Long-term child follow-up after randomized controlled trials evaluating prevention of preterm birth interventions: a systematic review

Presented by Larissa van der Windt

Objective
Although obstetric interventions can have unexpected long-term effects, evaluation of long-term child outcomes is not standardized. The aim of this study is to give an overview of long-term follow-up studies after randomized controlled trials (RCTs) evaluating interventions to prevent preterm birth in asymptomatic pregnant women.

Methods
A search was performed in MEDLINE, Embase and Cochrane Central Library. Titles and abstracts were screened in duplicate. Secondly, eligible RCT’s were crosschecked using WebofScience to find any publication on long term child outcomes of these RCTs (defined as after discharge from hospital). Proportion of RCTs reporting long-term child outcomes was calculated. Also, data on age at follow-up, domains studied, and measurement instrument used were extracted.

Outcomes
181 RCTs were identified evaluating interventions to prevent preterm birth of which 14 assessed long-term child outcomes (8%). Two RCTs performed two follow-up studies, leading to a total of 16 publications. Most follow-up was performed below age of 5 years, but ranged between 6 months and 16 years of age. In 13/16 (81%) of the follow-up publications, neurodevelopment was the primary domain studied. In total, 14 different standardized measurement instruments were used to report on long-term child outcomes. The Ages and Stages Questionnaire (ASQ) was most frequently used in 7/16 (44%) publications.

Conclusion
Only a minority of RCTs evaluating prevention of preterm birth interventions evaluate long-term child outcomes. These outcomes are however crucial for counseling on these interventions. Consensus on a core set of measurement instrument will help to compare and aggregate findings of follow-up studies.

Author
Larissa van der Windt

Tommy’s Clinical Decision Support Tool: a novel digital device for reducing inequalities in preterm birth and stillbirth – an implementation evaluation

Objective

Presented by Jenny Carter

The Tommy’s Tool (a web-based, CE-marked medical device) assesses risk of preterm birth and placental dysfunction more accurately than current methods, and instantly recommends personalised evidenced-based care pathways. This personalisation of care and decision support could reduce preterm birth and stillbirth, whilst addressing variation in care that could lead to the higher rates seen in women from ethnic minority and socially deprived groups. This study evaluated the implementation of Tommy’s Tool in four early-adopter hospitals, in order to inform a cluster RCT and wider scale-up.

Study designs
The NASSS framework (Non-adoption or Abandonment of technology by individuals and difficulties achieving Scale-up, Spread and Sustainability) informed analysis. This implementation research used online surveys (1,300), focus groups (8) and semi-structured interviews (29) to investigate: maternity service user and provider experience; barriers and facilitators to implementation; reach (whether particular groups are excluded and why), fidelity (degree to which the intervention is delivered as intended), and unintended consequences.

Results
Overall, the Tool appears acceptable and easy-to-use. Findings influenced developments of the device and implementation strategy, including those aimed at addressing digital and social exclusion, e.g. health professional registration when women are unable or unwilling to engage. Other findings included: need for high-level local leadership, flexible training, desire to integrate with electronic clinical records.

Conclusion
Personalising risk-assessment and care could reduce preterm birth and stillbirth, as well as inequity in care. Tommy’s Tool has the potential to make providing care easier for health professionals. Findings will inform wider scale-up in other maternity services.

Authors
Jenny Carter, Dilly Anumba, Christy Burden, Siobhán Gillespie, Victoria Komolafe, Basky Thilaganathan, Maria Viner, Hannah Wilson and Jane Sandall on behalf of Tommy’s National Centre for Maternity Improvement.

Preterm Prelabour Rupture Of Membranes (PPROM) before 23 weeks’ gestation: A prospective observational study

Presented by Laura Goodfellow

Objective
Preterm prelabour rupture of membranes (PPROM) under 23 weeks’ gestation is thought to have such high neonatal morbidity that termination of pregnancy for medical reasons (TFMR) is generally offered. There is a paucity of experience in expectant management and parents report wide variations in counselling received. This study aimed to provide population-based pregnancy outcome data.

Study designs
Prospective national population-based cohort study using the UK Obstetric Surveillance System (UKOSS), which encompasses all 194 obstetric units in the UK.

Results
330 women with singleton and 38 with multiple pregnancies and PPROM between 16+0 and 22+6 weeks’ gestation were identified 1/9/19-28/2/21.
The estimated incidence was 0.04% of births nationally. 31% of women had TFMR, to account for these three rates of neonatal outcomes are provided: i) all TFMR excluded; ii) if all with TFMR would have died; iii) if all with TFMR would have survived. Rates are presented i (ii-iii).
Amongst singleton pregnancies livebirth rate was 44% (30-62%), neonatal survival to discharge 26% (16-54%) and 18% (12-49%) of neonates survived without intraventricular haemorrhage grade 3/4 and/or supplemental oxygen at 36 weeks postmenstrual age.
Maternal sepsis rate was 12% for singleton and 26% for twin pregnancies.
Five women became severely unwell with sepsis, 2 died and a further 3 required ITU care.

Conclusion
The UKOSS infrastructure has enabled the largest population-based study of early PPROM. Notable numbers of babies have favourable outcomes; however, morbidity and mortality rates were high for mothers and babies. The data can now be used in counselling families facing this difficult situation.

Authors
Goodfellow, L, Care, A, Curran, C, Roberts, D, Turner, M, Knight, M, Alfirevic, Z

Interventions for women with premature cervical dilatation and exposed fetal membranes to prevent pregnancy loss and preterm birth – a broad systematic review and meta-analysis

Presented by N. Pilarski

Objective
The management of women with premature cervical dilatation and exposed unruptured fetal membranes (CDEM) remains uncertain and controversial. This systematic review aims to summarise all existing evidence for CDEM treatment options.

Study designs
Databases were searched using a prospective protocol (CRD42021286275). Studies were eligible for inclusion across 5 distinct comparison groups if they included women with CDEM and clinical outcomes. Primary outcome was pregnancy loss (miscarriage, stillbirth, neonatal death and termination of pregnancy). Planned subgroup analysis of primary outcome included singletons and twins. Secondary outcomes were assessed including maternal and neonatal morbidities and long-term outcomes. Bias was assessed using Cochrane Risk of Bias tool and Joanna Briggs Institute checklists.

Results
3625 abstracts were screened, and 209 studies (4 randomised controlled trials (RCT)) included across 5 analysis groups (Figure 1). Women receiving emergency cervical cerclage (ECC) were less likely to experience pregnancy loss than with expectant management (RR 0.48 95%CI 0.39-0.59) and more likely to experience pregnancy loss following ECC than ultrasound (USS) or history-indicated cerclage (RR 4.01 95%CI 2.91-5.54). Adjuvant amnioreduction with ECC did not reduce pregnancy loss (RR 1.12 (95% CI 0.73-1.72).

Authors
N. Pilarski, G. Bhogal, J. Hamer, R. Man, V. Hodgetts-Morton, K. Morris

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