Last reviewed · How we verify
NCT05643703
Cesarean Section Defect Mechanism and Transvaginal Repair
NA trial testing Suture method in Cesarean Scar Defect; Transvaginal Diverticulum Resection in 300 participants. Not yet recruiting.
30 June 2024
Quick facts
| Lead sponsor | Peking Union Medical College Hospital |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 20 December 2022 |
| Primary completion | 30 June 2024 |
| Estimated completion | 20 November 2026 |
Drugs / interventions tested
- Suture method
Conditions studied
- Cesarean Scar Defect; Transvaginal Diverticulum Resection — all drugs for Cesarean Scar Defect; Transvaginal Diverticulum Resection →
Sponsor
Peking Union Medical College Hospital
Who can join
Adults 18 to 40, female only, with Cesarean Scar Defect; Transvaginal Diverticulum Resection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background and aims: Cesarean section defect (CSD) can cause abnormal uterine bleeding or impaired fertility, which severely impaire the quality of life in women of pregnant age. For women with moderate or severe CSD, surgery can be performed. The objectives of this study is to compare the efficacy and safety of different suture methods in the treatment of transvaginal diverticulum resection, and the underlying mechanism of CSD occurrence. Methods: The patients diagnosed with CSD will be enrolled and randomizely assigned into suture method A and suture method. The fresh isolated tissue and swab of different sites in genital tract will be collected for NGS, microbiome, metabonomics and proteomics analysis. Hypothesis: The menstruation will be analyzed at different following time. The other clinical information will be also collected, including age at surgery, skin-to skin operative time, estimated blood loss (EBL). The perioperative complications, postoperative hopitalization, cost for hospital stay, blasser/intestinal function recovery will also be compared between two gorup. The outcome of fertility will be compared, such as the premature birth, premature rupture of membranes, and rupture of uterus. The clinical manifestation related to CSD and recurrence will be followed. Besides, the underlying mechanism will be analyzed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05643703
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Peking Union Medical College Hospital trials
Trials by the same sponsor.
- NCT07466251 — PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke · Phase 4 · not yet recruiting
- NCT06743321 — Speech-to-speech Voice-cloning Care (SVCC) to Improve ICU-acquired Anxiety for Critically Ill Patients · NA · not yet recruiting
- NCT07590336 — 68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma · Phase 1, PHASE2 · not yet recruiting
- NCT07515976 — Mapping of Genomic Structural Variations in Major Birth Defects · not yet recruiting
- NCT07386756 — Early Precise Identification and Intervention Strategies for Individuals at High Risk of Prediabetes · not yet recruiting
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 NCT05643703 (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 Peking Union Medical College Hospital
- Last refreshed: 9 December 2022
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/NCT05643703.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing