A continuity of care programme for women at risk of preterm birth in the UK: Process evaluation of a hybrid randomised controlled pilot trial.
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ABSTRACT:
SUBMITTER: Fernandez Turienzo C
PROVIDER: S-EPMC9836307 | biostudies-literature | 2023
REPOSITORIES: biostudies-literature
Publications
A continuity of care programme for women at risk of preterm birth in the UK: Process evaluation of a hybrid randomised controlled pilot trial.
Fernandez Turienzo Cristina C Hull Louise H LH Coxon Kirstie K Bollard Mary M Cross Pauline P Seed Paul T PT Shennan Andrew H AH Sandall Jane J
PloS one 20230112 1
<h4>Background</h4>The development and evaluation of specific maternity care packages designed to address preterm birth remains a public health priority. We aim to evaluate the implementation, context, and potential mechanisms of action, of a new care pathway that combined midwifery continuity of care with a specialist obstetric clinic for women at risk of preterm birth (POPPIE) in London (UK).<h4>Methods</h4>We did a multiphase mixed method triangulation evaluation nested within a hybrid type 2 ...[more]
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| S-EPMC7537886 | biostudies-literature
Project description:BackgroundMidwifery continuity of care models for women at low and mixed risk of complications have been shown to improve women's experiences of care. However, there is limited research on care experiences among women at increased risk of preterm birth. We aimed to explore the experiences of care among women with risk factors for preterm birth participating in a pilot trial (POPPIE) of a midwifery continuity of care model which included a specialist obstetric clinic.MethodsA total of 334 pregnant women identified at increased risk of preterm birth were randomly allocated to either midwifery continuity of care (POPPIE group) or standard maternity care. Women in both groups were followed up at six-to-eight weeks postpartum and were invited to complete a postnatal survey either online or by post. An equal status exploratory sequential mixed method design was chosen to collect and analyse the quantitative postnatal survey data and qualitative interviews data. The postnatal survey included measures of social support, trust, perceptions of safety, quality of care, control during childbirth, bonding and quality of life. Categorical data were analysed with chi-squared tests and continuous data were analysed with t-tests and/or Mann-Whitney U test to measure differences in measures scores among groups. The qualitative interview data were subjected to a thematic framework analysis. Data triangulation brought quantitative and qualitative data together at the interpretation stage.FindingsA total of 166 women completed the survey and 30 women were interviewed (90 and 16 in POPPIE group; 76 and 14 in standard group). We found survey respondents in the POPPIE group, compared to respondents in the standard group, were significantly more likely to report greater trust in midwives (Mann-Whitney U, p<0.0001), greater perceptions of safety during the antenatal care (t-test, p = 0.0138), have a particular midwife to contact when they needed during their pregnancy (t-test, p<0.0001) and the postnatal period (chi-squared, p<0.0001). They reported increased involvement in decisions regarding antenatal, intrapartum and postnatal care (t-test, p = 0.002; p = 0.008; p = 0.006 respectively); and greater postnatal support and advice about: feeding the baby (chi-squared, p<0.0001), handling, settling and looking after the baby (chi-squared, p<0.0001), baby's health and progress (chi-squared, p = 0.039), their own health and recovery (chi-squared, p = 0.006) and who to contact about any emotional changes (chi-squared, p = 0.005). There were no significant differences between groups in the reporting of perceptions of safety during birth and the postnatal period, concerns raised during labour and birth taken seriously, being left alone during childbirth at a time of worries, control during labour, bonding, social support, and physical and mental health related quality of life after birth. Results from qualitative interviews provided insight and depth into many of these findings, with women in the POPPIE group reporting more positive experiences of bonding towards their babies and more positive physical health postnatally.ConclusionsCompared with standard maternity care, women at increased risk of PTB who received midwifery continuity of care were more likely to report increased perceptions of trust, safety and quality of care.Trial registrationISRCTN (Number: 37733900); UK CRN (ID: 31951).
