Labor, InducedPhase 2MOLINCT05177510
Mifepristone Outpatient Labour Induction
A Phase 2 study testing Mifepristone in people with Labor, Induced, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor, Induced
- What is being tested?
- Mifepristone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Aug 2023to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women between 36+5 and 41+5 weeks of gestation
- Singleton pregnancy
- Aged 18 years or older
- Unfavourable cervix (Bishop Score less than or equal to 6)
- The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.
Who cannot join
- Breech presentation
- Early labour
- Contraindication to vaginal birth (placenta praevia, transverse lie, known or suspected cephalo-pelvic disproportion or other factor contraindicated to vaginal birth in the opinion of the investigator)
- Fetal growth restriction with oligohydramnios and/or abnormal Dopplers
- Presence of reduced fetal movements requiring urgent delivery, abnormal CTG or recent antepartum haemorrhage requiring immediate delivery
- Medical conditions:
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- sexually transmitted infections (active infections only) ii. bleeding disorders, on anticoagulants, steroid or aspirin therapy iii. prior uterine operations (Caesarean Section or myomectomy)
- Contra-indications to mifepristone including chronic adrenal, hepatic, renal failure
- Hypersensitivity to mifepristone or to any excipients, or malnutrition
- Severe asthma uncontrolled by therapy and inherited porphyria
- Any investigational drug with an expected interaction with mifepristone which has been administered within 30 days prior to the trial drug administration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Chelsea and Westminster Hospital
London
Research Midwife, +442033152560
About this study
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.
Read the detailed description
The study is a double blinded, two arms, multi-centre randomised controlled clinical trial to investigate the clinical effectiveness, safety and resource utilisation of intervention for the induction of labour in women admitted to the hospital. Subjects will be randomised 1:1 to one of the two arms to receive:
Arm 1: Mifepristone + standard of care Arm 2: Placebo + standard of care
The study treatment will commence from the administration of the Mifepristone or placebo. The participants will be assessed 2 days after treatment regimen will be completed as an in-patient.
- Conditions
- Labor, Induced
- Being tested
- Mifepristone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Progestin Antagonist
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone and standard of care | Experimental | Mifepristone 300mg once only and standard of care Receives: Drug: Mifepristone |
| Placebo | Placebo comparator | Placebo 300mg once only and standard of care Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of women in labour or delivered within 2 days of intervention
To determine proportion of women who do not require an induction of labour within 2 days of intervention with mifepristone (superiority).
Measured: up to 2 days after administration of intervention
Secondary outcomes (3)
Change in clinical outcomes
Occurrence of changes in clinical outcomes such as cervical ripening and interval to delivery.
Measured: up to 6 weeks after delivery
Determine whether intervention reduces resource utilisation and patient experience
Patient reported outcomes will be collected following administration of questionnaires after delivery and up to 6 weeks after delivery
Measured: after delivery and up to 6 weeks after delivery
To assess the efficacy and safety of Mifepristone for the outpatient induction of labour
Incidence and severity of adverse events in maternal and neonatal
Measured: up to 6 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start25 Aug 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded parallel group randomised control trial. Intervention arm Mifepristone plus standard care, comparator arm placebo plus standard of care .
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Johnson, Study chair, Chelsea and Westminster NHS Foundation TrustDamon Foster, Study director, Chelsea and Westminster NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177510
- Sponsor's protocol ID
- CW003
- Other IDs
- 2021-004860-93
- Acronym
- MOLI
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2021
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research team wishes to enable any meta-analyses of such trials making appropriate requests. No plan to share IPD has been made at this time.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mifepristone Outpatient Labour Induction
- ClinicalTrials.gov ID
- NCT05177510
- Acronym / sponsor ID
- MOLI / CW003
- Conditions
- Labor, Induced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a double blinded, two arms, multi-centre randomised controlled clinical trial to investigate the clinical effectiveness, safety and resource utilisation of intervention for the induction of labour in women admitted to the hospital. Subjects will be randomised 1:1 to one of the two arms to receive:
Arm 1: Mifepristone + standard of care Arm 2: Placebo + standard of care
The study treatment will commence from the administration of the Mifepristone or placebo. The participants will be assessed 2 days after treatment regimen will be completed as an in-patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded parallel group randomised control trial. Intervention arm Mifepristone plus standard care, comparator arm placebo plus standard of care .
| Arm | Type | Receives |
|---|---|---|
| Mifepristone and standard of care | Experimental | Drug: MifepristoneMifepristone 300mg once only and standard of care |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 300mg once only and standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women between 36+5 and 41+5 weeks of gestation
- Singleton pregnancy
- Aged 18 years or older
- Unfavourable cervix (Bishop Score less than or equal to 6)
- The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.
Key exclusion criteria (11 listed)
- Breech presentation
- Early labour
- Contraindication to vaginal birth (placenta praevia, transverse lie, known or suspected cephalo-pelvic disproportion or other factor contraindicated to vaginal birth in the opinion of the investigator)
- Fetal growth restriction with oligohydramnios and/or abnormal Dopplers
- Presence of reduced fetal movements requiring urgent delivery, abnormal CTG or recent antepartum haemorrhage requiring immediate delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MifepristoneProgestin Antagonist | Drug | Mifepristone and standard of care |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Measure of women in labour or delivered within 2 days of intervention
Time frame: up to 2 days after administration of intervention
To determine proportion of women who do not require an induction of labour within 2 days of intervention with mifepristone (superiority).
3 secondary outcomes
Change in clinical outcomes
Time frame: up to 6 weeks after delivery
Determine whether intervention reduces resource utilisation and patient experience
Time frame: after delivery and up to 6 weeks after delivery
To assess the efficacy and safety of Mifepristone for the outpatient induction of labour
Time frame: up to 6 weeks after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No. Research team wishes to enable any meta-analyses of such trials making appropriate requests. No plan to share IPD has been made at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Johnson study chair
Chelsea and Westminster NHS Foundation Trust
Damon Foster study director
Chelsea and Westminster NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mifepristone in people with Labor, Induced, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tess Cheetham (+442033156825, tess.cheetham@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of women in labour or delivered within 2 days of intervention (time frame: up to 2 days after administration of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.