NCT03353168

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
499

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

2.3 years

First QC Date

July 19, 2017

Last Update Submit

November 22, 2017

Conditions

Keywords

fearanxietychildbirthpregnancy

Outcome Measures

Primary Outcomes (2)

  • 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)

    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)

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

Secondary Outcomes (13)

  • The use of epidural anesthesia during delivery

    during delivery

  • Start of contractions

    during delivery

  • Use of analgesics

    during delivery

  • Mode of delivery

    during delivery

  • Blood loss

    during delivery

  • +8 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 20598787BACKGROUND
  • 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.

    PMID: 9638601BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

    PMID: 20528066BACKGROUND
  • 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.

    PMID: 18395409BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 17544253BACKGROUND
  • 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.

    PMID: 11438246BACKGROUND
  • 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.

    PMID: 16367493BACKGROUND
  • 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.

    PMID: 16717171BACKGROUND
  • 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.

    PMID: 16624602BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Johanna Ekdahl, PhD

    Depratment of Psychology, Mid Seden University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2017

First Posted

November 27, 2017

Study Start

September 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 30, 2018

Last Updated

November 27, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share