|- candidate number||10483|
|- NTR Number||NTR3120|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-okt-2011|
|- Secondary IDs||2011/256 METc VUmc|
|- Public Title||Het voorkomen van littekenvorming in de baarmoeder bij vrouwen die een curettage ondergaan vanwege een miskraam. (Evaluatie van anti-verklevingsmiddel).|
|- Scientific Title||Post Abortion Prevention of Adhesions: Evaluation of hyaluronic acid, hyalobarier gel endo.|
|- ACRONYM||PAPA- study|
|- hypothesis||In the present proposal we aim to study whether the intrauterine application of hyaloronic acid (Hyalobarrier ® Gel Endo) immediately after curettage, in patients with a recurrent curettage reduces the incidence and severity (ESGE score/classification) of intra-uterine adhesions.|
|- Healt Condition(s) or Problem(s) studied||Intra-uterine adhesions, Miscarriage, Curretage|
|- Inclusion criteria||Consented patients, who had at least one previous suction or abrasive (blunt or sharp) curettage for a miscarriage in the history, visiting the outpatient clinic with a miscarriage and planned for curettage, will be included in the study. The ultrasound is a key in the diagnosis of miscarriage; at least one recent ultrasound examination (made within 7 days before randomisation) is required for inclusion. The maximum gestational age at inclusion is 14 weeks.|
|- Exclusion criteria||1. Patients with a suspected mola pregnancy;|
2. Patients with a previous hysteroscopic surgery (endometrial ablation, removal of fibroids or surgical correction of congenital uterine anomalies);
3. Patients with contra-indications for one of the procedures at the time of randomisation;
4. Patients who do not master the Dutch or English language;
5. Patients who are younger than 18 years of age or mentally incompetent;
6. Patients with severe signs of infection (sepsis).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-nov-2011|
|- planned closingdate||1-jun-2013|
|- Target number of participants||150|
|- Interventions||Patients will be randomised and allocated to curettage with adhesion prevention (hyaloronic) group or curettage alone (control) group. Hyaloronic acid will be applied intrauterine once, immediately after curettage. A hysteroscopy is planned 8-12 weeks after the initial operation for identification of the adhesions and their extent in all patients.|
|- Primary outcome||The primary outcome measure is number of patients with intra-uterine adhesions during the follow-up hysteroscopy.|
|- Secondary outcome||1. Severity of intra-uterine adhedsions (IUAs);|
2. Time to conceive during one year;
3. Number and time to clinical pregnancy during one year;
4. Number and time to ongoing pregnancy during one year;
5. Number of miscarriages during the first year after curettage.
|- Timepoints||01-11-2011: Start recruiting patients;|
01-06-2013: Finishing study.
|- Trial web site||www.papastudie.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. A.B. Hooker|
|- CONTACT for SCIENTIFIC QUERIES||Drs. A.B. Hooker|
|- Sponsor/Initiator ||Sint Lucas Andreas Ziekenhuis|
(Source(s) of Monetary or Material Support)
|Stichting Wetenschappelijk Onderzoek Gynaecologenmaatschap Amsterdam West, SWOGA.|
|- Brief summary||Women with a miscarriage undergoing a recurrent curettage have an increased risk for adhesions formation. Adhesion formation is related with menstrual disturbances, fertility disorders and if pregnancy occurs it may be complicated. Prevention of adhesion formation is essential because of the possible serious implications. Application of hyaluronic acid has shown to prevent adhesion formation in the uterine cavity.
The hysteroscopic control offers the possibility to assess the presence of adhesions and the option to perform immediate adhesiolysis. Both are independent of the study arm and may therefore be beneficial to every patient included in the study.
Applications of hyaluronic acid has shown to be a safe procedure; no potential risk has been reported since it’s introduction. Potential risks of curettage are bleeding, perforation of the uterus wall, infection and induction of intra-uterine adhesions.
Additional, patients are asked to fill in questionnaires (approximately 15 questions) 3, 6 months and one year after the procedure.
|- Main changes (audit trail)|
|- RECORD||27-okt-2011 - 7-nov-2011|