Consensus statement arising from the 46th Study Group: Preterm Birth
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Health education and policy
- The public and medical professionals need to be aware that it is still not known what initiates the spontaneous onset of labour in women. This makes the prevention and management of preterm labour difficult.
- There is a need to inform the public of the requirement for clinical research and make women aware at the time of the booking that they might be invited to participate in clinical studies.
- The pharmaceutical industry needs to know that it is worthwhile to invest in the development of novel uterine-specific drugs to control uterine activity.
- An improved awareness of the early signs of impending preterm labour is important to improve steroid exposure.
- Regulatory authorities need to be aware that an increase in administrative regulations can impede research and patient care.
Future research
General
- Interdisciplinary research networks should be established.
- Animal research is vital for understanding of the normative process of labour. In addition, animals provide the only means of conducting carefully controlled perturbation challenges that address the pathophysiology of infection, maternal stress and undernutrition, as they impact upon preterm delivery.
- Important lessons can be learned from animal models.
- The elucidation of the physiological pathways of normal delivery is essential. This is a prerequisite for understanding pathological delivery.
- Multidisciplinary approaches are essential for a complete understanding of function at the gene, protein and mechanistic systems levels. Many studies indicate that the time course of changes cannot be followed at a single level.
- Clinical studies are essential to translate the findings from experimental studies into real improvements in clinical care.
- Regulations regarding the use of patient information can impede their use in many ways. This may be detrimental to the consumer. Concerns about protection of information limit the use of such information. This may prevent evaluation of care that patients need in order to make treatment-related decisions.
Clinical
- There is a crisis in clinical research.
- There is a lack of high-quality clinical studies in preterm labour and delivery.
- The quality of clinical care is improved by clinical research and, if studies are inhibited, the care of women in preterm and term labour will be impaired.
- Measures, such as translational research, need to be encouraged to help bridge the gap between scientific understanding and clinical studies in women at risk of preterm labour.
- Any benefits of tocolysis should be investigated in a randomised placebo controlled trial.
- Trials should investigate which tocolytic should be used (if appropriate).
- There are no trials comparing the tocolytic efficacy of atosiban with that of nifedipine. Future research should encourage a randomised placebo-controlled trial.
- The role for progesterone in the management of preterm birth needs to be critically evaluated. Further research should address dose, mode of administration and potential benefits/risks. Current use should be restricted to randomised controlled trials.
- Future clinical trials need to be adequately powered to address neonatal/infant outcome.
- More work is required to evaluate noninvasive methods of monitoring myometrial activity.
- There are ethical issues in clinical studies in preterm labour and neonatology, such as the need to obtain immediate consent. Gaining truly informed consent in emergency situations may be difficult but, equally, it is impractical to consent all patients in order to include a very small proportion that are ultimately eligible for a particular study.
The cervix
- Further investigation on the physiology of cervical ripening at term is likely to be useful in understanding the pathophysiology of preterm delivery.
- Cervical biochemistry and biomechanics should be studied in women with ‘cervical dysfunction’. The development of noninvasive techniques such as the colloscope may be useful. The myometrium
- There is a need to promote basic research into the physiology of the human myometrium.
- Investigations into the mechanisms for the spontaneous onset of labour at term are required. This is a prerequisite for investigating how preterm labour deviates from physiological term labour.
- Targets for effector enzymes (e.g. protein kinases) in human myometrium should be identified. This will help to explain the relative quiescence of the uterus during pregnancy and the transition into labour.
Predisposing factors
- Research is needed to explore additional therapies to reduce the preterm birth rate in women with antiphospholipid syndrome.
- The significance of abnormal intrauterine microbial flora and associated phenomena in spontaneous preterm labour requires further study.
- The role of amniocentesis as a diagnostic test in preterm parturition, particularly spontaneous preterm labour, needs to be evaluated.
- Clinical trials of antibiotics for all genitourinary pathogens in the prenatal period are required.
- No benefit has been shown to date for antibiotic treatment of bacterial vaginosis in low-risk women. However, antibiotics were administered late in pregnancy and further research should address their use earlier in pregnancy.
- Research on the maternal ability to produce an inflammatory response as a result of abnormal colonisation is lacking.
- There is a need to evaluate methods to identify babies infected as a result of abnormal colonisation.
- The outcome of bacterial vaginosis intervention studies should be noninfected mothers and babies rather than numbers of preterm deliveries or days gained.
- Improved understanding of the repair processes in fetal membranes could lead to innovative therapies for preterm prelabour rupture of membranes in the future.
Other interventions
Studies are needed to:
- determine the risks and benefits of repeat steroids
- investigate selective modulation of pulmonary steroid receptors
- clarify which steroid effects are reversible
- evaluate the safety of home-based care of women with preterm prelabour rupture of membranes
- determine the optimal timing for induction of labour in women with preterm prelabour rupture of membranes
- investigate the place of repeated amnioinfusion in early preterm prelabour rupture of membranes to try to prevent fetal pulmonary hypoplasia.
