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临床试验/NCT03353168
NCT03353168Unknown不适用

Childbirth Related Fear and Worry During Pregnancy

Mid Sweden University0 个研究点目标入组 499 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
499
主要终点
Fear of Birth Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Fear of Birth Scale

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

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)

Wijma Delivery Expectancy/Experience Questionnaire

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

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)

次要结局

  • The use of epidural anesthesia during delivery(during delivery)
  • Use of analgesics(during delivery)
  • Blood loss(during delivery)
  • Start of contractions(during delivery)
  • Preferred mode of birth(Baseline (around gestational week 20-25) and 6-12 months after expected delivery)
  • Experience of overall pain experience during delivery(6-12 months after expected delivery)
  • Mode of delivery(during delivery)
  • APGAR score(after delivery)
  • Birth weight(after delivery)
  • Admission to neonatal ward(after delivery, within 24 hours)
  • Experience of giving birth(6-12 months after expected delivery)
  • Experience of worst pain during delivery(6-12 months after expected delivery)
  • The Childbirth experience questionnaire(6-12 months after expected delivery)

研究者

发起方
Mid Sweden University
申办方类型
Other
责任方
Sponsor

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