Abstract Background Women experiencing pregnancy after stillbirth experience high levels of anxiety, fear and depression. Standard antenatal care may be emotionally unsuitable for many women at this time, and there is a lack of evidence on what interventions or approaches to care might benefit these women. Therapeutic massage may assist women after stillbirth by decreasing anxiety, worry and stress. Objective This paper outlines the objectives, methodology, outcome and assessment measures for the Helping suppOrt individuals Pregnant after Experiencing a Stillbirth (HOPES) feasibility trial which evaluates massage as an adjunct approach to care for pregnant women who have experienced a prior stillbirth. It also outlines data collection timing and considerations for analysing the data. Methods HOPES will use a convergent parallel mixed-methods, single-arm repeated measures trial design in trained massage therapists’ private clinics across Australia. HOPES aims to recruit 75 individuals pregnant after a previous stillbirth. The intervention is massage therapy treatments, and participants will receive up to five massages within a 4-month period at intervals of their choosing. Primary quantitative outcomes are the feasibility and acceptability of the massage intervention. Secondary outcomes include determining the optimal timing of massage therapy delivery and the collection of measures for anxiety, worry, stress and self-management. A thematic analysis of women’s experiences undertaking the intervention will also be conducted. A narrative and joint display approach to integrate mixed-methods data is planned. Discussion The HOPES study will determine the feasibility and preliminary evidence for massage therapy as an intervention to support women who are pregnant after a stillbirth. Trial registration. ClinicalTrials.gov NCT05636553. Registered on December 3, 2022, and the trial is ongoing. 

Swedish massage as an adjunct approach to Help suppOrt individuals Pregnant after Experiencing a prior Stillbirth (HOPES): a convergent parallel mixed-methods single-arm feasibility trial protocol

Key recommendations A combination of mifepristone and a prostaglandin preparation should usually be recommended as the first‐line intervention for induction of labour (Grade B). A single 200 milligram dose of mifepristone is appropriate for this indication, followed by: 24 +0 –24 +6 weeks of gestation – 400 micrograms buccal/sublingual/vaginal/oral of misoprostol every 3 hours; 25 +0 –27 +6 weeks of gestation – 200 micrograms buccal/sublingual/vaginal/oral of misoprostol every 4 hours; from 28 +0 weeks of gestation – 25–50 micrograms vaginal every 4 hours, or 50–100 micrograms oral every 2 hours [Grade C]. There is insufficient evidence available to recommend a specific regimen of misoprostol for use at more than 28 +0 weeks of gestation in women who have had a previous caesarean birth or transmural uterine scar [Grade D]. Women with more than two lower segment caesarean births or atypical scars should be advised that the safety of induction of labour is unknown [Grade D]. Staff should be educated in discussing mode of birth with bereaved parents. Vaginal birth is recommended for most women, but caesarean birth will need to be considered for some [Grade D]. A detailed informed discussion should be undertaken with parents of both physical and psychological aspects of a vaginal birth versus a caesarean birth [Grade C]. Parents should be cared for in an environment that provides adequate safety according to individual clinical circumstance, while meeting their needs to grieve and feel supported in doing so (GPP). Clinical and laboratory tests should be recommended to assess maternal wellbeing (including coagulopathy) and to determine the cause of fetal death, the chance of recurrence and possible means of avoiding future pregnancy complications [Grade D]. Parents should be advised that with full investigation (including postmortem and placental histology) a possible or probable cause can be found in up to three‐quarters of late intrauterine fetal deaths [Grade B]. All parents should be offered cytogenetic testing of their baby, which should be performed after written consent is given (GPP). Parents should be advised that postmortem examination can provide information that can sometimes be crucial to the management of future pregnancy [Grade B]. 

Care of late intrauterine fetal death and stillbirth

This study aimed to provide a systematic overview of existing quantitative research on the effects of psychotherapy interventions given to women with stillbirth on the grief process and depression in the postpartum period and to analyze the results. Four databases (PubMed (MEDLINE), Cochrane, Google Scholar, Web of Science) were searched between January-March 2024. Risk of bias and precision of evidence were assessed with the Cochrane risk of bias tool ROB-2 and ROBIN-1. Ten studies were included. Meta-analysis results showed that psychotherapeutic interventions significantly reduced the grief adaptations of mothers in the mourning process and there was a significant difference in the assessment of grief adaptation. Sub-group analyzes revealed mothers' depression values and stress levels compared to the control groups and there was a significant difference between the groups. Psychotherapeutic interventions given to women positively affect their grief adaptation and reduce stress, anxiety, and depression.PROSPERO ID: CRD42024516195.

The Effect of Psychotherapy Interventions After Stillbirth on the Grief Process and Depression: Systematic Review and Meta-Analysis.

Previous research indicates disparities in the care of bereaved parents and siblings following a stillbirth in the family. The aim of this systematic review was to assess the effects of interventions aimed at reducing psychological distress among parents or siblings in high-income countries after experiencing a stillbirth. The databases CINAHL, Medline, PsycInfo, Cochrane Library, and EMBASE were searched in August 2022. Four intervention studies from the United States (US), the United Kingdom (UK), Finland, and Australia, met the inclusion criteria. The interventions comprised a perinatal grief support team; a perinatal counselling service; a grief support program; and a support package including contacts with peer supporters and health care staff. No studies of interventions for siblings were found. The results could not be synthesised due to disparities in interventions and outcome measures. The risk of bias was assessed as high in all four studies and the certainty for all outcomes was rated as very low. More controlled trials with rigorous methods are needed to evaluate the effect of bereavement support interventions in parents and siblings after stillbirth. Future studies should include a core outcome set to make them more comparable. Most of the studies in this review were assessed to have an overall high risk of bias, mainly due to problems with missing outcome data; thus, future studies could specifically target this problem. 

Support interventions to reduce psychological distress in families experiencing stillbirth in high income countries: A systematic review.

ABSTRACT Background Stillbirth, second‐trimester miscarriage and recurrent miscarriage carry significant consequences for women. We lack sufficient high‐quality evidence of interventions to improve a woman's health and subsequent pregnancy outcomes after discharge to the community. Objective Assess the effectiveness of interventions to improve general health and subsequent pregnancy outcomes for non‐pregnant women who have had a stillbirth, second trimester miscarriage, or recurrent miscarriage. Search Strategy Database searches were undertaken in August 2022 (updated March 2024) and limited to full‐text documents published from 1995. Selection Criteria Interventions delivered after discharge for non‐pregnant women following a pregnancy loss. Data Collection and Analysis Screening was performed independently by two reviewers; narrative synthesis was undertaken. Risk of bias was assessed by RoB‐2, ROBINS‐I or the Mixed Methods Appraisal Tool. Main Results A total of 18 603 abstracts screened; 196 full texts assessed and 15 papers included. The quality of evidence was low, and the primary aim of the review was not met due to limited evidence. All included studies aimed to improve mental health. No studies were identified that aimed to improve the physical health of women or subsequent pregnancy outcomes. Conclusions There is a significant evidence gap regarding how best to care for women who experience pregnancy loss after discharge to the community. There is an urgent need for research to determine which interventions are most effective to improve a woman's short‐ and long‐term health and subsequent pregnancy outcomes following a stillbirth, second‐trimester miscarriage or recurrent miscarriage. Trial Registration PROSPERO Registration: CRD42022360264 

Interventions to Improve Outcomes After Pregnancy Loss: A Systematic Review

A core outcome set could address inconsistent outcome reporting and improve evidence for stillbirth care research, which have been identified as an important research priority.

Interventions, outcomes and outcome measurement instruments in stillbirth care research: A systematic review to inform the development of a core outcome set

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Interventions, outcomes and outcome measurement instruments in stillbirth care research: A systematic review to inform the development of a core outcome set