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.

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. - TePA-study (Tertiary Prevention of morbus Asherman-study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43266

Enrollment

110

Registered

2017-06-23

Start date

2016-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Asherman

Interventions

The same hysteroscopic adhesion resection will be performed on all patients, and then they will be randomly allocated to two groups. Intervention Group: installation of gel immediately after surgery

Adhesiolysis

Asherman

hyaluronic acid

Hysteroscopy

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
Incidence and severity of spontaneous recurrence of adhesions at 8-10 week second look hysteroscopy	—

Secondary

Measure	Time frame
We aim to answer the following secondary questions which strategy of prevention of spontaneous recurrence : * restores the normal menstrual blood flow better on shorter (3months) and long-term (6months and 1 year) assessed with a Pictorial Blood Loss Assement (PBAC) (Appendix4). * Has the best the pregnancy rate. This the hazard ratio for any ongoing pregnancy (in those patients willingly to conceive) after one year follow-up. During a follow up of 1 year the number and time to conceive will be recorded. The clinical as well as the ongoing pregnancies (defined as intra-uterine heart activity at 12 weeks gestation) and the course of the pregnancies will be recorded. * Needs the highest number of re-interventions (hysteroscopic adhesiolysis in the OR or outpatient clinic or adhesiolysis without hysteroscopy (dilatation) in outpatient clinic setting) during one year per patient will be closely monitored and recorded * Has the highest complications related to gel or IUD or any side-effect, such as intra uterine infection and discomfort of the patient.	—

Measure

Time frame

We aim to answer the following secondary questions which strategy of prevention of spontaneous recurrence : * restores the normal menstrual blood flow better on shorter (3months) and long-term (6months and 1 year) assessed with a *Pictorial Blood Loss Assement* (PBAC) (Appendix4). * Has the best the pregnancy rate. This the hazard ratio for any ongoing pregnancy (in those patients willingly to conceive) after one year follow-up. During a follow up of 1 year the number and time to conceive will be recorded. The clinical as well as the ongoing pregnancies (defined as intra-uterine heart activity at 12 weeks gestation) and the course of the pregnancies will be recorded. * Needs the highest number of re-interventions (hysteroscopic adhesiolysis in the OR or outpatient clinic or adhesiolysis without hysteroscopy (dilatation) in outpatient clinic setting) during one year per patient will be closely monitored and recorded * Has the highest complications related to gel or IUD or any side-effect, such as intra uterine infection and discomfort of the patient.

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)