EVENTS (version 1.0)

• Research type

  Research Study

• Full title

  Early vaginal progesterone for the prevention of spontaneous preterm birth in twins: A randomised, placebo controlled, double-blinded trial.

• IRAS ID

  192084

• Contact name

  Kypros Nicolaides

• Contact email

  kypros@fetalmedicine.com

• Sponsor organisation

  Fundación para la Formación e Investigación Sanitaria

• Eudract number

  2015-005180-16

• ISRCTN Number

  ISRCTN66445401

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  Twin pregnancies are at increased risk of preterm delivery. While the risk is only approximately 1% in singleton pregnancies, this rises to 15% in twin pregnancies. The fetal consequences of preterm delivery are usually minor if it happens after 32 weeks, but can be very significant, or even fatal, if it happens before 32 weeks. Progesterone has been shown to be effective in reducing the rates of preterm delivery in women with a singleton pregnancy and a history of preterm delivery or a short cervix identified at 22 weeks. To-date, progesterone has not been shown to be effective in twin pregnancies, but this may be due to starting progesterone too late in the pregnancy or using too low a dose.

  We wish to study the effectiveness of using a particular progesterone, Utrogestan, starting at 11-14 weeks' of pregnancy in preventing preterm delivery in twins. All eligible women with twin pregnancies attending for their first ultrasound scan will be offered the chance to participate in this trial. Those women choosing to participate will be given either progesterone suppositories (Utrogestan 300 mg ) or placebo suppositories twice a day until 34 weeks', and neither the patients nor the doctors will know which suppositories they are receiving.

  We hope to show that by starting a higher dose of progesterone early in the pregnancy, at around the time of the first trimester scan, this will significantly reduce the chances of premature delivery in twins.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  16/LO/0066

• Date of REC Opinion

  22 Feb 2016

• REC opinion

  Further Information Favourable Opinion