Prevention of preterm birth in twin pregnancies - “Randomised trial of progesterone versus placebo”

Early vaginal progesterone for the preVention of spontaneous prEterm birth iN TwinS: A randomised, placebo controlled, double-blinded trial- EVENTS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN66445401

Enrollment

1180

Registered

2015-11-19

Start date

2017-05-02

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm birth Pregnancy and Childbirth Preterm birth

Interventions

All women with a twin pregnancy attending for their routine first trimester scan will be invited to participate in this randomised controlled trial of progesterone versus placebo. Informed and written

Eligibility

Sex/Gender

Female

Age

18 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or over 2. Dichorionic diamniotic (DCDA) or monochorionic diamniotic (MCDA) twin pregnancies; 3. Live fetuses at 11-13 weeks of gestation; 4. English or Spanish speaking (otherwise interpreters will be used)

Exclusion criteria

Exclusion criteria: 1. Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks assessment, including nuchal translucency thickness >3.5 mm 2. In MCDA twin pregnancies there are early signs of twin-to-twin transfusion syndrome (TTTS) (20% discordance in crown-rump length [CRL] and/or nuchal translucency [NT]) 3. Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness 4. Hypersensitivity to progesterone 5. Concurrent participation in another drug trial or at any time within the previous 28 days 6. Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol

Design outcomes

Primary

Measure	Time frame
Incidence of spontaneous delivery before 34 weeks (238 days) of gestation.	—

Secondary

Measure	Time frame
1. The incidence of spontaneous preterm birth <37 weeks (259 days) of gestation 2. Birth weight below the 3rd, 5th and 10th centile 3. Rate of stillbirth or neonatal death due to any cause 4. Major adverse outcomes before discharge from the hospital (intraventricular haemorrhage, respiratory distress syndrome, retinopathy of prematurity, or necrotising entercolitis) 5. Need for neonatal special care (admission to a neonatal intensive care unit, ventilation, phototherapy, treatment for proven or suspected sepsis, or blood transfusion)	—

Measure

Time frame

1. The incidence of spontaneous preterm birth <37 weeks (259 days) of gestation 2. Birth weight below the 3rd, 5th and 10th centile 3. Rate of stillbirth or neonatal death due to any cause 4. Major adverse outcomes before discharge from the hospital (intraventricular haemorrhage, respiratory distress syndrome, retinopathy of prematurity, or necrotising entercolitis) 5. Need for neonatal special care (admission to a neonatal intensive care unit, ventilation, phototherapy, treatment for proven or suspected sepsis, or blood transfusion)

—

Countries

England, Spain, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026