hormones to maintain separation of the cavity and mechanically to prevent spontaneous recurrence of adhesions.<br>
- Conditions
- Asherman10046828
- Registration Number
- NL-OMON43266
- Lead Sponsor
- Spaarne Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 110
Consented patients with M. Asherman who had a successful hysteroscopic adhesiolysis, defined as a restore of the normal uterine cavity, are eligible for inclusion. Patients with M. Asherman should be defined as patients with any diminishing of blood flow (secondary amenorrhoea or secondary hypomenorrhoe) after trauma, hypoxia or infection to the uterine cavity due to pregnancy related surgical procedure with the presence of intrauterine adhesions with a previous history of normal menstrual blood flow.
- Patients with a suspected M. Asherman due to tuberculosis or schitsosomiasis.
- Patients with an uncorrected anovulation, amenorrhoe or oligomenorrhoe previous to the M. Asherman syndrome
- Patients with suspected M. Asherman due to hysteroscopic surgery with the use of electrocoagulation (used in fibroid or polyp surgery)
- Patients with congenital uterine anomalies
- Patients with contraindications for a surgical adhesiolysis
- Patients who do not master the Dutch or English language.
- Patients who are younger than 18 years of age or mentally incompetent.
- Patients with contraindications for Cu_IUD gel(hyalobarier ® Gel Endo)
- Patients who use hormonal suppletion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Incidence and severity of spontaneous recurrence of adhesions at 8-10 week<br /><br>second look hysteroscopy </p><br>
- Secondary Outcome Measures
Name Time Method