Clinical trial NCT03744416: Effectiveness of a Counseling Intervention in the Birth Plan for Pregnant Women (APLANT)
Official title: Effectiveness of a Counseling Intervention in the Birth Plan for Pregnant Women (APLANT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth
Satisfaction
Keywords: birth plan
share decision making
pregnant women
midwife
satisfaction
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Catalan Institute of Health
name: University of Barcelona
First posted: 2018-11-16
Enrollment: 482
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomised trial.
Primary purpose: OTHER

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Delivery of the birth plan in hospital
timeFrame: 6 weeks postpartum
measure: Sufficient information received in pregnancy about childbirth.
timeFrame: 6 weeks postpartum
measure: Overall satisfaction at birth and satisfaction in the degree of participation in the decision making in the first and second stage of labor.
timeFrame: 6 weeks postpartum
Secondary outcomes:
measure: Reasons for non-delivery the birth plan in the hospital:
timeFrame: 6 weeks postpartum
measure: Preferences for childbirth care expressed in birth plan.
timeFrame: Until birth
measure: Degree of usefulness of the completion of the birth plan
timeFrame: 6 weeks postpartum
measure: Use of the birth plan in the following pregnancy
timeFrame: 6 weeks postpartum
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Catalan Health Institute
state: Barcelona
city: Granollers
country: Spain
facility: Catalan Health Institute
state: Barcelona
city: Mollet Del Vallès
country: Spain
facility: Catalan Health Institute
state: Barcelona
city: Barcelona
country: Spain
facility: Catalan Health Institute
Study officials:
affiliation: Catalan Institute of Health
name: Encarnación López-Gimeno
role: PRINCIPAL_INVESTIGATOR
affiliation: Catalan Institute of Health
name: Gemma Falguera-Puig, PhD
role: STUDY_DIRECTOR
affiliation: University of Barcelona
name: Gloria Seguranyes, PhD
role: STUDY_DIRECTOR
References: