ChildbirthNCT03883529
Reviewing Birth Experience With a Known Midwife
A study testing Writing about and reviewing birth experience in people with Childbirth, run by University of Iceland at 1 site in Iceland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Childbirth
- What is being tested?
- Writing about and reviewing birth experience
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIceland
- Study dates
- 10 Nov 2018to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged ≥ 18 years old, having their antenatal care provided at the clinic after 28 weeks of pregnancy and planned a vaginal birth.
Who cannot join
- Women < 18 years old, referred to the clinic after 28 weeks of pregnancy, not reading Icelandic or planned elective caesarean section.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reviewing Birth Experience With a Known Midwife: a Feasibility Study
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.
Read the detailed description
The purpose of the study is to develop and explore the feasibility and acceptability of an intervention, involving writing about and reviewing birth experience with a known midwife from antenatal care.
Studies in developed countries indicate that between 5-16.5% of women perceive their births to be negative. The perception of birth experience seems to be consistent over time, suggesting that time alone does not have a healing effect. Adverse consequences of negative birth experience can be profound and have an impact on different aspects of woman´s life. Among well-known consequences are development of fear of childbirth, a tendency to delay pregnancy and longer interval between children, an increase in request for elective caesarean section without health indications and mental health problems like depression, anxiety and post-traumatic stress disorder (PTSD). Around 1-6% of women develop PTSD in response to pregnancy, birth and post-partum events. Negative birth experience may have long-term and negative consequences on the women´s self-identity and relationships with their infants and partners. This is of concern as there is a growing body of literature showing negative consequences of maternal mental distress on the mother-infant bonding and attachment process, and relationships with partner. Improvement in bonding could take as long as one to five years - which needs attention because a delay in bonding can have detrimental effects on the child's long-term development.
Risk factors for a negative birth experience are multifaceted and associations have been found between negative birth experience and instrumental or caesarean births, intrapartum complications, maternal complications or hospitalisation in pregnancy and prolonged labour. Furthermore, fear of childbirth, negative thoughts about the upcoming birth, prior negative birth experience, feelings of not being in control, and powerlessness during birth have been associated with negative birth experiences as well as history of mental health problems. Furthermore, perceived lack of professional support during pregnancy or birth has been associated with negative experience of birth.
Evidence for useful methods to assist women with negative childbirth experience is limited. Interventions aimed to assist women with negative birth experience have been explored but the effectiveness remains inconsistent, with five comparative studies showing improvements on psychological measures while six of them did not. In recent studies a method of writing about the experience was explored with promising results, where one of them showed a reduction in depressive and traumatic symptoms and the other one showed emotional benefits like clarifying thoughts and feelings of empowerment.
It is worth considering that in many of the above comparative studies, the need to review the birth experience was based on the view of health professionals. Also, the interviews were limited to women who experienced an operative birth or unexpected events during birth but none of these were effective in psychological improvements. Likewise, the time between the negative birth experience until the intervention was provided ranged from the first week after birth up to seven years after birth. Similarly, the structure, content and quantity of interview interventions varied. Each study´s design and outcome measures used, varied significantly making it difficult to determine which components of the interventions women considered most effective. Despite failure in these studies to show significant changes in psychological measures, women reported that it was helpful to participate in the intervention.
The results from authors´ recent study in Iceland provide important insights into women´s views about the process of reviewing negative birth experience and reconciling difficult emotions, at a special midwifery clinic Ljáðu mér eyra (LME) at Landspítali. The women prefer their negative birth experiences to be detected by professionals and consequently have opportunity to review their birth experience in a tailored conversation on their terms. Many of them revealed preferences of talking to a known midwife who had provided care during pregnancy or birth, suggesting a request for some form of continuity of care. Reviewing the birth experience provided an opportunity for many women to relieve the burden of difficult emotions, enhance well-being and gain strength to move on with their lives.
The ideological background of the study is affected by the international ideology of midwifery and models of care. According to the International Confederation of midwives' philosophy and model of midwifery care (2014), birth is not only … a normal and physiological process… but also … a profound experience, which carries significant meaning to the woman and her family. Midwifery care combines art and science and is holistic in nature, grounded in an understanding of the social, emotional, cultural, spiritual, psychological experiences of women and based upon the best available evidence. Furthermore, in International Confederation of midwives' code of ethics (2014) is stated that midwives should … respond to the psychological, physical, emotional and spiritual needs of women…,requiring midwives to react to women´s needs following childbirth from a holistic perspective. This philosophy of care is extended in Renfrew´s et. al. framework for childbirth care and a midwifery model of woman-centred childbirth care, developed in Swedish and Icelandic settings. Good quality midwifery care includes continuity of care, information, communication and understanding of women's needs. According to the above, interventions need to be tailored to women's circumstances and needs and provided in partnership with them.
