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

• Register: ISRCTN
• Last refreshed on: 8 February 2021
• Main ID: ISRCTN66445401
• Date of registration: 19/11/2015
• Prospective Registration: Yes
• Primary sponsor: Foundation for Health Education & Research (Fundación para la Formación e Investigación Sanitaria)
• Public title: Prevention of preterm birth in twin pregnancies - “Randomised trial of progesterone versus placebo”
• Scientific title: Early vaginal progesterone for the preVention of spontaneous prEterm birth iN TwinS: A randomised, placebo controlled, double-blinded trial- EVENTS
• Date of first enrolment: 02/05/2017
• Target sample size: 1180
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN66445401
• Study type: Interventional
• Study design: Multi-centre double-blind placebo-controlled randomised trial (Prevention)
• Phase: Phase III

Countries of recruitment

Spain, United Kingdom

Contacts

• Name: Catalina De Paco

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Preterm birth
Pregnancy and Childbirth
Preterm birth

Intervention(s)

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 consent will be sought from those agreeing to participate in the study. Participants are then randomly allocated to the treatment group or the placebo group.

Treatment group: Participants are required to insert a 300mg progesterone suppository twice daily until 34 weeks’ gestation or earlier in the event of preterm delivery.

Control Group: Participants are required to insert a 300mg placebo suppository twice daily until 34 weeks’ gestation or earlier in the event of preterm delivery.

Follow­-up clinical visits for all participants will be carried out at every 2-4 weeks. They will also be followed up by a further telephone interview 30 days after the last dose of medication.

Primary Outcome(s)

Incidence of spontaneous delivery before 34 weeks (238 days) of gestation.

Secondary Outcome(s)

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)

Secondary ID(s)

N/A

2015-005180-16

Source(s) of Monetary Support

Fetal Medicine Foundation

Ethics review

Status:
Approval date:
Contact:

London Bridge REC, 22/02/2016, ref: 16/LO/0066

Results

• Results available: Yes
• Date Completed: 01/12/2019