Health TrialsbyHealthPanel

Mifepristone Outpatient Labour Induction

ConditionLabor, Induced
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorChelsea and Westminster NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mifepristone

    Drug

    Progestin Antagonist

  • Placebo

    Drug

    Placebo

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Mifepristone and standard of careExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
up to 2 days after administration of intervention

Secondary outcomes

1

Change in clinical outcomes

Occurrence of changes in clinical outcomes such as cervical ripening and interval to delivery.

Time frame
up to 6 weeks after delivery
2

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

Time frame
after delivery and up to 6 weeks after delivery
3

To assess the efficacy and safety of Mifepristone for the outpatient induction of labour

Incidence and severity of adverse events in maternal and neonatal

Time frame
up to 6 weeks after delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chelsea and Westminster NHS Foundation Trust

Lead sponsor

Source ClinicalTrials.gov
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