SummaryBackgroundPost-partum haemorrhage is the leading cause of maternal death worldwide. Early administration of tranexamic acid reduces deaths due to bleeding in trauma patients. We aimed to assess the effects of early administration of tranexamic acid on death, hysterectomy, and other relevant outcomes in women with post-partum haemorrhage.MethodsIn this randomised, double-blind, placebo-controlled trial, we recruited women aged 16 years and older with a clinical diagnosis of post-partum haemorrhage after a vaginal birth or caesarean section from 193 hospitals in 21 countries. We randomly assigned women to receive either 1 g intravenous tranexamic acid or matching placebo in addition to usual care. If bleeding continued after 30 min, or stopped and restarted within 24 h of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given. Patients were assigned by selection of a numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Participants, care givers, and those assessing outcomes were masked to allocation. We originally planned to enrol 15 000 women with a composite primary endpoint of death from all-causes or hysterectomy within 42 days of giving birth. However, during the trial it became apparent that the decision to conduct a hysterectomy was often made at the same time as randomisation. Although tranexamic acid could influence the risk of death in these cases, it could not affect the risk of hysterectomy. We therefore increased the sample size from 15 000 to 20 000 women in order to estimate the effect of tranexamic acid on the risk of death from post-partum haemorrhage. All analyses were done on an intention-to-treat basis. This trial is registered with ISRCTN76912190 (Dec 8, 2008); ClinicalTrials.gov, number NCT00872469; and PACTR201007000192283.FindingsBetween March, 2010, and April, 2016, 20 060 women were enrolled and randomly assigned to receive tranexamic acid (n=10 051) or placebo (n=10 009), of whom 10 036 and 9985, respectively, were included in the analysis. Death due to bleeding was significantly reduced in women given tranexamic acid (155 [1·5%] of 10 036 patients vs 191 [1·9%] of 9985 in the placebo group, risk ratio [RR] 0·81, 95% CI 0·65–1·00; p=0·045), especially in women given treatment within 3 h of giving birth (89 [1·2%] in the tranexamic acid group vs 127 [1·7%] in the placebo group, RR 0·69, 95% CI 0·52–0·91; p=0·008). All other causes of death did not differ significantly by group. Hysterectomy was not reduced with tranexamic acid (358 [3·6%] patients in the tranexamic acid group vs 351 [3·5%] in the placebo group, RR 1·02, 95% CI 0·88–1·07; p=0·84). The composite primary endpoint of death from all causes or hysterectomy was not reduced with tranexamic acid (534 [5·3%] deaths or hysterectomies in the tranexamic acid group vs 546 [5·5%] in the placebo group, RR 0·97, 95% CI 0·87-1·09; p=0·65). Adverse events (including thromboembolic events) did not differ significantly in the tranexamic acid versus ...
BackgroundFear of childbirth (FOC) can have a negative impact on a woman’s psychological wellbeing during pregnancy and her experience of birth. It has also been associated with adverse obstetric outcomes and postpartum mental health difficulties. However the FOC construct is itself poorly defined. This study aimed to systematically identify the key elements of FOC as reported by women themselves.MethodsSemi-structured interviews with pregnant women (n = 10) who reported to be fearful of childbirth and telephone interviews with consultant midwives (n = 13) who regularly work with women who are fearful of childbirth were conducted. Interviews were analysed using thematic analysis for each group independently to provide two sources of information. Findings were reviewed in conjunction with a third source, a recently published meta-synthesis of existing literature of women’s own accounts of FOC. The key elements of FOC were determined via presence in two out of the three sources at least one of which was from women themselves, i.e. the reports of the women interviewed or the meta-synthesis.ResultsSeven themes were identified by the women and the consultant midwives: Fear of not knowing and not being able to plan for the unpredictable, Fear of harm or stress to the baby, Fear of inability to cope with the pain, Fear of harm to self in labour and postnatally, Fear of being ‘done to’, Fear of not having a voice in decision making and Fear of being abandoned and alone. One further theme was generated by the women and supported by the reports included the meta-synthesis: Fear about my body’s ability to give birth. Two further themes were generated by the consultant midwives and were present also in the meta-synthesis: Fear of internal loss of control and Terrified of birth and not knowing why.ConclusionsTen key elements in women’s FOC were identified. These can now be used to inform development of measurement tools with verified content validity to identify women experiencing FOC, to support timely access to support during pregnancy.Electronic supplementary materialThe online version of this article (10.1186/s12884-019-2241-7) contains supplementary material, which is available to authorized users.
ObjectiveThe World Maternal Antifibrinolytic (WOMAN) Trial was the first in the UK to use the option of waiver of informed consent at the time of an obstetric emergency. This qualitative study aimed to investigate participants’ views of the acceptability of the recruitment methods used.DesignQualitative study using in‐depth interviews with women who did and did not give consent at the time of their recruitment to the WOMAN Trial.SettingHighest UK recruitment site for the WOMAN Trial (129/569). Interviews were conducted in participants’ homes.PopulationAbout 40 of the 129 women who were recruited to the WOMAN Trial at one UK site were invited to take part, 15 women were interviewed.MethodsQualitative, interview study.Main outcome measuresFacilitators and barriers to successful recruitment during obstetric emergencies. Guidance for future researchers.ResultsFindings revealed that what is important is not so much the consent process used or a signature on a form, but the way in which consent is obtained. Clinicians who successfully negotiate consent to research during childbirth emergencies engage in a ‘humane choreography’ of words and actions. This emphasises the importance of prompt decision‐making and treatment, while respecting the woman's personal situation and experience.ConclusionsOur findings do not support a single pathway to consent in the context of an obstetric emergency. Women understand that consent to research in an emergency is complex. Clinicians’ skills in considering the clinical, ethical, and emotional aspects within the context of the clinical emergency can hamper or promote women's satisfaction.Tweetable abstractStudy reports on women's views of consent to research in an obstetric emergency.Plain Language SummaryWhy and how was the study carried out?We undertook this study to find out what women thought about being included in a research study called the WOMAN Trial at the time they were being treated for heavy bleeding after giving birth. Some women had been asked if they wanted to be a part of the research at the time they were bleeding. Others were asked later, after they had recovered. We conducted interviews with 15 women who had been involved and asked what they thought about the way they had been asked, their preferences and ideas for improvements in future similar studiesWhat were the main findings?Women understood how difficult it was for their doctors and midwives to ask them about the research study. They were pleased to have been included in the research and were mostly happy with the way they gave consent. Women's views were similar whether they were asked about the research at the time of the bleeding or after they had recovered. The most important thing was that doctors and midwives carefully thought about the situation the woman found herself in and how this might make her feel, so they could tailor their approach accordingly.What are the limitations of the work?This study only involved women from one hospital. The WOMAN Trial included women from many areas of the UK and other ...
Background Fear of childbirth is related to but not synonymous with general anxiety, and represents a superior predictor for maternal and infant outcomes. There is a need to improve the identification and provision of support for women experiencing high fear of childbirth. However it is uncertain as to whether existing measurement tools have appropriate content validity (i.e. cover the relevant domains within the construct), practical utility, and whether they are acceptable for use with a UK population. This study aimed to (1) identify the utility and acceptability of existing measures of fear of childbirth (FOC) with a small UK sample and (2) map the content of existing measures to the key concepts of fear of childbirth established by previous research. Methods Ten pregnant women; five with high and five with low fear of childbirth participated in a cognitive interview covering four most commonly used measures of fear of childbirth: 1. The Wijma Delivery Expectancy Questionnaire (WDEQ A), 2. The Oxford Worries about Labour Scale (OWLS), 3. The Slade-Pais Expectations of Childbirth Scale – fear subscale (SPECS) and 4. The Fear of Birth scale (FOBS). Each measure was also reviewed by participants for ease and clarity of understanding and acceptability. The measures were then reviewed against the key domains identified in the fear of childbirth literature to ascertain the adequacy of content validity of each measure. Interviews were analysed using thematic analysis for each scale item. Results All measures except the FOBS, included items that either women did not understand or, if where there was understanding the meanings were inconsistent across women. All measures demonstrated limited acceptability and content validity for the specific construct of FOC. Therefore, none of the measurement tools currently used within the UK met criteria for understanding, acceptability and content validity for measurement of FOC. Conclusions Findings emphasise a need to develop a specific fear of childbirth tool with good clarity which demonstrates appropriate content validity, and that is acceptable in presentation and length for pregnant women in a UK population.
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