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Mifepristone Outpatient Labour Induction

Study acronym: MOLI
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Dec 31, 2026 → Mar 31, 2027
See other at-risk trials from Chelsea and Westminster NHS Foundation Trust

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 31, 2026 to Mar 31, 2027
    • Study completion pushed from Dec 31, 2026 to May 31, 2027
    v6
  2. Primary completion date: Oct 9, 2025 to Dec 31, 2026v5 Show 4 more changesShow less
    • Study sites: 3 to 1
    • Study completion date: Oct 9, 2026 to Dec 31, 2026
    • Eligibility criteria shortened, about 34 words
    • Secondary endpoints: details revised at 1 of 3 entries
  3. Phase: Phase 3 to Phase 2v4 Show 4 more changesShow less
    • Primary endpoint revised
    • Study sites: 2 to 3
    • Eligibility criteria expanded, about 19 words
    • Study description shortened, about 1 word
  4. Trial status: Not Yet Recruiting to Recruitingv3 Show 6 more changesShow less
    • Primary completion date: Feb 2024 to Oct 9, 2025
    • Start date changed from estimate of Aug 2022 to Aug 25, 2023
    • Primary endpoint revised
    • Study completion date: Mar 2024 to Oct 9, 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints revised (3)
  5. Start date: Feb 2022 to Aug 2022v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The number of women having an induction of labour is increasing and is currently used in 33% of pregnancies for a range of medical reasons. The majority of women are admitted to hospital to have their labour induced, using methods which are protracted and associated with a poor birth experience, making them both costly and unpopular. Further, current methods of outpatient induction are unsuitable, unsafe and/or have a poor acceptability. The COVID-19 pandemic has driven a reduction in the number of face-to-face interactions taking place across all areas of medicine. Proving the efficacy and safety of Mifepristone would significantly reduce pre-labour admission rates and hospital length of stay for pregnant women, who are at particularly higher risk of COVID-19, and reduce delivery costs.
Trial Details
NCT Number NCT05177510
Lead Sponsor Chelsea and Westminster NHS Foundation Trust
Conditions
(from sponsor)		 Labor, Induced
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov