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Efficacy of a midwife-coordinated, individualized, and specialized maternity care intervention (ChroPreg) in addition to standard care in pregnant women with chronic disease: protocol for a parallel randomized controlled trial.

ABSTRACT: BACKGROUND AND OBJECTIVES:The number of women of childbearing age with chronic diseases is rising. Evidence has shown that obstetric complications and poor psychological well-being are more prevalent among this group, in addition to these women reporting experiences of less than satisfactory care. More research is needed to investigate how to best meet the special needs of this group during pregnancy and postpartum. Previous research has shown that care coordination, continuity of care, woman-centered care, and specialized maternity care interventions delivered to women with high-risk pregnancies can improve patient-reported outcomes and pregnancy outcomes and be cost-effective. However, no previous trials have examined the efficacy and cost-effectiveness of such interventions among pregnant women with chronic diseases. This paper describes the protocol of a randomized controlled trial (RCT) of a midwife-coordinated, individualized and specialized maternity care intervention (ChroPreg) as an add-on to standard care for pregnant women with chronic diseases. METHODS/DESIGN:This two-arm parallel group RCT will be conducted from October 2018 through June 2020 at the Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet, Denmark. Pregnant women with chronic diseases are invited to participate; women will be randomized and allocated 1:1 to the ChroPreg intervention plus standard care or standard care alone. The ChroPreg intervention consists of three main components: (1) coordinated and individualized care, (2) additional ante- and postpartum consultations, and (3) specialized midwives. The primary outcome is length of hospital stay during pregnancy and in the postpartum period, and secondary outcomes are psychological well-being (five-item World Health Organization Well-Being Index, Edinburgh Postnatal Depression Scale, Cambridge Worry Scale), health-related quality of life (12-Item Short Form Health Survey), patient satisfaction (Pregnancy and Childbirth Questionnaire), number of antenatal contacts, and pregnancy and delivery outcomes. Data are collected via patient-administered questionnaires and medical records. DISCUSSION:This trial is anticipated to contribute to the field of knowledge on which planning of improved antenatal, intra-, and postpartum care for women with chronic disease is founded. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03511508 . Registered April 27, 2018.

SUBMITTER: de Wolff MG

PROVIDER: S-EPMC6537398 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Efficacy of a midwife-coordinated, individualized, and specialized maternity care intervention (ChroPreg) in addition to standard care in pregnant women with chronic disease: protocol for a parallel randomized controlled trial.

de Wolff Mie Gaarskjaer MG Johansen Marianne M Ersbøll Anne S AS Rosthøj Susanne S Brunsgaard Anne A Midtgaard Julie J Tabor Ann A Hegaard Hanne Kristine HK

Trials 20190528 1

<h4>Background and objectives</h4>The number of women of childbearing age with chronic diseases is rising. Evidence has shown that obstetric complications and poor psychological well-being are more prevalent among this group, in addition to these women reporting experiences of less than satisfactory care. More research is needed to investigate how to best meet the special needs of this group during pregnancy and postpartum. Previous research has shown that care coordination, continuity of care, ...[more]

PMID: 31138296

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Project description:BackgroundLow risk pregnancy ending in a vaginal birth is best served and guided by a midwife. Utilizing a midwife in such cases offers many emotional and economic advantages and does not increase the risks for mother or neonate. However, women's experience and satisfaction of midwife-led maternity care is rarely reported in China. The primary objective of this study is to describe the experience of Chinese women receiving midwife-led maternity care, and to report their satisfaction level of the experience.MethodsThe study is a cross-sectional survey of 4192 women who had natural birth from March-June 2019 in a maternity care center, Shanghai, China. We used a self-administered questionnaire addressing items related to women's experience during childbirth, as well as their satisfaction with midwife-led maternity care. We also included demographic and perinatal characteristics of each participant. Descriptive statistics and correlations analysis between groups of different experience and satisfaction were used.ResultsIn this sample, 87.7% of women had a Doula and a family member present during childbirth. Epidural anesthesia was used in 75.6% and episiotomy was needed in 23.2%. Free positioning during the first stage of labor and free positioning during the second stage of labor and delivery were adopted in 84.3 and 67.9% of the cases, respectively. Moderate to severe perineal pain and moderate to severe perineal edema were reported in 43.1 and 12.2% of the participants, respectively. High satisfaction level was found when there was midwife-led prenatal counseling and presence of Doula and family member, Lamaze breathing techniques, warm perineal compresses, epidural anesthesia, free positioning during the first stage of labor, and midwifes' postpartum guidance. Negative satisfaction was seen with perineal pain and edema.ConclusionWomen in this survey generally had high satisfaction with midwife-led maternity care. This satisfaction is probably felt because of the prenatal counseling by the midwife and allowing a Doula and a family member in the room during childbirth. Other intangible factors to improve the satisfaction level were Lamaze breathing techniques, warm perineal compresses, epidural anesthesia, free positioning during first stage of labor, and early skin to skin contact.

