An observational study in Fear of Childbirth and Anxiety, sponsored by Mid Sweden University. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-27.
Sponsored by Mid Sweden University · Observational
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This is a study of childbirth related anxiety, fear or worry, in which we follow women from mid pregnancy until about 8 months postpartum. Our overall aim is to enhance our understanding of psychological factors contributing to childbirth related fear or worry. Specifically, we wish to investigate
Women in mid-pregnancy will be recruited at routine check-ups with midwifes working in antenatal health care units in two Swedish regions. After consenting to participate, they will be answering a questionnaire with sociodemographic and obstetric background data, measures of childbirth related fear and anxiety, and measures of psychological variables with a potential relation to childbirth related anxiety. 6-10 months after giving birth they will be contacted again with a postpartum follow-up questionnaire asking questions about the experience of giving birth, postpartum levels of childbirth related fear or anxiety, and thoughts about possible future childbirths. They will also be asked if willing to let the research team include information from their obstetric medical chart (e.g. birth mode and birth interventions, use of analgesia, and complications for the mother and baby) in statistical analyses.
Aim and main research questions:
The overall aim with this study investigate psychological factors contributing to childbirth related fear or worry. Specifically, we wish to investigate
Procedure:
Pregnant women will be recruited by midwives working in antenatal health care units in two Swedish regions; Jämtland/Härjedalen and Örebro County. Recruitment is planned to take place during the first visit following the routine ultrasound examination (normally provided in gestational week 16-20). Women found not eligible will be counted by each antenatal midwife and reported to the project group without any personal identification. Before invited to participate, eligible women will be given oral and written information about the study. Any questions might be asked the midwife directly or via telephone or e-mail to the members of the research group. If accepting participation, each woman will give her written consent. The woman will then receive the first questionnaire. The questionnaire is coded with a unique code for each participant, and does not include any personal identification. It is returned to the research group in a pre-paid envelope. The consent form, also including the unique code of each participant, contact information and personal identification number, is collected by the midwife and later sent to the research group.
In phase two of the study, data will be gathered from two different sources - (a) from the medical birth records of the particular birth, and (b) via a postpartum follow-up questionnaire. These data will be gathered 6-10 months after the planned date of the birth. All women who have returned the first questionnaire and whose address can be confirmed will be contacted by mail and invited to participate in phase two. Letters will be sent, including information about phase two of the project, a postpartum follow-up questionnaire, and a consent form in which the woman can give her written consent for the research team to extract data from the medical birth record. The women are thus free to choose their participation in the two parts of phase 2 separately. The follow-up questionnaire and consent form will returned to the research group by mail, in a pre-paid envelope.
Extraction of medical data: Once consent has been received, obstetric data will be extracted from the medical chart, with help from a midwife at each hospital. The data will be anonymized before leaving the hospital, erasing all personal data such as name and personal identification number, coding the obstetric set of data with the unique participant code number of each woman.
Data and measurements:
The first questionnaire, in mid-pregnancy includes the following sections and scales:
The postpartum follow-up questionnaire includes:
Medical birth data that will be extracted:
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 499 is above the median of 168 across 978 observational studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Mid Sweden University is the lead sponsor of 2 studies on the registry; none are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
A general sample of pregnant Swedish women, recruted at antenatal health care units within primary care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Fear of Birth Scale
Two item VAS-scale assessing worry and fear relating to childbirth. The instrument will be used both as a continuous measure of level of fear, and with a cut point of ≥ 60 indicating fear of birth (\< 60 = no fear of birth)
Time frame: Baseline (around gestational week 20-25) and 6-12 months after expected delivery
Wijma Delivery Expectancy/Experience Questionnaire
33 item 6 point Likert scale questionnaire in which the items refer to cognitive and emotional expectations of the forthcoming childbirth. The instrument will be used both as a continuous measure of level of fear, and with a cut point of ≥ 85 indicating fear of childbirth (\< 85 = no fear of childbirth)
Time frame: Baseline (around gestational week 20-25) and 6-12 months after expected delivery
The use of epidural anesthesia during delivery
Use of epidural anesthesia (yes/no) during delivery as reported in obstetric medical chart
Time frame: during delivery
Start of contractions
Induced or spontaneous start of contractions
Time frame: during delivery
Use of analgesics
Use of analgesics other than epidural
Time frame: during delivery
Mode of delivery
Vacuum extraction, forceps, Caesarean or vaginal delivery
Time frame: during delivery
Blood loss
Blood loss
Time frame: during delivery
APGAR score
APGAR at 1, 5 and 10 minutes
Time frame: after delivery
Birth weight
Birth weight
Time frame: after delivery
Admission to neonatal ward
Admission to neonatal ward
Time frame: after delivery, within 24 hours
Preferred mode of birth
Preferred mode of birth (vaginal or Caesarean)
Time frame: Baseline (around gestational week 20-25) and 6-12 months after expected delivery
Experience of giving birth
Two 100 mm visual analogue scales regarding the experience of giving birth (vaginally or with Caesarean section) using the anchors "not at all positive" to "very positive" and "not at all negative" to "very negative".
Time frame: 6-12 months after expected delivery
Experience of worst pain during delivery
100 mm visual analogue scale regarding the worst experience of pain during birth, using the anchors "not painful at all" and "worst pain possible".
Time frame: 6-12 months after expected delivery
Experience of overall pain experience during delivery
100 mm visual analogue scale regarding overall experience of pain during birth, again using the anchors "not painful at all" and "worst pain possible".
Time frame: 6-12 months after expected delivery
The Childbirth experience questionnaire
10 items with a 5-point Likert scale ranging from 1 (''completely disagree'') to 5 (''completely agree'') assessing the experience of childbirth, more specifically the distress and pain experienced
Time frame: 6-12 months after expected delivery
No study locations are listed for this record.
Plan to share: No
Started Sep 2015 (actual). Primary completion is estimated for Jan 2018, 28 months after the start.
Of 411 non-industry observational studies under Anxiety Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 49. This study's planned 28 months is above that.
Counting every sponsor, half of 439 studies reached it within 19 months; a quarter within 6 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Mid Sweden University