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

NCT ID: NCT04671914

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2025-04-01

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

Conditions

Asherman Syndrome; Abortion Late

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Hyaluronic acid gel after D&C

After abortion in the II trimester, we provide D\&C and after the procedure, we apply in uterine cavity Hyaluronic acid gel.

Group Type: ACTIVE_COMPARATOR

Hyaluronic Acid 20 MG/ML Injectable Solution

Intervention Type: DRUG

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

Dilation and curretage

Intervention Type: OTHER

After abortion in II trimester we do D\&C.

Only D&C

After abortion, in the II trimester, we provide only D\&C.

Group Type: ACTIVE_COMPARATOR

Dilation and curretage

Intervention Type: OTHER

After abortion in II trimester we do D\&C.

Interventions

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

Intervention Type: DRUG

Dilation and curretage

After abortion in II trimester we do D\&C.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bulovka Hospital

OTHER

Sponsor Role: collaborator

General University Hospital, Prague

OTHER

Sponsor Role: collaborator

Institute for the Care of Mother and Child, Prague, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

1.Lf Uk, Vfn

Prague, , Czechia

Site Status: RECRUITING

Instiue for Care of Moher and Childe

Prague, , Czechia

Site Status: RECRUITING

FN Bulovka

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Jiri Hanacek, MD, Ph.D.

Role: CONTACT

jiri.hanacek@upmd.eu

+420604154736

Facility Contacts

Michal Mara, Prof

Role: primary

michal@drmara.cz

Jiří Hanáček, MD

Role: primary

jiri.hanacek@upmd.eu

604154736

Role: backup

jiri.hanacek@upmd.eu

Peter Koliba, MD

Role: primary

peter.koliba@gmail.com

References

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.

Reference Type: RESULT

PMID: 12620443 (View on PubMed)

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

Reference Type: RESULT

PMID: 16905025 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18902559 (View on PubMed)

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 and curettage in women with at least one previous curettage: short-term outcomes of a multicenter, prospective randomized controlled trial. Fertil Steril. 2017 May;107(5):1223-1231.e3. doi: 10.1016/j.fertnstert.2017.02.113. Epub 2017 Apr 6.

Reference Type: RESULT

PMID: 28390688 (View on PubMed)

Other Identifiers

Intrauterine adhesions 2020

Identifier Type: -

Identifier Source: org_study_id