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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04671914
Other study ID # Intrauterine adhesions 2020
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 28, 2021
Est. completion date April 1, 2025

Study information

Verified date May 2024
Source Institute for the Care of Mother and Child, Prague, Czech Republic
Contact Jiri Hanacek, MD, Ph.D.
Phone +420604154736
Email jiri.hanacek@upmd.eu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date April 1, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Hyaluronic Acid 20 MG/ML Injectable Solution
Application of hyaluronic acid gel into uterine cavity after After abortion in II trimester we do D&C
Other:
Dilation and curretage
After abortion in II trimester we do D&C.

Locations

Country Name City State
Czechia 1.Lf Uk, Vfn Prague
Czechia FN Bulovka Prague
Czechia Instiue for Care of Moher and Childe Prague

Sponsors (3)

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

Country where clinical trial is conducted

Czechia, 

References & Publications (4)

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. — View Citation

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 — View Citation

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

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 month
Primary 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 3 month
Secondary Pregnancy rate Number of pregnancies (pregnancy rate) in the period of 24 months after RCUI in both groups 24 month
Secondary Delivery rate Number of term deliveries in the 24 months after RCUI in both groups 24 month
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