MOLI study

Short title: MOLI
Full title: Mifepristone Outpatient Labour Induction
IRAS number: 1004485
Sponsor reference: CW003
Version: 8.0 (4 Dec 2024)
Chief Investigator: Prof Mark R Johnson
Principal Investigator (CWH): Dr Angela Yulia

What is the MOLI study?

Induction of labour happens in around 1 in 3 pregnancies in the UK. Some women and birthing people tell us current methods can be slow, uncomfortable and not always successful. MOLI is a randomised, double-blind study testing whether a medicine called mifepristone given before induction could improve outcomes compared with usual care.

Mifepristone is already widely and safely used in pregnancy care for other indications. It is not currently used to induce labour in the NHS because we need more evidence on effectiveness for this purpose. Existing studies suggest it may increase the chance of labour starting before the booked induction date, shorten hospital stay and improve the chance of vaginal birth. MOLI is designed to test this.

Who can take part?

  • Currently pregnant and otherwise well
  • Uncomplicated pregnancy
  • Considering induction of labour from 36+5 to 41+5 weeks
  • No previous caesarean section

The study plans to enrol 400 participants. Participation is voluntary and you can withdraw at any time without giving a reason.

What does taking part involve?

This is a randomised, placebo-controlled, double-blind trial. You will receive either mifepristone + standard care or placebo + standard care (1:1). Allocation can be revealed if clinically necessary.

Study timeline

Initial discussion

Eligibility confirmed and questions answered.

Visit 1: Two days before induction

  • Observations and CTG
  • Vaginal examination if needed to access cervix
  • One dose of study tablet (mifepristone or placebo)
  • Please avoid grapefruit juice until after birth

Visit 2: Induction date (if not already in labour)

  • Observations, CTG and vaginal examination
  • If cervix closed: Propess pessary suggested
  • If slightly open: balloon or other methods may be discussed
  • If open enough: move to labour ward for amniotomy; oxytocin may be used at a lower starting rate

If you have more than 2 contractions in 10 minutes, attend the Maternity Assessment Suite for review.

Visit 3: After birth

  • Baby’s blood sugar checks (two heel-pricks 3–8 hours after birth)
  • Routine observations and a short experience questionnaire

Visit 4–6 weeks after birth (phone)

  • 20-minute call about you and your baby’s wellbeing and any side-effects

Potential benefits

Mifepristone may help labour start before the induction date, increase the chance of successful induction and reduce time in hospital. Your participation will also help improve care for others.

Possible risks and side-effects

  • Common (1 in 10 to 1 in 100): nausea, vomiting, diarrhoea
  • Uncommon (1 in 100 to 1 in 1,000): low blood pressure, skin rash
  • Rare (<1 in 1,000): headache, hot flushes, dizziness, hives, skin inflammation, feeling unwell
  • Very rare (<1 in 10,000): swelling under the skin

Mifepristone can increase sensitivity to prostaglandins and oxytocin. To reduce this risk, a removable prostaglandin pessary is used and oxytocin starts at a lower rate.

Optional research samples

You can take part with or without extra samples. If you agree, blood samples may be taken before the tablet and 2 days later. If you have a caesarean section, small tissue samples from the uterine incision edge and placenta/membranes may be collected. Samples are coded, stored frozen for up to 10 years and may be analysed outside the UK. Genetic and biomarker testing may be performed. You may consent to future approved obstetrics research use.

Confidentiality and data protection

We use only the information needed for research from you, your baby, your medical records and your GP. Identifiable data are restricted to authorised staff. Coded data may be shared within or outside the UK with approved partners under legal safeguards. Personal and research data are securely archived for 25 years.

Approvals, sponsor and funding

Sponsor: Chelsea and Westminster Hospital NHS Foundation Trust
Funder: Nordic Pharma
Ethical approval: London – Fulham Research Ethics Committee

Problems or complaints

Please speak to the study team in the first instance. You can also contact PALS on 020 3315 6727 or chelwest.cwpals@nhs.net.

Out of hours: 020 3315 6000, option 1.

Contact us

Research midwives (MOLI)
chelwest.researchmidwives@nhs.net
T: 07825 725433