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. Six to eight midwives will provide the intervention after completing a 12-hour training program. The study is based on a mixed method design where quantitative and qualitative data will be collected. Data including traumatic symptoms, traumatic life events, birth outcomes and birth experience will be collected from women before the intervention. Four to six weeks after the intervention, data about birth experience, traumatic symptoms and experience of the intervention will be collected. 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.
- Conditions
- Childbirth
- Being tested
- Writing about and reviewing birth experience
- Keywords
- Birth experience, Midwifery, Feasibilty, Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Writing about and reviewing birth experienceOther
Writing about and reviewing birth experience with a known midwife from antenatal care about 6 weeks post-partum.
| Study group | Role | What they receive |
|---|---|---|
| Women reviewing birth experience | Experimental | Women who had their antenatal care provided at a high-risk antenatal clinic, will be offered to write about and review their birth experience about 6 weeks post-partum with a known midwife from antenatal care. Receives: Other: Writing about and reviewing birth experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4-6 weeks and 10-12 weeks post-partum
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´.
Measured: 4-6 weeks
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)
Measured: 4-6 weeks and 10-12 weeks post-partum
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).
Measured: 4-6 weeks and 10-12 weeks post-partum
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'.
Measured: 4-6 weeks post-partum
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)
Measured: 4-6 weeks and 10-12 weeks post-partum
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.
Measured: 4-6 weeks post-partum
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.
Measured: 4-6 weeks post-partum
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.
Measured: 10-12 weeks post-partum
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.
Measured: 4-6 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start10 Nov 2018
- Primary completion30 Jun 2019
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a pilot feasibility study, exploring a new type of intervention after birth, for women who had their antenatal care provided at a high-risk maternity clinic. The intervention involves women writing about and reviewing their birth experience, six to eight weeks after birth, with the midwife who provided antenatal care.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helga Gottfredsdottir, Study director, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883529
- Sponsor's protocol ID
- UIceland
- Status last verified
- Oct 2022
- First submitted
- 21 Feb 2019
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sigurdardottir VL, Gamble J, Gudmundsdottir B, Kristjansdottir H, Sveinsdottir H, Gottfredsdottir H. The predictive role of support in the birth experience: A longitudinal cohort study. Women Birth. 2017 Dec;30(6):450-459. doi: 10.1016/j.wombi.2017.04.003. Epub 2017 May 3.
PubMed 28478933Sigurethardottir VL, Gamble J, Guethmundsdottir B, Sveinsdottir H, Gottfreethsdottir H. Processing birth experiences: A content analysis of women's preferences. Midwifery. 2019 Feb;69:29-38. doi: 10.1016/j.midw.2018.10.016. Epub 2018 Oct 27.
PubMed 30396158Rijnders M, Baston H, Schonbeck Y, van der Pal K, Prins M, Green J, Buitendijk S. Perinatal factors related to negative or positive recall of birth experience in women 3 years postpartum in the Netherlands. Birth. 2008 Jun;35(2):107-16. doi: 10.1111/j.1523-536X.2008.00223.x.
PubMed 18507581Waldenstrom U, Hildingsson I, Rubertsson C, Radestad I. A negative birth experience: prevalence and risk factors in a national sample. Birth. 2004 Mar;31(1):17-27. doi: 10.1111/j.0730-7659.2004.0270.x.
PubMed 15015989Ayers S, Eagle A, Waring H. The effects of childbirth-related post-traumatic stress disorder on women and their relationships: a qualitative study. Psychol Health Med. 2006 Nov;11(4):389-98. doi: 10.1080/13548500600708409.
PubMed 17129916Fenech G, Thomson G. Tormented by ghosts from their past': a meta-synthesis to explore the psychosocial implications of a traumatic birth on maternal well-being. Midwifery. 2014 Feb;30(2):185-93. doi: 10.1016/j.midw.2013.12.004. Epub 2013 Dec 13.
PubMed 24411664Waldenstrom U. Why do some women change their opinion about childbirth over time? Birth. 2004 Jun;31(2):102-7. doi: 10.1111/j.0730-7659.2004.00287.x.
