CClinicalTrials.gg
CompletedNCT03744416Updated Feb 25, 2020

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

An interventional study of Counseling based on Epstein's active decision making in Birth and Satisfaction, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Completed at 4 sites in Spain. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Nov 2017, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
482
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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

Read the detailed description

The birth plan (BP) is the written expression of the preferences of the pregnant woman about the management of her birth, in those cares in which there are equally effective and safe alternatives. In Spain, it was introduced into the National Health System when the "Normal Birth Attention Strategy" was developed, and in Catalonia when the Department of Health published the "Protocol to the natural assistance of normal childbirth", all with the purpose of responding to the demand of women to participate actively in their birth. Its main purpose is to promote decision-making not influenced by the emotions that arise during the birth process and to provide a communication vehicle between the future parents, the care provider and the hospital team. In addition, it allows pregnant women to understand their personal values, needs and concerns in the process of birth. The preparation of the BP can help the pregnant woman to have real expectations of childbirth, make her involved in the decision making process, thus increasing control over the birth process and having a satisfactory experience with the experience of childbirth .

Studies on the impact of the birth plan in reference on the satisfaction of women in childbirth, on obstetric outcomes and on the perception that women and professionals have of them, are scarce and inconclusive. Observational studies related that the use of BP was associated with an increase in: normal birth, late clamping of the umbilical cord, the realization of skin with skin and less use of epidural analgesia. In addition, there are researches with quantitative and qualitative methodology in which they relate the fulfillment of the BP with a greater satisfaction of the women, a greater fulfillment of the expectations and a better control of the delivery. However, others studies they do not relate it to a higher delivery satisfaction. There is also disparity between the views of midwives and women on the utility of the effect of BP on obstetric outcomes In 2016 a survey carried out in Catalonia on the satisfaction of women in the care of the maternity process showed that the overall level of satisfaction with the care received was high, 8.30 out of 10. However, women only refer who received sufficient information in pregnancy, delivery and postpartum in 67.2%, 64.2% and 57.6% respectively.

Of the different models of care relationship, the deliberative model focuses on joint collaborative work between patient and professional, in which the dialogue has a central role and shared decision-making (SDM) is present in said model . There is a large bibliography on the definition of SDM, as well as the elements that should be present in this process. According to Epstein et al, clinical decision making should be approached from the creation of a collaborative relationship with the patient and family using the best available evidence, consistent with the values, objectives and capacities of the patients. The use of decision support tools, such as support material, can help health professionals to provide information and advice on options during pregnancy and to support women in shared decision-making.

02

Conditions studied

  • Birth
  • Satisfaction

Keywords

  • birth plan
  • share decision making
  • pregnant women
  • midwife
  • satisfaction
03

In context

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 158 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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,
  • Previous placenta,
  • Isoimmunization,
  • Mild-severe preeclampsia,
  • several maternal infection
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
482 participants (actual)

Study arms

  • Experimental
    Intervention group

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

    Other: Counseling based on Epstein's active decision making

  • No intervention
    Control group

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

Interventions

  • OtherCounseling based on Epstein's active decision making

    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.

06

What researchers measure

Primary outcomes

  1. Delivery of the birth plan in hospital

    Nominal scale: yes, no

    Time frame: 6 weeks postpartum

  2. Sufficient information received in pregnancy about childbirth.

    Nominal scale: yes, no

    Time frame: 6 weeks postpartum

  3. 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.

    Time frame: 6 weeks postpartum

Secondary outcomes

  1. Reasons for non-delivery the birth plan in the hospital:

    Nominal scale: I thought it was not necessary, I forgot, the professionals who attended me did not ask me, others.

    Time frame: 6 weeks postpartum

  2. Preferences for childbirth care expressed in birth plan.

    Birth plan questionnaires. Descriptive scale. Preferences related to: procedures, pain relief methods, care during the first and second stage period, newborn care and breastfeeding

    Time frame: Until birth

  3. Degree of usefulness of the completion of the birth plan

    Scale likert from 0 to 5 : 0 is nothing useful, little useful, indifferent, quite useful 5 very useful.

    Time frame: 6 weeks postpartum

  4. Use of the birth plan in the following pregnancy

    Nominal scale: Yes, no.

    Time frame: 6 weeks postpartum

07

Study locations

4 sites
  • Catalan Health Institute
    Badalona, Barcelona 08911, Spain
  • Catalan Health Institute
    Granollers, Barcelona 08401, Spain
  • Catalan Health Institute
    Mollet Del Vallès, Barcelona 08100, Spain
  • Catalan Health Institute
    Barcelona, 08013, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03744416
Lead sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Catalan Institute of Health, University of Barcelona
Responsible party
Sponsor
First posted
Nov 16, 2018
Start date
Nov 1, 2017
Primary completion
Jul 8, 2019
Completion
Oct 25, 2019
Last update
Feb 25, 2020

Study contacts

Encarnación López-Gimeno
principal investigator · Catalan Institute of Health
Gemma Falguera-Puig, PhD
study director · Catalan Institute of Health
Gloria Seguranyes, PhD
study director · University of Barcelona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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