M.Asherman uterine synechiae or intrauterine adhesions
Conditions
Interventions
Consented patients undergoing hysteroscopic adhesiolysis will be randomly
allocated to receive secondary prevention of M. Asherman with exogene hormonal
support to stimulate the endometrium post ope
Sponsors
Spaarne Ziekenhuis
Eligibility
Age
18 Years to 99 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 to the uterine cavity due to pregnancy related surgical procedure with the presence of intrauterine adhesions with a previous history of normal menstrual bloodflow.
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 estrogen and or gestagen -Patients who use hormonal suppletion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We aim to answer the following primary question: Does exogenous hormone administration (oral administration of estrogen and gestagen) starting immediately after successful hysteroscopic adhesiolysis, in patients with M. Asherman reduces or prevents the incidence and severity (ESGE score/classification) of intra-uterine re-adhesions better then the endogen production of hormones. Presence and extent of adhesions will be evaluated by hysteroscopy 2 months after the initial procedure, using the ESGE classification (Appendix 3.) | — |
Secondary
| Measure | Time frame |
|---|---|
| We aim to answer the following secondary questions: 1. Does secondary prevention of M. Asherman with hormonal support post operative adhesiolysis restore the normal menstrual bloodflow on shorter (2months) and longterm (6 and 9months) assessed with a *Pictorial Blood Loss Assement* (PBAC) (Appendix II). 2. Does secondary prevention of M. Asherman with hormonal support post operative adhesiolysis increase the pregnancy rate. This the hazzard 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. 3. The number of performed 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. 4. Complication related to postoperative estrogen and gestagen administration or any side-effec | — |
Countries
Netherlands
Outcome results
None listed