PubMed 15153129Baxter JD, McCourt C, Jarrett PM. What is current practice in offering debriefing services to post partum women and what are the perceptions of women in accessing these services: a critical review of the literature. Midwifery. 2014 Feb;30(2):194-219. doi: 10.1016/j.midw.2013.12.013. Epub 2013 Dec 27.
PubMed 24491690Borg Cunen N, McNeill J, Murray K. A systematic review of midwife-led interventions to address post partum post-traumatic stress. Midwifery. 2014 Feb;30(2):170-84. doi: 10.1016/j.midw.2013.09.003. Epub 2013 Sep 21.
PubMed 24238899Gamble J, Creedy D, Moyle W, Webster J, McAllister M, Dickson P. Effectiveness of a counseling intervention after a traumatic childbirth: a randomized controlled trial. Birth. 2005 Mar;32(1):11-9. doi: 10.1111/j.0730-7659.2005.00340.x.
PubMed 15725200Lavender T, Walkinshaw SA. Can midwives reduce postpartum psychological morbidity? A randomized trial. Birth. 1998 Dec;25(4):215-9. doi: 10.1046/j.1523-536x.1998.00215.x.
PubMed 9892887Ryding EL, Wiren E, Johansson G, Ceder B, Dahlstrom AM. Group counseling for mothers after emergency cesarean section: a randomized controlled trial of intervention. Birth. 2004 Dec;31(4):247-53. doi: 10.1111/j.0730-7659.2004.00316.x.
PubMed 15566336Meades R, Pond C, Ayers S, Warren F. Postnatal debriefing: have we thrown the baby out with the bath water? Behav Res Ther. 2011 May;49(5):367-72. doi: 10.1016/j.brat.2011.03.002. Epub 2011 Mar 12.
PubMed 21457944Blasio PD, Camisasca E, Caravita SC, Ionio C, Milani L, Valtolina GG. THE EFFECTS OF EXPRESSIVE WRITING ON POSTPARTUM DEPRESSION AND POSTTRAUMATIC STRESS SYMPTOMS. Psychol Rep. 2015 Dec;117(3):856-82. doi: 10.2466/02.13.PR0.117c29z3. Epub 2015 Nov 23.
PubMed 26595300Blainey SH, Slade P. Exploring the process of writing about and sharing traumatic birth experiences online. Br J Health Psychol. 2015 May;20(2):243-60. doi: 10.1111/bjhp.12093. Epub 2014 Mar 12.
PubMed 24620933
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reviewing Birth Experience With a Known Midwife: a Feasibility Study
- ClinicalTrials.gov ID
- NCT03883529
- Acronym / sponsor ID
- UIceland
- Conditions
- Childbirth
- Keywords
- Birth experience, Midwifery, Feasibilty, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the study is to develop and explore the feasibility and acceptability of an intervention, involving writing about and reviewing birth experience with a known midwife from antenatal care.
Studies in developed countries indicate that between 5-16.5% of women perceive their births to be negative. The perception of birth experience seems to be consistent over time, suggesting that time alone does not have a healing effect. Adverse consequences of negative birth experience can be profound and have an impact on different aspects of woman´s life. Among well-known consequences are development of fear of childbirth, a tendency to delay pregnancy and longer interval between children, an increase in request for elective caesarean section without health indications and mental health problems like depression, anxiety and post-traumatic stress disorder (PTSD). Around 1-6% of women develop PTSD in response to pregnancy, birth and post-partum events. Negative birth experience may have long-term and negative consequences on the women´s self-identity and relationships with their infants and partners. This is of concern as there is a growing body of literature showing negative consequences of maternal mental distress on the mother-infant bonding and attachment process, and relationships with partner. Improvement in bonding could take as long as one to five years - which needs attention because a delay in bonding can have detrimental effects on the child's long-term development.
Risk factors for a negative birth experience are multifaceted and associations have been found between negative birth experience and instrumental or caesarean births, intrapartum complications, maternal complications or hospitalisation in pregnancy and prolonged labour. Furthermore, fear of childbirth, negative thoughts about the upcoming birth, prior negative birth experience, feelings of not being in control, and powerlessness during birth have been associated with negative birth experiences as well as history of mental health problems. Furthermore, perceived lack of professional support during pregnancy or birth has been associated with negative experience of birth.
Evidence for useful methods to assist women with negative childbirth experience is limited. Interventions aimed to assist women with negative birth experience have been explored but the effectiveness remains inconsistent, with five comparative studies showing improvements on psychological measures while six of them did not. In recent studies a method of writing about the experience was explored with promising results, where one of them showed a reduction in depressive and traumatic symptoms and the other one showed emotional benefits like clarifying thoughts and feelings of empowerment.
It is worth considering that in many of the above comparative studies, the need to review the birth experience was based on the view of health professionals. Also, the interviews were limited to women who experienced an operative birth or unexpected events during birth but none of these were effective in psychological improvements. Likewise, the time between the negative birth experience until the intervention was provided ranged from the first week after birth up to seven years after birth. Similarly, the structure, content and quantity of interview interventions varied. Each study´s design and outcome measures used, varied significantly making it difficult to determine which components of the interventions women considered most effective. Despite failure in these studies to show significant changes in psychological measures, women reported that it was helpful to participate in the intervention.
The results from authors´ recent study in Iceland provide important insights into women´s views about the process of reviewing negative birth experience and reconciling difficult emotions, at a special midwifery clinic Ljáðu mér eyra (LME) at Landspítali. The women prefer their negative birth experiences to be detected by professionals and consequently have opportunity to review their birth experience in a tailored conversation on their terms. Many of them revealed preferences of talking to a known midwife who had provided care during pregnancy or birth, suggesting a request for some form of continuity of care. Reviewing the birth experience provided an opportunity for many women to relieve the burden of difficult emotions, enhance well-being and gain strength to move on with their lives.
The ideological background of the study is affected by the international ideology of midwifery and models of care. According to the International Confederation of midwives' philosophy and model of midwifery care (2014), birth is not only … a normal and physiological process… but also … a profound experience, which carries significant meaning to the woman and her family. Midwifery care combines art and science and is holistic in nature, grounded in an understanding of the social, emotional, cultural, spiritual, psychological experiences of women and based upon the best available evidence. Furthermore, in International Confederation of midwives' code of ethics (2014) is stated that midwives should … respond to the psychological, physical, emotional and spiritual needs of women…,requiring midwives to react to women´s needs following childbirth from a holistic perspective. This philosophy of care is extended in Renfrew´s et. al. framework for childbirth care and a midwifery model of woman-centred childbirth care, developed in Swedish and Icelandic settings. Good quality midwifery care includes continuity of care, information, communication and understanding of women's needs. According to the above, interventions need to be tailored to women's circumstances and needs and provided in partnership with them.
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. Six to eight midwives will provide the intervention after completing a 12-hour training program. The study is based on a mixed method design where quantitative and qualitative data will be collected. Data including traumatic symptoms, traumatic life events, birth outcomes and birth experience will be collected from women before the intervention. Four to six weeks after the intervention, data about birth experience, traumatic symptoms and experience of the intervention will be collected. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a pilot feasibility study, exploring a new type of intervention after birth, for women who had their antenatal care provided at a high-risk maternity clinic. The intervention involves women writing about and reviewing their birth experience, six to eight weeks after birth, with the midwife who provided antenatal care.
| Arm | Type | Receives |
|---|---|---|
| Women reviewing birth experience | Experimental | Other: Writing about and reviewing birth experienceWomen who had their antenatal care provided at a high-risk antenatal clinic, will be offered to write about and review their birth experience about 6 weeks post-partum with a known midwife from antenatal care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women aged ≥ 18 years old, having their antenatal care provided at the clinic after 28 weeks of pregnancy and planned a vaginal birth.
Key exclusion criteria (1 listed)
- Women < 18 years old, referred to the clinic after 28 weeks of pregnancy, not reading Icelandic or planned elective caesarean section.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Writing about and reviewing birth experienceWriting about and reviewing birth experience with a known midwife from antenatal care about 6 weeks post-partum. | Other | Women reviewing birth experience |
Primary outcome
Change in traumatic symptoms
Time frame: 4-6 weeks and 10-12 weeks post-partum
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).
Traumatic events in lifetime
Time frame: 4-6 weeks
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´.
Change in the perception of birth experience
Time frame: 4-6 weeks and 10-12 weeks post-partum
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)
Change in the overall perception of birth experience
Time frame: 4-6 weeks and 10-12 weeks post-partum
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).
Self-reported birth outcomes: onset of labour, birth mode, experience of the birth duration, admission to neonatal intensive care unit, perineal outcomes and breastfeeding
Time frame: 4-6 weeks post-partum
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'.
