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Asherman SyndromePhase 4ADABNCT04671914

Prevalence of Intrauterine Adhesions After D&C With or Without Antiadhesion Gel After Abortion in Second Trimester.

A Phase 4 study testing Hyaluronic Acid 20 MG/ML Injectable Solution and Dilation and curretage in people with Asherman Syndrome and Abortion Late, run by Institute for the Care of Mother and Child, Prague, Czech Republic at 3 sites in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Only patients who sign an informed consent will be included. Patients after a miscarriage in the 2nd trimester of pregnancy who need to perform an instrumental revision of the uterine cavity (RCUI, revisio cavi uteri instrumentalis) will be randomized into two groups. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Asherman Syndrome, Abortion Late
What is being tested?
Hyaluronic Acid 20 MG/ML Injectable Solution and Dilation and curretage
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
3 sitesCzechia
Study dates
28 Sep 2021to 1 Apr 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Adult (18 to 40 years) women with a wish for future pregnancy
  • abortion in the 2nd trimester of pregnancy (over 12 weeks of pregnancy) with instrumental revision of the uterine cavity (RCUI)
  • signed informed consent

Who cannot join

  • age below 18 years, age over 40 years
  • history of previous uterine surgery (myomectomy, resection of the intrauterine septum, disruption of intrauterine adhesions)
  • suspected molar pregnancy
  • signs of pelvic infection
  • disagreement with participation in the study

Trial locations and contacts

3 sites in 1 country.

Jiri Hanacek, MD, Ph.D. contact

+420604154736

jiri.hanacek@upmd.eu

Czechia3 sites, 3 recruiting

  • 1.Lf Uk, Vfn

    Prague, 12000

    Michal Mara, Prof, michal@drmara.cz

    Recruiting

  • Instiue for Care of Moher and Childe

    Prague, 14000

    Jiří Hanáček, MD, 604154736, jiri.hanacek@upmd.eu

    jiri.hanacek@upmd.eu

    Recruiting

  • FN Bulovka

    Prague, 14800

    Peter Koliba, MD, peter.koliba@gmail.com

    Recruiting

Other trials in Czechia

About this study

Official title: Prevalence of Intrauterine Adhesions After the Application of Hyaluronic Acid Gel After Dilatation and Curettage in Women With Spontaneous Abortion or Induction of Abortion From 12+0 Till 23+6 Week of Pregnancy.

Only patients who sign an informed consent will be included. Patients after a miscarriage in the 2nd trimester of pregnancy who need to perform an instrumental revision of the uterine cavity (RCUI, revisio cavi uteri instrumentalis) will be randomized into two groups. In the first group, RCUI will be performed according to current standards. In the second group, an anti-adhesive preparation with hyaluronic acid (Hyalobarrier gel Endo) will be applied to the uterine cavity at the end of the RCUI procedure. Eight to twelve weeks after the operation, the occurrence of adhesions will be evaluated by ultrasound examination and diagnostic hysteroscopy (if adhesions will be detected, they will be disrupted). The study will also include the completion of a questionnaire in terms of the frequency and strength of the menstrual cycle. The presence of adhesions will be assessed according to The American Fertility Society (AFS).

Read the detailed description

Methodology Only patients who sign informed consent will be included. Patients after a miscarriage in the 2nd trimester of pregnancy who need to perform an instrumental revision of the uterine cavity (RCUI, revisio cavi uteri instrumentalis) will be randomized into two groups. In the first group, RCUI will be performed according to current standards. In the second group, an anti-adhesive preparation with hyaluronic acid (Hyalobarrier gel Endo) will be applied to the uterine cavity at the end of the RCUI procedure. Eight to twelve weeks after the operation, the occurrence of adhesions will be evaluated by ultrasound examination and diagnostic hysteroscopy (if adhesions will be detected, they will be disrupted). The study will also include the completion of a questionnaire in terms of the frequency and strength of the menstrual cycle. The presence of adhesions will be assessed according to The American Fertility Society (AFS).

Expected number of enrolled subjects: a total of 200 patients, 100 in each branch Entry criteria: Adult (18 to 40 years old) women with a wish for future pregnancy, abortion in the 2nd trimester of pregnancy (over 12 weeks of pregnancy) with instrumental revision of the uterine cavity (RCUI), signed informed consent

Exclusion criteria: age below 18 years, age over 40 years, history of previous uterine surgery (myomectomy, resection of the intrauterine septum, disruption of intrauterine adhesions), suspicion of molar pregnancy, signs of pelvic infection, disagreement with participation in the study

Primary goals of the project:

  1. determination of the frequency of intrauterine adhesions in women who underwent instrumental revision of the uterine cavity (RCUI, revisio cavi uteri instrumentalis) after abortion in the 2nd trimester of pregnancy
  2. to determine whether the application of an antiadhesive agent with hyaluronic acid has an effect on the frequency of intrauterine adhesions after this procedure

A similar prospective randomized multicenter study investigating the relationship of intrauterine adhesions using an intrauterine gel with hyaluronic acid was published in 2017 by Hooker. Patients were enrolled in the study up to the 14th week of pregnancy. The incidence of intrauterine adhesions was statistically lower in the hyaluronic acid group compared to the no treatment group (13% vs. 30.6%, RR 0.43, 95% CI 0.22-0.83, p 0.013). However, this study investigated RCUI in the first trimester of pregnancy. Our study is to our knowledge the first with a focus on the second trimester RCUI.

