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NCT03199820: PROBIT-F
Balloon Catheter Versus Propess for Labour Induction
Phase 4 trial testing Cook cervical balloon in Childbirth Problems in 120 participants. Status unknown.
31 January 2019
Quick facts
| Lead sponsor | St George's, University of London |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | health services research |
| Enrollment | 120 |
| Start date | 22 September 2017 |
| Primary completion | 31 January 2019 |
| Estimated completion | 31 May 2019 |
| Sites | 2 locations across United Kingdom |
Drugs / interventions tested
- Cook cervical balloon
- Prostin E2 Vaginal Suppository — full drug profile →
Conditions studied
- Childbirth Problems — all drugs for Childbirth Problems →
- Labor Complication — all drugs for Labor Complication →
Sponsor
St George's, University of London
Who can join
Adults 18 to 50, female only, with Childbirth Problems or Labor Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will randomise low-risk women to compare the effectiveness of trans-cervical balloon catheter for pre-induction cervical ripening for out-patient induction of labour with current practice (Propess). Women will be randomised to two treatment groups. The investigators wish to explore if such a trial is feasible, acceptable to women and what data collection is required for a future trial. Since no data exist, the investigators propose a study with approximately 60 women in each arm across two recruiting sites.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Prostaglandin insert dinoprostone versus trans-cervical balloon catheter for outpatient labour induction: a randomised controlled trial of feasibility (PROBIT-F).
Bhide A, Sedgwick P, Barrett B, Cupples G, et al · · 2020 · cited 13× · PMID 32821419 · DOI 10.1186/s40814-020-00661-7
Verify or expand the search:
- PubMed search for NCT03199820
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Childbirth Problems
Currently open trials in the same condition.
- NCT06204757 — Study of the Identification of Childbirth Trauma in the Birth Room by Midwives. · active not recruiting
Other St George's, University of London trials
Trials by the same sponsor.
- NCT07012421 — Community Antibiotic Use, Susceptibility and ResisTance Among Patients With Urinary Tract Infections (CAST-UTI) · recruiting
- NCT06411405 — Using Machine Learning to Model Early-onset Neonatal Sepsis Risk in Uganda and Zimbabwe · unknown
- NCT05950984 — Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK) · completed
- NCT05855889 — Observational Study of the Management of Infants With Congenital CMV · recruiting
- NCT06159218 — Eosinophilic Oesophagitis Assessment With String Testing · NA · 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 NCT03199820 (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 St George's, University of London
- Last refreshed: 9 April 2019
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/NCT03199820.
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