Does progesterone prophylaxis to prevent preterm labour improve outcome? - A randomized double blind placebo controlled trail: The OPPTIMUM trial is a multi-centre randomised controlled study assessing whether prophylactic vaginal natural progesterone (Utrogestan) 200 mg o.n. at 22 – 34 weeks gestation will, compared to placebo:
· Reduce pre-term delivery before 34+0/40
· Improve neonatal outcomes
· Improve cognitive & neurosensory outcomes at 2 yrs of age
· Be cost-effective management for high risk women
The recruitment period is from 24 August 2010 to 30 November 2011. Neonatal follow-up continues until February 2013.
Women suitable for the trial are those with:
1. Maternal age of 16 or over
2. Singleton pregnancy
3. Ultrasound dating before 16/40
4. No known fetal or chromosomal abnormality
5. No known peanut or progesterone allergy
And at least one of the following:
· History of PTB < 37/40
· History of PPROM ≤ 37/40
· History of miscarriage ≥ 16/40 miscarriage
· Cervical length <25 mm at 18-24+0/40
· Any cervical surgery eg LLETZ
Women with cervical cerclage are eligible for the study. Women taking progesterone up to 18/40 are also eligible.
The study is divided into two phases. In the first phase, consenting eligible women will have a speculum examination for fetal fibronectin (fFN) testing at 22 – 24/40. About 9 in 10 will be screened negative and deemed low risk. They will have no further intervention but will be requested to complete a postnatal postcard. The anticipated 1 in 10 with a positive test, and those women with previous spontaneous preterm birth ≤ 34/40 or current cervical length ≤ 25 mm regardless of their fFN results, will then be randomized in the second phase to take either Utrogestan or placebo pessary every night until 34 weeks. They will complete various questionnaires, study diary and have a hospital visit at 32-34/40. They will also be offered a hospital visit at 28/40. The neonate will have a cranial ultrasound and will be followed-up for 2 years.
Eligible women should be offered the opportunity to participate in the Trial and given Opptimum trial information leaflet. Please refer the woman to see Ms Geraldine Sloane, research nurse on the day of her 22/40 scan for further counselling. Ms Sloane holds OPPTIMUM trial clinics (code: TANST) in antenatal clinic on Tuesday and Thursday 11:30 am – 1:00 pm.
This trial has approval from Ealing Hospital Research and Development Office. Further information may be accessed from www.opptimum.org.uk. Queries may be directed to Mr T L Tan, principal investigator, or Ms G Sloane, research nurse at Ealing Hospital NHS Trust.