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Fear of ChildbirthNCT03353168

Childbirth Related Fear and Worry During Pregnancy

An observational study of Fear of Childbirth and Anxiety, run by Mid Sweden University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Fear of Childbirth, Anxiety
How many people
499 participants
Where
No sites listed yet
Study dates
1 Sep 2015to 30 Jan 2018
Phase
Observational
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

Study population: A general sample of pregnant Swedish women, recruted at antenatal health care units within primary care.

Who may be able to join

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

Who cannot join

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

About this study

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.

Read the 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)
Keywords
fear, anxiety, childbirth, pregnancy
Medical subject headings
Anxiety Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline (around gestational week 20-25) and 6-12 months after expected delivery

  2. 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)

    Measured: Baseline (around gestational week 20-25) and 6-12 months after expected delivery

Secondary outcomes (13)
  1. The use of epidural anesthesia during delivery

    Use of epidural anesthesia (yes/no) during delivery as reported in obstetric medical chart

    Measured: during delivery

  2. Start of contractions

    Induced or spontaneous start of contractions

    Measured: during delivery

  3. Use of analgesics

    Use of analgesics other than epidural

    Measured: during delivery

  4. Mode of delivery

    Vacuum extraction, forceps, Caesarean or vaginal delivery

    Measured: during delivery

  5. Blood loss

    Blood loss

    Measured: during delivery

  6. APGAR score

    APGAR at 1, 5 and 10 minutes

    Measured: after delivery

  7. Birth weight

    Birth weight

    Measured: after delivery

  8. Admission to neonatal ward

    Admission to neonatal ward

    Measured: after delivery, within 24 hours

  9. Preferred mode of birth

    Preferred mode of birth (vaginal or Caesarean)

    Measured: Baseline (around gestational week 20-25) and 6-12 months after expected delivery

  10. 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".

    Measured: 6-12 months after expected delivery

  11. 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".

    Measured: 6-12 months after expected delivery

  12. 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".

    Measured: 6-12 months after expected delivery

  13. 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

    Measured: 6-12 months after expected delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2017
  2. Study start1 Sep 2015
  3. Primary completion1 Jan 2018 (estimated)
  4. Study completion30 Jan 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
499 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03353168
Sponsor's protocol ID
2014/372-31Ö
Status last verified
Nov 2017
First submitted
19 Jul 2017
Last updated
27 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Haines H, Pallant JF, Karlstrom A, Hildingsson I. Cross-cultural comparison of levels of childbirth-related fear in an Australian and Swedish sample. Midwifery. 2011 Aug;27(4):560-7. doi: 10.1016/j.midw.2010.05.004. Epub 2010 Jul 3.

    PubMed 20598787
  • Wijma K, Wijma B, Zar M. Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. J Psychosom Obstet Gynaecol. 1998 Jun;19(2):84-97. doi: 10.3109/01674829809048501.

    PubMed 9638601
  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PubMed 6880820
  • Sullivan, M.J.L., Bishop, S.R., Pivik, J. The Pain Catastrophizing Scale: Development and validation. Psychological Assessment 7: 524-532, 1995

  • Carleton RN, Gosselin P, Asmundson GJ. The intolerance of uncertainty index: replication and extension with an English sample. Psychol Assess. 2010 Jun;22(2):396-406. doi: 10.1037/a0019230.

    PubMed 20528066
  • Gosselin P, Ladouceur R, Evers A, Laverdiere A, Routhier S, Tremblay-Picard M. Evaluation of intolerance of uncertainty: development and validation of a new self-report measure. J Anxiety Disord. 2008 Dec;22(8):1427-39. doi: 10.1016/j.janxdis.2008.02.005. Epub 2008 Mar 2.

    PubMed 18395409
  • Hebert, E. A., Dugas, M. J., Tulloch, T. G., & Holowka, D. W. (2014). Positive beliefs about worry: A psychometric evaluation of the Why Worry-II. Personality and Individual Differences, 56, 3-8.

  • Freeston, M. H., Rhéaume, J., Letarte, H., Dugas, M. J., & Ladouceur, R. (1994). Why do people worry? Personality and Individual Differences, 17(6), 791-802. doi:10.1016/0191-8869(94)90048-5

  • Sexton KA, Dugas MJ. The Cognitive Avoidance Questionnaire: validation of the English translation. J Anxiety Disord. 2008;22(3):355-70. doi: 10.1016/j.janxdis.2007.04.005. Epub 2007 Apr 25.

    PubMed 17544253
  • Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

    PubMed 11438246
  • Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.

    PubMed 16367493
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PubMed 16717171
  • Van den Bussche E, Crombez G, Eccleston C, Sullivan MJ. Why women prefer epidural analgesia during childbirth: the role of beliefs about epidural analgesia and pain catastrophizing. Eur J Pain. 2007 Apr;11(3):275-82. doi: 10.1016/j.ejpain.2006.03.002. Epub 2006 Apr 18.

    PubMed 16624602

Questions about this trial

What is this clinical trial studying?

An observational study of Fear of Childbirth and Anxiety, run by Mid Sweden University.

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 3 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: status not confirmed, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Fear of Birth Scale (time frame: Baseline (around gestational week 20-25) and 6-12 months after expected delivery). The study lists 2 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 NCT03353168, which also lists 13 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 27 Nov 2017.

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