Change in self-reported well-being during recent birth
Time frame: 4-6 weeks and 10-12 weeks post-partum
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)
Self-reported health-related issues before and during pregnancy
Time frame: 4-6 weeks post-partum
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.
Self-reported reproductive history
Time frame: 4-6 weeks post-partum
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.
Perception of writing about and reviewing birth experience with a known midwife
Time frame: 10-12 weeks post-partum
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.
Socio-demographic factors: age, education, marital status,
Time frame: 4-6 weeks post-partum
The age will be measured by year of birth. The educational status and marital status will be measured by lists of four categories.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Background: PubMed 28478933Sigurdardottir VL, Gamble J, Gudmundsdottir B, Kristjansdottir H, Sveinsdottir H, Gottfredsdottir H. The predictive role of support in the birth experience: A longitudinal cohort study. Women Birth. 2017 Dec;30(6):450-459. doi: 10.1016/j.wombi.2017.04.003. Epub 2017 May 3.
- Background: PubMed 30396158Sigurethardottir VL, Gamble J, Guethmundsdottir B, Sveinsdottir H, Gottfreethsdottir H. Processing birth experiences: A content analysis of women's preferences. Midwifery. 2019 Feb;69:29-38. doi: 10.1016/j.midw.2018.10.016. Epub 2018 Oct 27.
- Background: PubMed 18507581Rijnders M, Baston H, Schonbeck Y, van der Pal K, Prins M, Green J, Buitendijk S. Perinatal factors related to negative or positive recall of birth experience in women 3 years postpartum in the Netherlands. Birth. 2008 Jun;35(2):107-16. doi: 10.1111/j.1523-536X.2008.00223.x.
- Background: PubMed 15015989Waldenstrom U, Hildingsson I, Rubertsson C, Radestad I. A negative birth experience: prevalence and risk factors in a national sample. Birth. 2004 Mar;31(1):17-27. doi: 10.1111/j.0730-7659.2004.0270.x.
- Background: PubMed 17129916Ayers S, Eagle A, Waring H. The effects of childbirth-related post-traumatic stress disorder on women and their relationships: a qualitative study. Psychol Health Med. 2006 Nov;11(4):389-98. doi: 10.1080/13548500600708409.
- Background: PubMed 24411664Fenech G, Thomson G. Tormented by ghosts from their past': a meta-synthesis to explore the psychosocial implications of a traumatic birth on maternal well-being. Midwifery. 2014 Feb;30(2):185-93. doi: 10.1016/j.midw.2013.12.004. Epub 2013 Dec 13.
- Background: PubMed 15153129Waldenstrom U. Why do some women change their opinion about childbirth over time? Birth. 2004 Jun;31(2):102-7. doi: 10.1111/j.0730-7659.2004.00287.x.
- Background: PubMed 24491690Baxter JD, McCourt C, Jarrett PM. What is current practice in offering debriefing services to post partum women and what are the perceptions of women in accessing these services: a critical review of the literature. Midwifery. 2014 Feb;30(2):194-219. doi: 10.1016/j.midw.2013.12.013. Epub 2013 Dec 27.
- Background: PubMed 24238899Borg Cunen N, McNeill J, Murray K. A systematic review of midwife-led interventions to address post partum post-traumatic stress. Midwifery. 2014 Feb;30(2):170-84. doi: 10.1016/j.midw.2013.09.003. Epub 2013 Sep 21.
- Background: PubMed 15725200Gamble J, Creedy D, Moyle W, Webster J, McAllister M, Dickson P. Effectiveness of a counseling intervention after a traumatic childbirth: a randomized controlled trial. Birth. 2005 Mar;32(1):11-9. doi: 10.1111/j.0730-7659.2005.00340.x.
- Background: PubMed 9892887Lavender T, Walkinshaw SA. Can midwives reduce postpartum psychological morbidity? A randomized trial. Birth. 1998 Dec;25(4):215-9. doi: 10.1046/j.1523-536x.1998.00215.x.
- Background: PubMed 15566336Ryding EL, Wiren E, Johansson G, Ceder B, Dahlstrom AM. Group counseling for mothers after emergency cesarean section: a randomized controlled trial of intervention. Birth. 2004 Dec;31(4):247-53. doi: 10.1111/j.0730-7659.2004.00316.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helga Gottfredsdottir study director
University of Iceland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Writing about and reviewing birth experience in people with Childbirth, run by University of Iceland at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in traumatic symptoms (time frame: 4-6 weeks and 10-12 weeks post-partum). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03883529, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.