Evaluating the use of antiadhesion gel after second trimester abortion procedures
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.
This study is testing if using a special gel after a second trimester miscarriage can help prevent scar tissue from forming in the uterus.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Institute for the Care of Mother and Child, Prague, Czech Republic Academic / other |
| Locations | 3 sites (Prague and 2 other locations) |
| Trial ID | NCT04671914 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the prevalence of intrauterine adhesions following a dilation and curettage (D&C) procedure performed on women who have experienced a second trimester miscarriage. Participants will be randomly assigned to receive either standard care or an additional treatment with hyaluronic acid gel to prevent adhesions. The study will assess the occurrence of adhesions through ultrasound and diagnostic hysteroscopy eight to twelve weeks post-procedure. Additionally, participants will complete a questionnaire regarding their menstrual cycle following the intervention.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 40 who have had a second trimester abortion and wish to conceive in the future.
Not a fit: Patients outside the age range of 18 to 40 or those with a history of previous uterine surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could reduce the incidence of Asherman Syndrome and improve future pregnancy outcomes for women who have experienced a second trimester abortion.
How similar studies have performed: Previous studies have shown promising results with the use of antiadhesion gels in similar surgical contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Prague and 2 other locations
- 1.Lf Uk, Vfn — Prague, Czechia (Recruiting)
- Instiue for Care of Moher and Childe — Prague, Czechia (Recruiting)
- FN Bulovka — Prague, Czechia (Recruiting)
Study contacts
- Study coordinator: Jiri Hanacek, MD, Ph.D.
- Email: jiri.hanacek@upmd.eu
- Phone: +420604154736
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.