Project description:ObjectiveTo compare maternal and neonatal birth outcomes and morbidities associated with the intention to give birth in a freestanding primary level midwife-led maternity unit (PMU) or tertiary level obstetric-led maternity hospital (TMH) in Canterbury, Aotearoa/New Zealand.DesignProspective cohort study.Participants407 women who intended to give birth in a PMU and 285 women who intended to give birth at the TMH in 2010-2011. All of the women planning a TMH birth were 'low risk', and 29 of the PMU cohort had identified risk factors.Primary outcomesMode of birth, Apgar score of less than 7 at 5 min and neonatal unit admission.Secondary outcomeslabour onset, analgesia, blood loss, third stage of labour management, perineal trauma, non-pharmacological pain relief, neonatal resuscitation, breastfeeding, gestational age at birth, birth weight, severe morbidity and mortality.ResultsWomen who planned a PMU birth were significantly more likely to have a spontaneous vaginal birth (77.9%vs62.3%, adjusted OR (AOR) 1.61, 95% CI 1.08 to 2.39), and significantly less likely to have an instrumental assisted vaginal birth (10.3%vs20.4%, AOR 0.59, 95% CI 0.37 to 0.93). The emergency and elective caesarean section rates were not significantly different (emergency: PMU 11.6% vs TMH 17.5%, AOR 0.88, 95% CI 0.55 to 1.40; elective: PMU 0.7% vs TMH 2.1%, AOR 0.34, 95% CI 0.08 to 1.41). There were no significant differences between the cohorts in rates of 5 min Apgar score of <7 (2.0%vs2.1%, AOR 0.82, 95% CI 0.27 to 2.52) and neonatal unit admission (5.9%vs4.9%, AOR 1.44, 95% CI 0.70 to 2.96). Planning to give birth in a primary unit was associated with similar or reduced odds of intrapartum interventions and similar odds of all measured neonatal well-being indicators.ConclusionsThe results of this study support freestanding midwife-led primary-level maternity units as physically safe places for well women to plan to give birth, with these women having higher rates of spontaneous vaginal births and lower rates of interventions and their associated morbidities than those who planned a tertiary hospital birth, with no differences in neonatal outcomes.

Project description:BackgroundAs maternity services evolve and the population of women served also changes, there is a continuing need to effectively document the views of women with recent experience of care. A woman's maternity experience can have a positive or negative effect upon her emotional well-being and health, in the immediate and the long-term, which can also impact the infant and the wider family system. Measuring women's perceptions of maternity services is an important way of monitoring the quality of care provision, as well as providing key indicators to organisations of the services that they are providing. It follows that, without information identifying possible areas in need of improvement, it is not clear what changes should be made to improve the experiences of women during their journey through maternity services from pregnancy to the early weeks at home with a new baby . The objective is to describe the development process and psychometric properties of a measure of women's experience of maternity care covering the three distinctly different phases of maternity - pregnancy, labour and birth, and the early postnatal period.MethodsData from a national survey of women who had recently given birth (n = 504) were used. Exploratory and confirmatory factor analytic methods were employed. The measure was assessed for underlying latent factor structure, as well as for reliability, internal consistency, and validity (predictive, convergent and discriminant).ResultsThe models developed confirmed the use of three separate, but related scales about experience of maternity care during pregnancy, labour and birth and the postnatal period. Data reduction was effective, resulting in a measure with 36 items (12 per scale).ConclusionThe need for a psychometrically robust and qualitatively comprehensive measure of women's experience of maternity care has been addressed in the development and validation of this prototype measure. The whole measure can be used at one time point, or the three separate subscales used as individual measures of experience during particular phases of the maternity journey with identified factor structures in their own right.