| S-EPMC8059847 | biostudies-literature
Project description:IntroductionWomen from social disadvantage are at greater risk of poor birth outcomes. The midwife-led continuity of care (MCC) model, which offers flexible and relational care from a small team of midwives, has demonstrated improved birth outcomes. In the general population, the impact of MCC on socially disadvantaged women and on birth outcomes is still unclear. This protocol describes a pragmatic evaluation of the MCC model in a socially disadvantaged population.Methods and analysisAn open-labelled individual prospective randomised controlled trial with an internal pilot, process evaluation and economic analysis, from 1 April 2022 to 31 March 2024.Women will be randomly allocated to MCC or standard care as part of usual midwifery practice. Participants and midwives will not be blinded, but researchers will be. An internal pilot will test the feasibility of this process.Participants are those randomised into MCC or standard care, who consent to participate in one of two Born in Bradford (BiB) birth cohort studies. Outcomes are taken from routinely linked health data, supplemented by additional data capture. The sample size is fixed by the capacity of MCC teams, commissioning duration and numbers recruited into the cohort. The estimated maximum fixed sample size is 1,410 pregnancies (minimum 734).Intention to treat (ITT) analysis will be undertaken to assess the impact of MCC on two independent primary outcomes. An economic evaluation will explore the impact on health resource use and a process evaluation will explore fidelity to the MCC model, and barriers/facilitators to implementation from midwives' and women's perspectives.Ethics and disseminationEthical approval has been obtained for the randomisation in midwifery practice, use of the cohort data for evaluation and for the process evaluation. Findings will be published in peer-reviewed journals, presented at conferences and translated into policy briefings.Trial registration numberIsRCTNhttps://doi.org/10.1186/ISRCTN31836167.
| S-EPMC10668235 | biostudies-literature
Project description:BackgroundMask leak and airway obstruction are common with mask ventilation in newborn infants, leading to suboptimal ventilation. We aimed to perform a pilot study measuring respiratory mechanics during one-person and two-person mask ventilation in preterm infants at birth.MethodsInfants less than 30 weeks' gestation were eligible for the study. In the two-person method, one person holds the mask in place and the other provides positive pressure ventilation compared with the standard one-person mask hold. A respiratory function monitor was used in line with a T-piece resuscitator to measure mask leak and airway obstruction. Deferred consent was obtained.ResultsTwenty-five infants were recruited. The mean (SD) birth weight was 920.4 g (188.3), and mean (SD) gestational age was 27.3 weeks (3.0). Percentage mask leak was higher in the one-person mask method (26.4±18.5) compared with the two-person mask method (17.6±9.3) (p=0.018). The mean (SD) expired tidal volume (VTe, mL) in breaths with leak was 3.9 (1.57) in the one-person method compared with 3.05 (1.0) the two-person method (p=0.31). A significantly lower mean (SD) end-tidal carbon dioxide (EtCO2, mm Hg) was measured at 25.3 (9.9) in breaths with mask leak, compared with 30.8 (12.1) in breaths without leak. The breaths with airway obstruction had lower mean EtCO2 (25.9 vs 30.8, p=0.003) and lower mean VTe (1.71 vs 6.95, p<0.001).ConclusionMask leak and airway obstruction are common in resuscitation of preterm infants at birth. The use of the two-person mask technique is effective and it could be a useful option if mask ventilation with the one-person method is not effective.Trial registration numberACTRN12614000245695.
| S-EPMC9906374 | biostudies-literature
Project description:Preterm birth (PTB) is one of major causes of perinatal mortality and neonatal morbidity, but knowledge of its complex etiology is still limited. Here we present cervicovaginal fluid (CVF) protein profiles of pregnant women who subsequently delivered at spontaneous preterm or term, aiming to identify differentially expressed CVF proteins in PTB and term birth. The CVF proteome of women who sequentially delivered at preterm and term was analyzed using isobaric tags for relative and absolute quantitation (iTRAQ) coupled with two-dimensional nanoflow liquid chromatography-tandem mass spectrometry (2D-nLC-MS/MS). We compared the CVF proteome of PTB (n=5) and control subjects (term birth, n=7) using pooled control CVF (term birth, n=20) as spike-in standard. We identified 1294 CVF proteins, of which 605 were newly identified proteins. Of 990 proteins quantified in both PTB and term birth, 52 proteins were significantly up/down-regulated in PTB compared to term birth. The differentially expressed proteins were functionally associated to immune response, endopeptidase inhibitors and structural constituent of cytoskeleton. Taken together, our study provide quantitative CVF proteome profiles of pregnant women who ultimately delivered at preterm and term. These promising results could help to improve the understanding of PTB etiology and to discover biomarkers for asymptomatic PTB.
