Prevalence of Intrauterine Adhesions After D&C With or Without Antiadhesion Gel After Abortion in Second Trimester.
- Conditions
- Asherman SyndromeAbortion Late
- Interventions
- Drug: Hyaluronic Acid 20 MG/ML Injectable SolutionOther: Dilation and curretage
- Registration Number
- NCT04671914
- Lead Sponsor
- Institute for the Care of Mother and Child, Prague, Czech Republic
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hyaluronic acid gel after D&C Dilation and curretage After abortion in the II trimester, we provide D\&C and after the procedure, we apply in uterine cavity Hyaluronic acid gel. Only D&C Dilation and curretage After abortion, in the II trimester, we provide only D\&C. Hyaluronic acid gel after D&C Hyaluronic Acid 20 MG/ML Injectable Solution After abortion in the II trimester, we provide D\&C and after the procedure, we apply in uterine cavity Hyaluronic acid gel.
- Primary Outcome Measures
Name Time Method Prevalence of Intrauterine adhesions after D&C. 3 month 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
Prevalence of Intrauterine adhesions after D&C and intrauterine application of hyaluronic acid gell. 3 month To find out wheter the application of antiadhesive agent with hyaluronic acid has an effect on the frequency of intrauterine adhesions after this procedure.
- Secondary Outcome Measures
Name Time Method Pregnancy rate 24 month Number of pregnancies (pregnancy rate) in the period of 24 months after RCUI in both groups
Delivery rate 24 month Number of term deliveries in the 24 months after RCUI in both groups
Trial Locations
- Locations (3)
1.Lf Uk, Vfn
🇨🇿Prague, Czechia
FN Bulovka
🇨🇿Prague, Czechia
Instiue for Care of Moher and Childe
🇨🇿Prague, Czechia