Project description:BackgroundIn Australia and internationally, there is concern about the growing proportion of women giving birth by caesarean section. There is evidence of increased risk of placenta accreta and percreta in subsequent pregnancies as well as decreased fertility; and significant resource implications. Randomised controlled trials (RCTs) of continuity of midwifery care have reported reduced caesareans and other interventions in labour, as well as increased maternal satisfaction, with no statistically significant differences in perinatal morbidity or mortality. RCTs conducted in the UK and in Australia have largely measured the effect of teams of care providers (commonly 6-12 midwives) with very few testing caseload (one-to-one) midwifery care. This study aims to determine whether caseload (one-to-one) midwifery care for women at low risk of medical complications decreases the proportion of women delivering by caesarean section compared with women receiving 'standard' care. This paper presents the trial protocol in detail.Methods/designA two-arm RCT design will be used. Women who are identified at low medical risk will be recruited from the antenatal booking clinics of a tertiary women's hospital in Melbourne, Australia. Baseline data will be collected, then women randomised to caseload midwifery or standard low risk care. Women allocated to the caseload intervention will receive antenatal, intrapartum and postpartum care from a designated primary midwife with one or two antenatal visits conducted by a 'back-up' midwife. The midwives will collaborate with obstetricians and other health professionals as necessary. If the woman has an extended labour, or if the primary midwife is unavailable, care will be provided by the back-up midwife. For women allocated to standard care, options include midwifery-led care with varying levels of continuity, junior obstetric care and community based general medical practitioner care. Data will be collected at recruitment (self administered survey) and at 2 and 6 months postpartum by postal survey. Medical/obstetric outcomes will be abstracted from the medical record. The sample size of 2008 was calculated to identify a decrease in caesarean birth from 19 to 14% and detect a range of other significant clinical differences. Comprehensive process and economic evaluations will be conducted.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN012607000073404.

Project description:BackgroundThe study focuses on the perceived nature / technique opposition in pregnancy and delivery emerging from gynaecologist/ midwife/ pregnant woman relationships. We developed a cross-sectional survey to identify, by means of a multidimensional data-driven approach, the main latent concepts structuring the between items correlation correspondent to the different general opinions present in the data set. The obtained results can set the basis to improve patient satisfaction while decreasing healthcare costs.MethodsThe sample is made of 90 pregnant women within 24-48 hours after natural or operative birth, from three maternity units in Italy. Women filled in a questionnaire about their relationship with gynaecologist and midwife during pregnancy and hospital stay for delivery.ResultsParticipation rate approached 100%. The emerging factorial structure gave a proof-of-concept of the hypothesis of 'nature vs. technique' as the main dimension shaping women opinions. The results highlighted the role of midwife as the 'link' between the natural and technical dimension of birth. The quality of welcome and the establishing of an empathic relation between mother and healthcare professional was shown to decrease further request of care in the post-partum period.ConclusionsThe "fault plane" between nature and technique is a very critical zone for litigation. Women are particularly sensitive to the consideration and attention they receive at their admission in the hospital, as well as to the quality of human relationship with midwife. The perceived quality of welcome scaled with a decreased need of additional care and, more in general, with a more faithful attitude towards health professionals. We hypothesize that increasing the quality of welcome can exert an effect on both welfare costs and litigation. This opens the way (through an extension of this pilot study to wider populations) to relevant ameliorative actions on quality of care at practically null cost.

Dataset Information

Efficacy of a midwife-coordinated, individualized, and specialized maternity care intervention (ChroPreg) in addition to standard care in pregnant women with chronic disease: protocol for a parallel randomized controlled trial.

Publications

Efficacy of a midwife-coordinated, individualized, and specialized maternity care intervention (ChroPreg) in addition to standard care in pregnant women with chronic disease: protocol for a parallel randomized controlled trial.

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