Secondary goals of the project:

  1. number of pregnancies (pregnancy rate) in the period of 24 months after RCUI in both groups
  2. number of term pregnancies in the 24 months after RCUI in both groups
Being tested
Hyaluronic Acid 20 MG/ML Injectable Solution, Dilation and curretage
Keywords
Asherman Syndrome, Abortion Late, Hyaluronic acid gel, Hysteroscopy
Medical subject headings
Gynatresia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyaluronic Acid 20 MG/ML Injectable SolutionDrug

    Application of hyaluronic acid gel into uterine cavity after After abortion in II trimester we do D\&C

  • Dilation and curretageOther

    After abortion in II trimester we do D\&C.

Study groups in NCT04671914
Study groupRoleWhat they receive
Hyaluronic acid gel after D&CActive comparatorAfter abortion in the II trimester, we provide D\&C and after the procedure, we apply in uterine cavity Hyaluronic acid gel.
Receives: Drug: Hyaluronic Acid 20 MG/ML Injectable Solution; Other: Dilation and curretage
Only D&CActive comparatorAfter abortion, in the II trimester, we provide only D\&C.
Receives: Other: Dilation and curretage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of Intrauterine adhesions after D&C and intrauterine application of hyaluronic acid gell.

    To find out wheter the application of antiadhesive agent with hyaluronic acid has an effect on the frequency of intrauterine adhesions after this procedure.

    Measured: 3 month

  2. Prevalence of Intrauterine adhesions after D&C.

    Dermination of the frequency of intrauterine adhesions in women who underwent instrumental revision of the uterine cavity (RCUI, revisio cavi uteri instrumentalis) after abortion in the 2nd trimester of pregnancy

    Measured: 3 month

Secondary outcomes (2)

  1. Pregnancy rate

    Number of pregnancies (pregnancy rate) in the period of 24 months after RCUI in both groups

    Measured: 24 month

  2. Delivery rate

    Number of term deliveries in the 24 months after RCUI in both groups

    Measured: 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start28 Sep 2021
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion1 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter prospective controlled study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04671914
Sponsor's protocol ID
Intrauterine adhesions 2020
Acronym
ADAB
Status last verified
May 2024
First submitted
10 Dec 2020
Last updated
13 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang X, Chen C, Wang L, Chen D, Guang W, French J. Conception, early pregnancy loss, and time to clinical pregnancy: a population-based prospective study. Fertil Steril. 2003 Mar;79(3):577-84. doi: 10.1016/s0015-0282(02)04694-0.

    PubMed 12620443

  • Rai R, Regan L. Recurrent miscarriage. Lancet. 2006 Aug 12;368(9535):601-11. doi: 10.1016/S0140-6736(06)69204-0.

    PubMed 16905025

  • ASHERMAN JG. Amenorrhoea traumatica (atretica). J Obstet Gynaecol Br Emp. 1948 Feb;55(1):23-30. doi: 10.1111/j.1471-0528.1948.tb07045.x. No abstract available.

    PubMed 18902559

  • Hooker AB, de Leeuw R, van de Ven PM, Bakkum EA, Thurkow AL, Vogel NEA, van Vliet HAAM, Bongers MY, Emanuel MH, Verdonkschot AEM, Brolmann HAM, Huirne JAF. Prevalence of intrauterine adhesions after the application of hyaluronic acid gel after dilatation and curettage in women with at least one previous curettage: short-term outcomes of a multicenter, prospective randomized controlled trial. Fertil Steril. 2017 May;107(5):1223-1231.e3. doi: 10.1016/j.fertnstert.2017.02.113. Epub 2017 Apr 6.

    PubMed 28390688

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Hyaluronic Acid 20 MG/ML Injectable Solution and Dilation and curretage in people with Asherman Syndrome and Abortion Late, run by Institute for the Care of Mother and Child, Prague, Czech Republic at 3 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jiri Hanacek, MD, Ph.D. (+420604154736, jiri.hanacek@upmd.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of Intrauterine adhesions after D&C and intrauterine application of hyaluronic acid gell. (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04671914, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.

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