Last reviewed · How we verify
NCT05885087
'Extended Balloon Catheter' Labour Induction; a Single Arm Pilot Trial'
NA trial testing Foley or balloon catheter in Labor, Induced in 20 participants. Completed in 1 September 2022.
1 August 2022
Quick facts
| Lead sponsor | University of Botswana |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 February 2022 |
| Primary completion | 1 August 2022 |
| Estimated completion | 1 September 2022 |
| Sites | 1 location across Botswana |
Drugs / interventions tested
- Foley or balloon catheter
Conditions studied
- Labor, Induced — all drugs for Labor, Induced →
Sponsor
University of Botswana
Who can join
Adults 18 to 45, female only, with Labor, Induced. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The overall aim of the single arm pilot study was to assess the effectiveness, safety and acceptance of the 'extended balloon catheter' as a method of induction of labour in women receiving care at Princess Marina Hospital(PMH) in Gaborone, Botswana. The main questions it aimed to answer were whether 'extended balloon catheter' is an effective method of labour induction, whether it results in increased adverse events for the mother and baby and whether it is associated with increased mother satisfaction. Participants were assessed as having a favourable cervix using the modified Bishop score of equal to or more than 7. Three Foley balloon catheters attached side by side were inflated with 60mls each and a gentle traction of 250mls water applied. Delivery interval (time of induction to time of delivery), mode of delivery and Apgar scores were recorded. Adverse maternal and neonatal outcomes were recorded. Participants' satisfaction with the method of induction was assessed using a descriptive scale.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Extended balloon labour induction: A single arm proof of concept trial.
Matshitsa L, Mercy-Nkuba N, Hofmeyr GJ. · · 2023 · cited 1× · PMID 37649714 · DOI 10.1016/j.eurox.2023.100226
Verify or expand the search:
- PubMed search for NCT05885087
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Labor, Induced
Currently open trials in the same condition.
- NCT07237880 — Use of Papaverine to Shorten the Second Stage/Duration of Labor in Pregnant Women After Cervical Ripening by Double-ball · NA · recruiting
- NCT06591247 — Membrane Stripping for Cervical Ripening · NA · recruiting
- NCT07288021 — Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE) · Phase 4 · recruiting
- NCT05177510 — Mifepristone Outpatient Labour Induction · Phase 2 · recruiting
Other University of Botswana trials
Trials by the same sponsor.
- NCT05482217 — The Effectiveness of CBI on Depression and Adherence in HIV Infected Adolescents · NA · completed
- NCT04426448 — Assessment of a Brief Post Traumatic Stress Disorder Intervention for Use in Botswana · NA · 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 NCT05885087 (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 University of Botswana
- Last refreshed: 1 June 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/NCT05885087.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing