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

Asherman Syndrome Clinical Trial

— ADAB  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04671914
• Other study ID #: Intrauterine adhesions 2020
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: January 2021
• 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
• 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: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 1, 2023
• Est. primary completion date: December 31, 2022
• 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

Related Conditions & MeSH terms

• Abortion Late
• Asherman Syndrome

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
n/a

Sponsors (3)

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

References & Publications (4)

ASHERMAN JG. Amenorrhoea traumatica (atretica). J Obstet Gynaecol Br Emp. 1948 Feb;55(1):23-30. — 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, Brölmann 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. Review. — 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. — 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