2021-09-09 | PXD021401 | Pride
Project description:BackgroundExcess weight and unhealthy behaviours (e.g. sedentariness, high alcohol) are common amongst women including those attending breast screening. These factors increase the risk of breast cancer and other diseases. We tested the feasibility and acceptability of a weight loss/behaviour change programme framed to reduce breast cancer risk (breast cancer prevention programme, BCPP) compared to one framed to reduce risk of breast cancer, cardiovascular disease (CVD) and diabetes (T2D) (multiple disease prevention programme, MDPP).MethodsWomen aged 47-73 years with overweight or obesity (n = 1356) in the NHS Breast Screening Programme (NHSBSP) were randomised (1:2) to be invited to join a BCPP or a MDPP. The BCPP included personalised information on breast cancer risk and a web and phone weight loss/behaviour change intervention. The MDPP also included an NHS Health Check (lipids, blood pressure, HbA1c and personalised feedback for risk of CVD [QRISK2] and T2D [QDiabetes and HbA1c]). Primary outcomes were uptake and retention and other feasibility outcomes which include intervention fidelity and prevalence of high CVD and T2D risk. Secondary outcomes included change in weight.ResultsThe BCPP and MDPP had comparable rates of uptake: 45/508 (9%) vs. 81/848 (10%) and 12-month retention; 33/45 (73%) vs. 53/81 (65%). Both programmes had a high fidelity of delivery with receipt of mean (95% CI) 90 (88-98% of scheduled calls, 91 (86-95%) of scheduled e-mails and 89 (76-102) website entries per woman over the 12-month period. The MDPP identified 15% of women with a previously unknown 10-year CVD QRISK2 of ≥ 10% and 56% with 10-year Qdiabetes risk of ≥ 10%. Both groups experienced good comparable weight loss: BCPP 26/45 (58%) and MDPP 46/81 (57%) with greater than 5% weight loss at 12 months using baseline observation carried forward imputation.ConclusionsBoth programmes appeared feasible. The MDPP identified previously unknown CVD and T2D risk factors but does not appear to increase engagement with behaviour change beyond a standard BCPP amongst women attending breast screening. A future definitive effectiveness trial of BCPP is supported by acceptable uptake and retention, and good weight loss.Trial registrationISRCTN91372184 , registered 28 September 2014.
| S-EPMC8690875 | biostudies-literature
Project description:ObjectiveMetabolomics has the potential to reveal novel pathways involved in the pathogenesis of preterm birth (PTB). The objective of this study was to investigate whether the cervicovaginal (CV) metabolome was different in asymptomatic women destined to have a PTB compared with term birth.Study designA nested case-control study was performed using CV fluid collected from a larger prospective cohort. The CV fluid was collected between 20-24 weeks (V1) and 24-28 weeks (V2). The metabolome was compared between women with a spontaneous PTB (n = 10) to women who delivered at term (n = 10). Samples were extracted and prepared for analysis using a standard extraction solvent method. Global biochemical profiles were determined using gas chromatography/mass spectrometry and ultra-performance liquid chromatography/tandem mass spectrometry. An ANOVA was used to detect differences in biochemical compounds between the groups. A false discovery rate was estimated to account for multiple comparisons.ResultsA total of 313 biochemicals were identified in CV fluid. Eighty-two biochemicals were different in the CV fluid at V1 in those destined to have a PTB compared with term birth, whereas 48 were different at V2. Amino acid, carbohydrate, and peptide metabolites were distinct between women with and without PTB.ConclusionThese data suggest that the CV space is metabolically active during pregnancy. Changes in the CV metabolome may be observed weeks, if not months, prior to any clinical symptoms. Understanding the CV metabolome may hold promise for unraveling the pathogenesis of PTB and may provide novel biomarkers to identify women most at risk.
