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Does progesterone propylaxis to prevent preterm labour improve outcome? (OPPTIMUM)

Document type: Projects: In progress/completed
Document language: English
Uploaded By: Allan Colver (allancolver)
Date Uploaded: 2012/01/12 13:47:30.802 GMT+1
URL to a webpage or document based online: http://www.mrc.ac.uk/ResearchPortfolio/Grant/Record.htm?GrantRef=G0700452&CaseId=10161

Basic Information

Authors: Professor J Norman, University of Edinburgh
Published on Date: 2008
Funding source project: Medical Research Council (MRC)
Abstract:

Background:
Preterm delivery is the single biggest cause of perinatal mortality and morbidity, accounting for 75% of neonatal deaths. Two recent studies (da Fonseca et al. 2003; Meis, et al. 2003) and four meta-analyses (Sanchez-Ramos et al. 2005; Dodd, et al. 2005; Mackenzie et al 2006, Coomaraswamy et al 2006) have suggested that progesterone prevents preterm delivery in high risk women with singleton pregnancy. However, none of the meta-analyses demonstrated a convincing effect on perinatal mortality or morbidity and no studies have examined the important longer-term neurodevelopmental outcomes. We therefore concur with the conclusions of most of the meta-analyses and editorials that the routine use of progestational agents cannot be justified without evidence of improved outcomes for babies.

Rationale for trial:
The proposed trial will quantify the magnitude of the obstetric, neonatal and child health benefits of vaginal progesterone treatment and evaluate the cost effectiveness of treatment.

Design of trial in high-risk women:
Women will be recruited if there is an appropriate history or a short (less than 25 mm) cervix on ultrasound scan and a positive fetal fibronectin (fFN). Women will be randomised to receive either vaginal progesterone 200mg, or placebo, from 22 weeks gestation daily until 34 weeks gestation. The primary obstetric outcome is delivery before 34 weeks of gestation. The primary neonatal outcome is a composite of death and major morbidity. The primary childhood outcome is neurodevelopmental performance at 2 years of age (Bayley 2006). A formal economic evaluation is a key part of this study.

Implications for practice:
The results will be used to inform policy and practice by determining the clinical and cost effectiveness of progesterone for obstetric, neonatal and childhood outcomes in women at high risk of preterm birth. We will use an inexpensive generic formulation of natural progesterone so the results can be immediately translated into improved patient care if progesterone administration is indicated.

Expertise and personnel:
The applicants include obstetricians and neonatologists (with expertise in both preterm labour and in conducting clinical trials), statisticians, clinical triallists, a health economist, an expert on ascertaining consumer views. We have benefited from advice from lay collaborators. Thirty centres in the UK, with a combined annual delivery rate of 140,000 births have agreed to participate in this trial.


Riche Classification

Taxonomy:
Demography: All , Neonatal: 0-27 days , 1-4 years , Gestation: , Neonatal: , Infant (first year of life / baby not walking): , Conception ,
Child Related Topics: Health care involving children , Midwives ,
Health issues, determinants and measures: Indicators of disability and need , Family planning; Reproductive Health and Childbirth , Infant mortality data , Morbidity , Disabilities , Neurological diseases and disorders , Births (live and still) , Infant mortality data , Common problems , Female hormones , Pregnancy ,
Languages and Geographical Perspective: United Kingdom , English ,
Study type / scale / state of progress / setting: Randomised controlled trial , Evaluation research - of policy or of practice, interventions. , Health care facility , Selected representative localities within a country , Ongoing ,