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NCT01819467
A Randomized Controlled Trial to Reduce Adhesions Following a Primary Cesarean Section
NA trial testing Seprafilm in Tissue Adhesions in 29 participants. Terminated before completion.
1 September 2016
Quick facts
| Lead sponsor | South East Area Health Education Center, Wilmington, NC |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 29 |
| Start date | 1 June 2014 |
| Primary completion | 1 September 2016 |
| Estimated completion | 1 September 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Seprafilm — full drug profile →
Conditions studied
- Tissue Adhesions — all drugs for Tissue Adhesions →
Sponsor
South East Area Health Education Center, Wilmington, NC
Who can join
12 and older, female only, with Tissue Adhesions. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Adhesion Formation Following a Primary C-section With and Without Adhesion Barrier
Time frame: 21 months
Study was terminated due to too many protocol deviations. There were no outcome measures analyzed.
Sponsor's own description
The primary objective of this study is to determine whether the use of Seprafilm reduces the incidence rate of adhesion formation following a primary C-section. A secondary objective of the study will be to determine whether or not a correlation between the adhesion score and the difficulty or delay in delivery of the infant exists.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01819467
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other South East Area Health Education Center, Wilmington, NC trials
Trials by the same sponsor.
- NCT03545503 — Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation · Phase 4 · completed
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 NCT01819467 (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 South East Area Health Education Center, Wilmington, NC
- Last refreshed: 24 July 2023
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/NCT01819467.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing