Last reviewed · How we verify
NCT03450408: FrIENDly
Foley Bulb Insertion Method: Blind vs. Direct
NA trial testing Method of placement of Foley bulb transcervical dilator in Pregnancy Related in 372 participants. Completed in 1 August 2019.
28 February 2019
Quick facts
| Lead sponsor | The University of Texas Medical Branch, Galveston |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 372 |
| Start date | 28 February 2018 |
| Primary completion | 28 February 2019 |
| Estimated completion | 1 August 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Method of placement of Foley bulb transcervical dilator
Conditions studied
- Pregnancy Related — all drugs for Pregnancy Related →
Sponsor
The University of Texas Medical Branch, Galveston
Who can join
Adults 18 to 50, female only, with Pregnancy Related. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators will compare, in a randomized clinical trial, two methods of placement (placement with a gloved hand vs. placement with a sterile speculum) of a Foley bulb transcervical dilator. The primary outcome is rate of infection.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Foley Bulb Insertion by Blind Placement Compared With Direct Visualization: A Randomized Controlled Trial.
Kuhlmann MJ, Spencer N, Garcia-Jasso C, Singh P, et al · · 2021 · cited 9× · PMID 33278290 · DOI 10.1097/aog.0000000000004182
Verify or expand the search:
- PubMed search for NCT03450408
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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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 NCT03450408 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston
- Last refreshed: 7 May 2020
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/NCT03450408.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing