Skip to content

Childbirth Related Fear and Worry During Pregnancy

Childbirth Related Fear and Worry During Pregnancy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03353168
Enrollment
499
Registered
2017-11-27
Start date
2015-09-01
Completion date
2018-01-30
Last updated
2017-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Fear of Childbirth

Keywords

fear, anxiety, childbirth, pregnancy

Brief summary

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 * associations between psychological factors (pain catastrophizing, intolerance of uncertainty, worry beliefs, cognitive avoidance, insomnia, life satisfaction, anxiety- and depressive symptoms, worry parameters, and behavioral avoidance) and childbirth related fear or anxiety during pregnancy * the impact of childbirth related fear or anxiety and other psychological factors during pregnancy on epidural use during delivery and obstetric outcome variables * childbirth related fear or anxiety during pregnancy, psychological factors, epidural use, and obstetric outcome variables as predictors of self-reported birth experiences 6-10 months postpartum. * childbirth related fear or anxiety during pregnancy, psychological factors, epidural use, obstetric outcome variables, and self-reported birth experiences as predictors of childbirth related fear or anxiety 6-10 months postpartum 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.

Detailed description

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 * associations between psychological factors (pain catastrophizing, intolerance of uncertainty, worry beliefs, cognitive avoidance, insomnia, life satisfaction, anxiety- and depressive symptoms, worry parameters, and behavioral avoidance) and childbirth related fear or anxiety during pregnancy * the impact of childbirth related fear or anxiety and other psychological factors during pregnancy on epidural use during delivery and obstetric outcome variables * childbirth related fear or anxiety during pregnancy, psychological factors, epidural use, and obstetric outcome variables as predictors of self-reported birth experiences 6-10 months postpartum. * childbirth related fear or anxiety during pregnancy, psychological factors, epidural use, obstetric outcome variables, and self-reported birth experiences as predictors of childbirth related fear or anxiety 6-10 months postpartum 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: * Sociodemographic background (age, civil status, educational level, occupational status, country of birth) * Obstetric history/background (pregnancy week, number of fetuses, current pregnancy complications, previous births including birth mode and year) * Negative experiences in health care * Preferred mode of birth * the Fear of Birth Scale, FOBS * the Wijma Delivery Expectancy/Experience Questionnaire, W-DEQ A * the Hospital Anxiety and Depression Scale, HADS * the Pain Catastrophizing Scale, PCS * the Intolerance of Uncertainty Inventory, part B * Why Worry II * the Cognitive Avoidance Questionnaire * the Insomnia Severity Index, ISI * the Satisfaction With Life Scale, SWLS * the Situational Fear of Childbirth, SFC * items regarding worry frequency, controllability and excess from the GAD-7 * items regarding childbirth specific behavioral avoidance The postpartum follow-up questionnaire includes: * Birth information (birth date, birth mode including indication, usage of epidural analgesia) * the Wijma Delivery Expectancy/Experience Questionnaire, W-DEQ A * the Fear of Birth Scale, FOBS * The Childbirth Experience Questionnaire * Two 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. * One visual analogue scale regarding the worst experience of pain during birth, using the anchors not painful at all and worst pain possible. * One visual analogue scale regarding overall experience of pain during birth, again using the anchors not painful at all and worst pain possible. * Preferred mode of birth in a future birth Medical birth data that will be extracted: * Age of the mother, parity, and gestational week * Comorbidity * Obstetric and neonatal outcome variables (see outcome measures)

Interventions

None listed

Sponsors

Örebro University, Sweden
CollaboratorOTHER
Jämtland County Council, Sweden
CollaboratorOTHER_GOV
Region Örebro County
CollaboratorOTHER
Mid Sweden University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Gestational week 16 or more * Normal routine ultrasound examination * Mastery of Swedish language (being able to understand study information and questionnaires)

Exclusion criteria

* For extraction of medical birth records: giving birth in another Swedish region than Jämtland/Härjedalen or Örebro county, or giving birth in another country.

Design outcomes

Primary

MeasureTime frameDescription
Fear of Birth ScaleBaseline (around gestational week 20-25) and 6-12 months after expected deliveryTwo 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)
Wijma Delivery Expectancy/Experience QuestionnaireBaseline (around gestational week 20-25) and 6-12 months after expected delivery33 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)

Secondary

MeasureTime frameDescription
Use of analgesicsduring deliveryUse of analgesics other than epidural
Mode of deliveryduring deliveryVacuum extraction, forceps, Caesarean or vaginal delivery
Blood lossduring deliveryBlood loss
APGAR scoreafter deliveryAPGAR at 1, 5 and 10 minutes
Birth weightafter deliveryBirth weight
The use of epidural anesthesia during deliveryduring deliveryUse of epidural anesthesia (yes/no) during delivery as reported in obstetric medical chart
Preferred mode of birthBaseline (around gestational week 20-25) and 6-12 months after expected deliveryPreferred mode of birth (vaginal or Caesarean)
Experience of giving birth6-12 months after expected deliveryTwo 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.
Experience of worst pain during delivery6-12 months after expected delivery100 mm visual analogue scale regarding the worst experience of pain during birth, using the anchors not painful at all and worst pain possible.
Experience of overall pain experience during delivery6-12 months after expected delivery100 mm visual analogue scale regarding overall experience of pain during birth, again using the anchors not painful at all and worst pain possible.
The Childbirth experience questionnaire6-12 months after expected delivery10 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
Admission to neonatal wardafter delivery, within 24 hoursAdmission to neonatal ward
Start of contractionsduring deliveryInduced or spontaneous start of contractions

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026