ClinicalTrials.Veeva

Menu

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

F

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status

Completed

Conditions

Birth
Satisfaction

Treatments

Other: Counseling based on Epstein's active decision making

Study type

Interventional

Funder types

Other

Identifiers

NCT03744416
4R17/085-1

Details and patient eligibility

About

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

Full 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.

Enrollment

482 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

482 participants in 2 patient groups

Intervention group
Experimental group
Description:
Counseling based on Epstein's active decision making on birth plan
Treatment:
Other: Counseling based on Epstein's active decision making
Control group
No Intervention group
Description:
The standard midwife's advice on birth plan during prenatal care.

Trial contacts and locations

4

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems