Childbirth Clinical Trial
Official title:
Reviewing Birth Experience With a Known Midwife: a Feasibility Study
Verified date | October 2022 |
Source | University of Iceland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is a part of a PhD thesis. The study aims to develop a specific midwifery intervention consisting of two components; women writing about the birth experience and reviewing their experience with a known midwife. Women´s birth experience has received research attention worldwide, showing a prevalence of negative birth experience ranging from 5-34%. Considerable knowledge of predictors and impacts of negative birth experience exists, but less is known about effective interventions although women report that reviewing birth experiences is beneficial. Six to eight midwives, providing antenatal care at the high-risk maternity clinic at Landspitali University Hospital, provide the intervention after completing a special training program. Thirty women who had their antenatal care provided at the clinic, after 28 weeks of pregnancy, will be invited to write about their birth experience and review it with the midwife who provided their antenatal care, four to six weeks after birth. The study is based on a mixed method design where quantitative and qualitative data will be collected. Data including traumatic symptoms, birth outcomes, birth experience and experience of the intervention, will be collected from women before the intervention and then six weeks later. The participating midwives´ diaries and focus group interviews will be used to explore their experience of providing the intervention. Descriptive and thematic analysis will be used.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 31, 2022 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Women aged = 18 years old, having their antenatal care provided at the clinic after 28 weeks of pregnancy and planned a vaginal birth. Exclusion Criteria: - Women < 18 years old, referred to the clinic after 28 weeks of pregnancy, not reading Icelandic or planned elective caesarean section. |
Country | Name | City | State |
---|---|---|---|
Iceland | Valgerdur Lisa Sigurdardottir | Reykjavik |
Lead Sponsor | Collaborator |
---|---|
University of Iceland |
Iceland,
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in traumatic symptoms | The Icelandic version of the Post-traumatic stress disorder Checklist for DSM-5 (PCL-5) will be used. It is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of post-traumatic stress disorder. The self-reporting rating scale is 0-4, from ´Not at all,´ ´A little bit,´ Moderately,´ ´Quite a bit,´ to ´Extremely´. A total symptom severity score ranges from 0-80, with higher scores indicating more post-traumatic symptoms. It can also be interpreted in clusters of avoidance (5 items), avoidance (2 items), negative alterations in cognitions and mood (7 items) and alterations in arousal and reactivity (6 items). | 4-6 weeks and 10-12 weeks post-partum | |
Primary | Traumatic events in lifetime | Traumatic events in lifetime are measured with the Life Events Checklist for DSM-5 (LEC-5), translated in Icelandic. The LEC-5 is a self-report measure to screen for potentially traumatic events in a respondent's lifetime. It assesses exposure to 16 events known to potentially result in traumatic symptoms and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items. Respondents indicate varying levels of exposure to each type of potentially traumatic event included on a 6-point nominal scale: ´happened to me´, ´witnessed it´, ´learned about it´, ´part of my job´, ´not sure´, ´doesn't apply´. | 4-6 weeks | |
Primary | Change in the perception of birth experience | The birth experience will be measured by responses from the question ´How did you experience your birth?´ with the response options ranging from 1 (very positive) to 5 (very negative) | 4-6 weeks and 10-12 weeks post-partum | |
Primary | Change in the overall perception of birth experience | The birth experience will be measured by responses from the question ´How was your overall perception of your birth?´ with the response options ranging from 1 (very difficult) to 5 (very easy). | 4-6 weeks and 10-12 weeks post-partum | |
Primary | Self-reported birth outcomes: onset of labour, birth mode, experience of the birth duration, admission to neonatal intensive care unit, perineal outcomes and breastfeeding | Information about birth outcomes will be obtained by questions about the onset of labour, birth mode, experience of the birth duration, admission to neonatal intensive care unit and perineal outcomes. Breastfeeding will be addressed by the question ´How did you perceive the breastfeeding was going?´ with options on a five-point Likert scale 1 (very well) to 5 (very bad) or ´I did not breastfeed'. | 4-6 weeks post-partum | |
Primary | Change in self-reported well-being during recent birth | Information about well-being during the recent birth will be obtained by a list of statements f.ex. ´I felt secure/strong/in control´ with response options ranging from 1 (very much agree) to 5 (very much disagree) | 4-6 weeks and 10-12 weeks post-partum | |
Primary | Self-reported health-related issues before and during pregnancy | Information about health-related issues will be obtained by a list of common health problems known to increase risk during the childbirth period. The list includes statements of physical or mental health issues f.ex. 'I have a history of or had diabetes/hypertension/mental disorders... before pregnancy', with the option ´other´ at the end (free text). Health during the recent pregnancy will be obtained by a list of common risk factors during pregnancy f.ex. ´I was diagnosed with diabetes/hypertension/pre-eclampsia/... during pregnancy´, with the option ´other´ (free text) at the end. | 4-6 weeks post-partum | |
Primary | Self-reported reproductive history | Information about reproductive history will be obtained by a list of statements about parity and history of premature birth, stillbirth, placenta abruptio, emergency cesarean or fear of birth. | 4-6 weeks post-partum | |
Primary | Perception of writing about and reviewing birth experience with a known midwife | Women´s perception of reviewing the birth experience will be obtained by questions about if the intervention; was useful, met their expectations, they got answers to their questions, if they felt they were listened to and could express themselves. The responses were on a five-point Likert scale from 1 (very much agree) to 5 (very much disagree). They will also be asked of their views about the conversation about reviewing the birth experience, when, where and who should provide it. Space for free text reports about the interview will be at the end of the questionnaire. | 10-12 weeks post-partum | |
Primary | Socio-demographic factors: age, education, marital status, | The age will be measured by year of birth. The educational status and marital status will be measured by lists of four categories. | 4-6 weeks post-partum |
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