Uterine Synechiae After Scraping for Natural MiscarriagePhase 3HYFACONCT02248376
Hyaluronic Acid and Uterine Synechiae
A Phase 3 study testing Gel in people with Uterine Synechiae After Scraping for Natural Miscarriage, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary purpose of the study is to compare efficiency of a non-stick gel application after scraping surgery for natural miscarriage with no non-stick gel application after scraping surgery. Post-scraping uterine synechiae rate will be established at the diagnostical hysteroscopy 6-8 weeks after surgery. Read more about this study
- Who is it for?
- Ages 18 to 46 years, women only
- Conditions the study is for
- Uterine Synechiae After Scraping for Natural Miscarriage
- What is being tested?
- Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2014to 14 Sep 2018
- Phase
- Phase 3
- 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 46 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women patients aged between 18 and 46 years old
- Term ≥ 7 weeks amenorrhea and ≤ 14 weeks amenorrhea
- Blighted ovum or not completed miscarriage or haemorrhagic miscarriage or retention miscarriage
- Consent signature
- Social security coverage
- Women who wants to be pregnant
Who cannot join
- Infected miscarriage
- Uncertain diagnosis between miscarriage and extra-uterine pregnancy
- Hydatiform mole
- Uterine synechiae history
- Surgical zone infection
- Hyalobarrier® gel Endo hypersensitivity
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- Clotting disorder
- Unstable diabetes
- Maternal malignant diseases
- Psychiatric disorder
- Incapacity in understanding the consent form and the questionnaires
- Law protected adult person
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Lariboisière - Service de Gynécologie-Obstétrique
Paris, 75010
About this study
Official title: Non-stick Gel Applicated After Scraping Surgery for Natural Miscarriage and Uterine Synechiae Prevention
The primary purpose of the study is to compare efficiency of a non-stick gel application after scraping surgery for natural miscarriage with no non-stick gel application after scraping surgery.
Post-scraping uterine synechiae rate will be established at the diagnostical hysteroscopy 6-8 weeks after surgery.
Read the detailed description
Women patients coming for natural miscarriage will be compared according to whether a non-stick gel will be applicated or not after scraping surgery.
6-8 weeks after this surgery uterine synechiae rate will be established at a diagnostical hysteroscopy. Proofreading of this exam will be made by 2 experts at the end of the study without knowing the randomization arm.
Long-term follow-up of the patients will be performed to evaluate the effect of the non-stick gel application on post-surgical fertility at 6, 12, and 24 months after scraping surgery using questionnaire asked by post, mail or phone.
- Being tested
- Gel
- Keywords
- Uterine synechiae Scraping surgery Natural miscarriage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GelDrug
Patients aged of more than 18 years-old coming for a natural miscarriage who will have the stick gel application at the end of the scraping surgery.
| Study group | Role | What they receive |
|---|---|---|
| Gel + | Experimental | Patients aged of more than 18 years-old coming for a natural miscarriage who will have the stick gel application at the end of the scraping surgery. Receives: Drug: Gel |
| Gel - | No intervention | Patients aged of more than 18 years-old coming for a natural miscarriage who will not have the non-stick gel application at the end of the scraping surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of post-surgical uterine synechiae rate during a diagnostical hysteroscopy.
Diagnostical hysteroscopy performed 6-8 weeks after scraping surgery.
Measured: 6-8 weeks after scraping surgery
Secondary outcomes (4)
Evaluation of the effect of the non-stick gel application on the post-surgical fertility 6, 12, and 24 months after scraping surgery.
Evaluation using questionnaires asked by post, mail or phone at 6, 12, and 24 months after scraping surgery.
Measured: 6, 12 and 24 months after scraping surgery
Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery.
Evaluation using questionnaires asked by post, mail or phone at 12 and 24 months after scraping surgery.
Measured: Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery.
Evaluation of post-surgical synechiae stretch and severity
Synechiae stretch and severity will be evaluated by the American Fertility Society classification (rAFS).
Measured: 6-8 weeks after scraping surgery
Consistency assessment between synechiae evaluation performed at the diagnostical hysteroscopy and the synechiae evaluation performed by the 2 experts at the end of the study
Synechiae stretch and severity will be evaluated by the American Fertility Society classification (rAFS).
