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Pregnancy RelatedFADel_eduNCT03334097

Educational Intervention in the Fear-Avoidance Delivery

A study testing Prenatal education in people with Pregnancy Related, run by University of Malaga at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Related
What is being tested?
Prenatal education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteSpain
Study dates
1 Jun 2017to 1 Mar 2019
Phase
Interventional
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • No performin inclusion criteria. No voluntary participation.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Antonio Cuesta-Vargas

    Málaga, 29010

Other trials in Spain

About this study

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

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.

Read the detailed description

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.

Being tested
Prenatal education
Keywords
Pregnancy, fear, Parturition, Prenatal Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prenatal educationOther

    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:

    1. 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).
    2. 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-
    3. rd: Puerperium.
    4. rd :Breastfeeding
    5. rd : Newborn care
    6. rd :Positive parenting.
Study groups in NCT03334097
Study groupRoleWhat they receive
Experimental armExperimentalThere will only one experimental arm in order to study test-retest validity after having validate the questionnaire. The beginning of the maternal education takes place between 26 and 30 weeks of gestation and ends between 32 and 36 weeks of gestation. Hence, to study responsiveness, questionnaires will be filed at the beginning of the maternal education and after the two educational sessions related to childbirth.
Receives: Other: Prenatal education

What is being measured

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

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

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

    Measured: inmediate effect

Secondary outcomes (10)

  1. Age

    Age expressed in years

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

  2. Weight

    Weight expressed in kilograms (Kg)

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

  3. Height

    Stature expressed in meters (m)

    Measured: baseline

  4. Body Mass Index

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

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

  5. Educational level

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

    Measured: baseline

  6. Weeks of gestation

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

    Measured: baseline

  7. civil status

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

    Measured: baseline

  8. Obstetric history

    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

    Measured: baseline

  9. evolution of pregnancy

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

    Measured: baseline, inmediate effect and 2,4 and 12 weeks.

  10. Previous experience of pregnancy

    No experience, miscarriage or death

    Measured: baseline, inmediate effect and 2,4 and 12 weeks.

Timeline

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

  1. First posted7 Nov 2017
  2. Study start1 Jun 2017
  3. Primary completion31 Dec 2018
  4. Study completion1 Mar 2019

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A single groupof pregant women will complete the spanish version of Delivery Expectancy/Experience Questionnaire, Version A (WDEQ-A, spanish version) before and after an educational information.
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03334097
Sponsor's protocol ID
UMA - 2017_FAD
Acronym
FADel_edu
Status last verified
May 2017
First submitted
12 Jul 2017
Last updated
30 Sep 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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

  • Korukcu O, Kukulu K, Firat MZ. The reliability and validity of the Turkish version of the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) with pregnant women. J Psychiatr Ment Health Nurs. 2012 Apr;19(3):193-202. doi: 10.1111/j.1365-2850.2011.01694.x. Epub 2012 Jan 20.

    PubMed 22260727

  • Pallant JF, Haines HM, Green P, Toohill J, Gamble J, Creedy DK, Fenwick J. Assessment of the dimensionality of the Wijma delivery expectancy/experience questionnaire using factor analysis and Rasch analysis. BMC Pregnancy Childbirth. 2016 Nov 21;16(1):361. doi: 10.1186/s12884-016-1157-8.

    PubMed 27871320

  • Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HC. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol. 2010 Jul;63(7):737-45. doi: 10.1016/j.jclinepi.2010.02.006.

    PubMed 20494804

Questions about this trial

What is this clinical trial studying?

A study testing Prenatal education in people with Pregnancy Related, run by University of Malaga at 1 site in Spain.

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 1 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: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Responsiveness of WDEQ-A-Sp after an educational intervention (time frame: inmediate effect). 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 NCT03334097, which also lists 4 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 30 Sep 2019.

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