Effectiveness of a Counseling Intervention in the Birth Plan for Pregnant Women (APLANT)

NCT03744416 | Completed

• 1 other identifier: 4R17/085-1
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 4

Brief Summary

This study assesses the effectiveness of a birt plan (BP) counseling intervention in pregnant women. Half of the pregnant women receive the intervention and the other half receive the usual practice

Conditions

Birth; Satisfaction

Keywords

birth plan; share decision making; pregnant women; midwife; satisfaction

Outcome Measures

Primary Outcomes (3)

• Delivery of the birth plan in hospital

  Nominal scale: yes, no

  6 weeks postpartum

• Sufficient information received in pregnancy about childbirth.

  Nominal scale: yes, no

  6 weeks postpartum

• Overall satisfaction at birth and satisfaction in the degree of participation in the decision making in the first and second stage of labor.

  Satisfaction Childbirth Rating Scale validate. Likert scale: very dissatisfied; little satisfied; indifferent; satisfied; very satisfied.

  6 weeks postpartum

Secondary Outcomes (4)

• Reasons for non-delivery the birth plan in the hospital:

  6 weeks postpartum

• Preferences for childbirth care expressed in birth plan.

  Until birth

• Degree of usefulness of the completion of the birth plan

  6 weeks postpartum

• Use of the birth plan in the following pregnancy

  6 weeks postpartum

Study Arms (2)

Intervention group

EXPERIMENTAL

Counseling based on Epstein's active decision making on birth plan

Other: Counseling based on Epstein's active decision making

Control group

NO INTERVENTION

The standard midwife's advice on birth plan during prenatal care.

Interventions

Counseling based on Epstein's active decision making OTHER

Birth information leaflet. Based on the best evidence practice. Midwives' training on share decision making based on Epstein model. Pregnant intervention. The pregnant women will receive from the midwives the birth plan (BP) in the prenatal check at the health center, between the 24-28 weeks, to be completed at home. Later, on the visit between 29-33 weeks, the midwives will provide the "birth information leaflet" and carry out the counseling intervention based on "shared decision making" to the pregnant women. As well, midwives will deliver a second BP that pregnant woman will fill at home. On the prenatal check between 34 to 40 weeks, the midwife will save a copy of the latest BP. The midwife will instruct the woman to deliver the BP when she arrives to the hospital for birth.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women with prenatal in the study centers
• Birth in the reference hospitals.

You may not qualify if:

• Illiteracy
• Language barrier
• Very high risk pregnancy
• Drug addiction
• Alcoholism,
• Heart disease: grade 2, 3 and 4,
• Serious associated maternal pathology,
• Type I-II diabetes,
• Uterine malformation,
• Diagnosed fetal malformation,
• Threat of premature birth,
• Twin or multiple gestation,
• Cervical incompetence,
• previous history perinatal death,
• Intrauterine growth retardation,

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Catalan Institute of Health: collaborator
• University of Barcelona: collaborator

Study Sites (4)

Catalan Health Institute

Badalona, Barcelona, 08911, Spain

Location

Catalan Health Institute

Granollers, Barcelona, 08401, Spain

Location

Catalan Health Institute

Mollet del Vallès, Barcelona, 08100, Spain

Location

Catalan Health Institute

Barcelona, 08013, Spain

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Encarnación López-Gimeno

  Catalan Institute of Health

  PRINCIPAL INVESTIGATOR

• Gemma Falguera-Puig, PhD

  Catalan Institute of Health

  STUDY DIRECTOR

• Gloria Seguranyes, PhD

  University of Barcelona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomised trial.

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: November 16, 2018
• Study Start: November 1, 2017
• Primary Completion: July 8, 2019
• Study Completion: October 25, 2019
• Last Updated: February 25, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)