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NCT03169478
Intrauterine Balloon Dilatation Therapy in the Prevention of Adhesion Formation After Hysteroscopic Myomectomy
NA trial testing multiple myoma IUB dilatation group in Intrauterine Adhesion in 112 participants. Status unknown.
30 May 2019
Quick facts
| Lead sponsor | Fu Xing Hospital, Capital Medical University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 112 |
| Start date | 30 May 2017 |
| Primary completion | 30 May 2019 |
| Estimated completion | 31 July 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- multiple myoma IUB dilatation group
Conditions studied
- Intrauterine Adhesion — all drugs for Intrauterine Adhesion →
Sponsor
Fu Xing Hospital, Capital Medical University
Who can join
Adults 18 to 45, female only, with Intrauterine Adhesion. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Transcervical resection of submucous myomas (TCRM) is nowadays considered necessary if it is associated with infertility or miscarriage or menorrhagia. Nevertheless, one possible risk of hysteroscopic myomectomy is the formation of intrauterine adhesion (IUA) at the site of resection. The development of IUA arising from trauma to the basalis layer of the endometrium during hysteroscopy can result in infertility, recurrent miscarriages, amenorrhea, dysmenorrhea, or abnormal placentation. Several measures have been proposed in an effort to decrease the formation of post-surgical intrauterine adhesions. Additionally, physical barriers such as balloon catheters or intrauterine devices have been used in the postoperative period. Despite years of studies evaluating prevention strategies for intrauterine adhesion formation after operative hysteroscopy, it is still unclear which strategy is most effective because there has never been any formal properly powered randomized, control trial to examine the efficacy of the various methods used to prevent adhesion reformation. In this prospective, randomized, controlled study, the investigators wish to examine the efficacy of intrauterine balloon dilatation therapy in the early postoperative period in preventing adhesion formation after transcervical resection of submucous myomas.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03169478
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Related trials
Other recruiting trials for Intrauterine Adhesion
Currently open trials in the same condition.
- NCT07421908 — Investigating the Association Between Diagnostic and Therapeutic Management Models and Prognosis of Intrauterine Adhesio · NA · recruiting
- NCT06645379 — Application of Platelet-rich Plasma (PRP) in Reproductive Medicine · NA · recruiting
- NCT05257213 — Heparin Solution Versus Anti-adhesion Barrier Gel for Intrauterine Adhesions Prevention After Operative Hysteroscopy · NA · recruiting
Other Fu Xing Hospital, Capital Medical University trials
Trials by the same sponsor.
- NCT06862089 — A Prospective Study Evaluating the Impact of Conservative Management on Retained Products of Conception and EMV · recruiting
- NCT06608407 — Platelet Rich Plasma in the Prevention of Adhesion Reformation · NA · enrolling by invitation
- NCT05085067 — The Efficacy of Auto-cross Linked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Rese · NA · recruiting
- NCT04835272 — Comparison of the Decannulation Protocol With Suctioning and Capping in Severe Acquired Brain Injury Patients · NA · unknown
- NCT04930913 — Three-dimensional Ultrasound Applying in Assessment of Intrauterine Adhesions · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03169478 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fu Xing Hospital, Capital Medical University
- Last refreshed: 7 June 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03169478.
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