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study start14 Nov 2014
- Primary completion14 Sep 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine Synechiae After Scraping for Natural MiscarriageStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Benifla, MD-PhD, Principal investigator, Assistance Publique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248376
- Sponsor's protocol ID
- P 130911
- Other IDs
- AOR13019
- Acronym
- HYFACO
- Status last verified
- Jul 2021
- First submitted
- 22 Sep 2014
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Sroussi J, Bourret A, Pourcelot AG, Thubert T, Lesavre M, Legendre G, Tuffet S, Rousseau A, Benifla JL; HYFACO group. Does hyaluronic acid gel reduce intrauterine adhesions after dilation and curettage in women with miscarriage? A Multicentric randomized controlled trial (HYFACO Study). Am J Obstet Gynecol. 2022 Oct;227(4):597.e1-597.e8. doi: 10.1016/j.ajog.2022.05.064. Epub 2022 Jun 3.
PubMed 35667420
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-stick Gel Applicated After Scraping Surgery for Natural Miscarriage and Uterine Synechiae Prevention
- ClinicalTrials.gov ID
- NCT02248376
- Acronym / sponsor ID
- HYFACO / P 130911
- Keywords
- Uterine synechiae Scraping surgery Natural miscarriage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 14 Nov 2014 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to compare efficiency of a non-stick gel application after scraping surgery for natural miscarriage with no non-stick gel application after scraping surgery.
Post-scraping uterine synechiae rate will be established at the diagnostical hysteroscopy 6-8 weeks after surgery.
Detailed description
Women patients coming for natural miscarriage will be compared according to whether a non-stick gel will be applicated or not after scraping surgery.
6-8 weeks after this surgery uterine synechiae rate will be established at a diagnostical hysteroscopy. Proofreading of this exam will be made by 2 experts at the end of the study without knowing the randomization arm.
Long-term follow-up of the patients will be performed to evaluate the effect of the non-stick gel application on post-surgical fertility at 6, 12, and 24 months after scraping surgery using questionnaire asked by post, mail or phone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gel + | Experimental | Drug: GelPatients aged of more than 18 years-old coming for a natural miscarriage who will have the stick gel application at the end of the scraping surgery. |
| Gel - | No intervention | –Patients aged of more than 18 years-old coming for a natural miscarriage who will not have the non-stick gel application at the end of the scraping surgery. |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women patients aged between 18 and 46 years old
- Term ≥ 7 weeks amenorrhea and ≤ 14 weeks amenorrhea
- Blighted ovum or not completed miscarriage or haemorrhagic miscarriage or retention miscarriage
- Consent signature
- Social security coverage
Key exclusion criteria (12 listed)
- Infected miscarriage
- Uncertain diagnosis between miscarriage and extra-uterine pregnancy
- Hydatiform mole
- Uterine synechiae history
- Surgical zone infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GelPatients aged of more than 18 years-old coming for a natural miscarriage who will have the stick gel application at the end of the scraping surgery. | Drug | Gel + |
Primary outcome
Evaluation of post-surgical uterine synechiae rate during a diagnostical hysteroscopy.
Time frame: 6-8 weeks after scraping surgery
Diagnostical hysteroscopy performed 6-8 weeks after scraping surgery.
4 secondary outcomes
Evaluation of the effect of the non-stick gel application on the post-surgical fertility 6, 12, and 24 months after scraping surgery.
Time frame: 6, 12 and 24 months after scraping surgery
Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery.
Time frame: Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery.
Evaluation of post-surgical synechiae stretch and severity
Time frame: 6-8 weeks after scraping surgery
Consistency assessment between synechiae evaluation performed at the diagnostical hysteroscopy and the synechiae evaluation performed by the 2 experts at the end of the study
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Derived from this study: PubMed 35667420Sroussi J, Bourret A, Pourcelot AG, Thubert T, Lesavre M, Legendre G, Tuffet S, Rousseau A, Benifla JL; HYFACO group. Does hyaluronic acid gel reduce intrauterine adhesions after dilation and curettage in women with miscarriage? A Multicentric randomized controlled trial (HYFACO Study). Am J Obstet Gynecol. 2022 Oct;227(4):597.e1-597.e8. doi: 10.1016/j.ajog.2022.05.064. Epub 2022 Jun 3.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis Benifla, MD-PhD principal investigator
Assistance Publique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gel in people with Uterine Synechiae After Scraping for Natural Miscarriage, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of post-surgical uterine synechiae rate during a diagnostical hysteroscopy. (time frame: 6-8 weeks after scraping surgery). 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 NCT02248376, which also lists 1 linked publication.
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 3 Aug 2021.