NCT03334097

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 12, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

September 30, 2019

Status Verified

May 1, 2017

Enrollment Period

1.6 years

First QC Date

July 12, 2017

Last Update Submit

September 27, 2019

Conditions

Keywords

PregnancyfearParturitionPrenatal Education

Outcome Measures

Primary Outcomes (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

    inmediate effect

Secondary Outcomes (10)

  • Age

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

  • Weight

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

  • Height

    baseline

  • Body Mass Index

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

  • Educational level

    baseline

  • +5 more secondary outcomes

Study Arms (1)

Experimental arm

EXPERIMENTAL

There 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.

Other: Prenatal education

Interventions

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.

Experimental arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antonio Cuesta-Vargas

Málaga, 29010, Spain

Location

Related Publications (4)

  • 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
  • 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.

    PMID: 22260727BACKGROUND
  • 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.

    PMID: 27871320BACKGROUND
  • 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.

    PMID: 20494804BACKGROUND

MeSH Terms

Interventions

Prenatal Education

Intervention Hierarchy (Ancestors)

Patient Education as TopicHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
There will be no masking as the purpose of the study is to analyse responsiveness of a questionnaire after educational intervention
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Researcher CTS631

Study Record Dates

First Submitted

July 12, 2017

First Posted

November 7, 2017

Study Start

June 1, 2017

Primary Completion

December 31, 2018

Study Completion

March 1, 2019

Last Updated

September 30, 2019

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

Locations