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Completed

NCT Number: NCT03334097

Educational Intervention in the Fear-Avoidance Delivery

The aim of this research is to study the responsiveness of the Spanish Version of Wijma Delivery Expectancy/Experience Questionnaire, Version A (WDEQ-A) in pregnant women after an educational intervention.

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Key information

Conditions

Pregnancy Related

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Antonio Cuesta-Vargas

Málaga, 29010, Spain

About this study

The Wijma Delivery Expectancy/Experience Questionnaire is a self-report instrument designed to measure the fear of childbirth in terms of the woman's cognitive appraisal of childbirth, which is now the most commonly used measure of fear of childbirth. The version A, measures the fear before a delivery (WDEQ-A). It consists of 33 items on a 6-point Likert scale (0 = do not agree; 5 = totally agree). The total score ranges from 0 to 165; the higher the score, the greater the fear the pregnant women experience. A higher score (over 85) indicates a more intense fear of childbirth, and a score of over 100 is considered as a phobia; thus, the scale can measure individual degrees of fear among women before and after their deliveries In Spain, there is no specific instrument to test the effectiveness of different practices that are commonly used to reduce the fear of childbirth as the maternal education. Hence, after cross-cultural adaptation into Spanish of the questionnaire (WDEQ-A-Sp), the responsiveness after and educational intervention will be analysed.

Descriptive analyses will be applied to calculate means and standard deviations of the demographic variables. Distribution and normality will be determined by the one-sample Kolmogorov-Smirnov tests (significance >0.05). Responsiveness will calculated following COSMIN requirements.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Spanish women living in Málaga, > 18 years old, 26-30 weeks pregnant, to fill all the items of the questionnaires, to perform sessions the Maternal Education Protocol in Malaga

Exclusion criteria

  • No performin inclusion criteria. No voluntary participation.

Treatment and study plan

Prenatal education

Other

Education intervention will consist of a total of six sessions one week apart, with two hours of duration each one. The sessions that are exclusively oriented towards preparation for childbirth are session 1 and session 2. The content of each session is:

  • St. Birth: Start of childbirth, Symptoms and Signs, Delivery schedules, Phases of childbirth, Normal childbirth, Other circumstances (Obstetrical pathology / previous pathology, Induction of labor, Instrumental birth, Caesarean section).
  • nd:methods for relieving birth pain: Alternative Methods of Pain Relief, Pharmacological analgesia, Regional analgesia. Local and regional anesthesia, General anesthesia, breathing training and accompaniment during childbirth-
  • rd: Puerperium.
  • rd :Breastfeeding
  • rd : Newborn care
  • rd :Positive parenting.

Primary outcomes

  1. Responsiveness of WDEQ-A-Sp after an educational intervention

    Time frame: inmediate effect

    Responsiveness of Spanish Version of Wijma Delivery Expectancy/Experience Questionnaire, Version A (WDEQ-A-Sp) after an educational intervention in pregnant women

Secondary outcomes

  1. Age

    Time frame: baseline, inmediate effect and 2,4 and 12 weeks. Long time effect 6 months

    Age expressed in years

  2. Weight

    Time frame: baseline, inmediate effect and 2,4 and 12 weeks. Long time effect 6 months

    Weight expressed in kilograms (Kg)

  3. Height

    Time frame: baseline

    Stature expressed in meters (m)

  4. Body Mass Index

    Time frame: aseline, inmediate effect and 2,4 and 12 weeks. Long time effect 6 months

    Body Mass Index (BMI) expressed in kilograms per square meter (Kg/m2)

  5. Educational level

    Time frame: baseline

    Education qualification: Junior high school, High School or Degree/Master degree

  6. Weeks of gestation

    Time frame: baseline

    Weeks of gestation at the start of the study expressed in numbers

  7. civil status

    Time frame: baseline

    Marital status: married/ stable couple; Inestable couple; single

  8. Obstetric history

    Time frame: baseline

    Obstetric information if there have been previous birth(s): No pregnancy, Natural birth, natural with with epidural, instrumental delivery, cesarean operation or emergency cesarean operation

  9. evolution of pregnancy

    Time frame: baseline, inmediate effect and 2,4 and 12 weeks.

    Current pregnancy risk: low risk, medium risk or high risk

  10. Previous experience of pregnancy

    Time frame: baseline, inmediate effect and 2,4 and 12 weeks.

    No experience, miscarriage or death

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study title

Educational Intervention in the Fear-Avoidance Delivery: a Prospective Study.

Acronym: FADel_edu

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 7, 2017
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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