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

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.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04671914
Acronym
ADAB
Enrollment
200
Registered
2020-12-17
Start date
2021-09-28
Completion date
2025-04-01
Last updated
2024-05-13

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

Conditions

Abortion Late, Asherman Syndrome

Keywords

Asherman Syndrome, Abortion Late, Hyaluronic acid gel, Hysteroscopy

Brief 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. 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).

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

Interventions

DRUGHyaluronic Acid 20 MG/ML Injectable Solution

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

OTHERDilation and curretage

After abortion in II trimester we do D&C.

Sponsors

Bulovka Hospital
CollaboratorOTHER
General University Hospital, Prague
CollaboratorOTHER
Institute for the Care of Mother and Child, Prague, Czech Republic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

Participant will not be informed about usage of hyalobarier gel or not. Care provider - at the time of RCUI the surgeon will know from randomisation if apply the gel or not. The investigator performing evaluation of adhesions by hysteroscopy will be blinded to the arm which the participants belong to.

Intervention model description

Multicenter prospective controlled study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

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) * suspected molar pregnancy * signs of pelvic infection * disagreement with participation in the study

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Intrauterine adhesions after D&C and intrauterine application of hyaluronic acid gell.3 monthTo find out wheter the application of antiadhesive agent with hyaluronic acid has an effect on the frequency of intrauterine adhesions after this procedure.
Prevalence of Intrauterine adhesions after D&C.3 monthDermination 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

Secondary

MeasureTime frameDescription
Pregnancy rate24 monthNumber of pregnancies (pregnancy rate) in the period of 24 months after RCUI in both groups
Delivery rate24 monthNumber of term deliveries in the 24 months after RCUI in both groups

Countries

Czechia

Contacts

Primary ContactJiri Hanacek, MD, Ph.D.
jiri.hanacek@upmd.eu+420604154736

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026