| S-EPMC4877183 | biostudies-literature
Project description:BACKGROUND:Specialised preterm birth clinics care for women at high risk of spontaneous preterm birth. This systematic review assesses current practice within preterm birth clinics globally. METHODS:A comprehensive search strategy was used to identify all studies on preterm birth clinics on the MEDLINE, Embase, PsycINFO, CENTRAL and CINAHL databases. There were no restrictions to study design. Studies were limited to the English language and publications from 1998 onwards. Two reviewers assessed studies for inclusion, performed data extraction and reviewed methodological quality. Primary outcomes were referral criteria, investigations and interventions offered in preterm birth clinics. Secondary outcomes were the timing of planned first and last appointments and frequency of review. RESULTS:Thirty-two records fulfilled eligibility criteria and 20 studies were included in the main analysis following grouping of records describing the same study or clinic. Studies were of mixed study design and methodological quality. A total of 39 clinics were described; outcome data was not available for all clinics. Referral criteria included previous spontaneous preterm birth (38/38, 100%), previous mid-trimester loss (34/38, 89%) and previous cervical surgery (33/38, 87%). All clinics offered transvaginal cervical length scans. Additional investigations varied, including urogenital swabs (16/28, 57%) and fetal fibronectin (8/28, 29%). The primary treatment of choice for a sonographic short cervix was cervical cerclage in 10/33 (30%) clinics and vaginal progesterone in 6/33 (18%), with 10/33 (30%) using multiple first-line options and 6/33 (18%) using a combination of treatments. The majority of clinics planned timing of first review for 12-16 weeks (30/35, 86%) and the frequency of review was usually determined by clinical findings (18/24, 75%). There was a wide variation in gestational age at clinic discharge between 24 and 37 weeks. CONCLUSIONS:There is variation in the referral criteria, investigations and interventions offered in preterm birth clinics and in the timing and frequency of review. Consistency in practice may improve with the introduction of consensus guidelines and national preterm birth prevention programmes. TRIAL REGISTRATION:Systematic review registration number: CRD42019131470.
| S-EPMC6990596 | biostudies-literature
Project description:Preterm birth (PTB) is associated with a high risk of infant mortality and long-term adverse health effects. Glyphosate is a broad-spectrum herbicide applied in agricultural and non-agricultural settings. Studies suggested an association between maternal exposure to glyphosate and PTB among mostly racially homogenous populations, though results were inconsistent. The objective of this pilot study was to inform the design of a larger and more definitive study of glyphosate exposure and adverse birth outcomes in a racially-diverse population. Urine was obtained from 26 women with a PTB as cases and 26 women with a term birth as controls, from participants enrolled in a birth cohort in Charleston, South Carolina. We used binomial logistic regression to estimate associations between urinary glyphosate and the odds of PTB, and multinomial regression to estimate associations between maternal racial identity and urinary glyphosate among controls. Glyphosate was unrelated to PTB (odds ratio (OR) = 1.06, 95% CI: 0.61, 1.86). Women who identified as Black had greater odds (OR = 3.83, 95% CI: 0.13, 111.33) of having categorical "high" glyphosate (> 0.28 ng/mL) and lesser odds (OR = 0.79, 95% CI: 0.05, 12.21) of "low" glyphosate (< 0.03 ng/mL) relative to women who identified as white, suggesting a potential racial disparity, although the effect estimates were imprecise and included the null. Given concerns of potential reproductive toxicity of glyphosate, the results merit confirmation in a larger investigation to determine specific sources of glyphosate exposure, incorporating longitudinal urinary glyphosate measures during pregnancy and a comprehensive measure of diet.
| S-EPMC10073321 | biostudies-literature
Project description:Transcriptome analysis of preterm and term placentas
2021-08-10 | GSE120480 | GEO