Prevalence of Intrauterine Adhesions After D&C With or Without Antiadhesion Gel After Abortion in Second Trimester.
ADAB
1 other identifier
interventional
200
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2021
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedStudy Start
First participant enrolled
September 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedMay 13, 2024
May 1, 2024
3.5 years
December 10, 2020
May 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (2)
Pregnancy rate
24 month
Delivery rate
24 month
Study Arms (2)
Hyaluronic acid gel after D&C
ACTIVE COMPARATORAfter abortion in the II trimester, we provide D\&C and after the procedure, we apply in uterine cavity Hyaluronic acid gel.
Only D&C
ACTIVE COMPARATORAfter abortion, in the II trimester, we provide only D\&C.
Interventions
Application of hyaluronic acid gel into uterine cavity after After abortion in II trimester we do D\&C
After abortion in II trimester we do D\&C.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
1.Lf Uk, Vfn
Prague, 12000, Czechia
Instiue for Care of Moher and Childe
Prague, 14000, Czechia
FN Bulovka
Prague, 14800, Czechia
Related Publications (4)
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.
PMID: 12620443RESULTRai R, Regan L. Recurrent miscarriage. Lancet. 2006 Aug 12;368(9535):601-11. doi: 10.1016/S0140-6736(06)69204-0.
PMID: 16905025RESULTASHERMAN 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.
PMID: 18902559RESULTHooker 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.
PMID: 28390688RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2020
First Posted
December 17, 2020
Study Start
September 28, 2021
Primary Completion
March 31, 2025
Study Completion
April 1, 2025
Last Updated
May 13, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share