BirthNCT03744416
Effectiveness of a Counseling Intervention in the Birth Plan for Pregnant Women (APLANT)
A study testing Counseling based on Epstein's active decision making in people with Birth and Satisfaction, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 4 sites in Spain.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth, Satisfaction
- What is being tested?
- Counseling based on Epstein's active decision making
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- 4 sitesSpain
- Study dates
- 1 Nov 2017to 25 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women with prenatal in the study centers
- Birth in the reference hospitals.
Who cannot join
- Illiteracy
- Language barrier
- Very high risk pregnancy
- Drug addiction
- Alcoholism,
- Heart disease: grade 2, 3 and 4,
Show all 19Show fewer
- 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 locations and contacts
4 sites in 1 country.
Spain4 sites
Catalan Health Institute
Badalona, Barcelona, 08911
Catalan Health Institute
Barcelona, 08013
Catalan Health Institute
Granollers, Barcelona, 08401
Catalan Health Institute
Mollet del Vallès, Barcelona, 08100
About this study
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.
- Conditions
- Birth, Satisfaction
- Being tested
- Counseling based on Epstein's active decision making
- Keywords
- birth plan, share decision making, pregnant women, midwife, satisfaction
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling based on Epstein's active decision makingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Counseling based on Epstein's active decision making on birth plan Receives: Other: Counseling based on Epstein's active decision making |
| Control group | No intervention | The standard midwife's advice on birth plan during prenatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery of the birth plan in hospital
Nominal scale: yes, no
Measured: 6 weeks postpartum
Sufficient information received in pregnancy about childbirth.
Nominal scale: yes, no
Measured: 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.
Measured: 6 weeks postpartum
Secondary outcomes (4)
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.
Measured: 6 weeks postpartum
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
Measured: Until birth
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.
Measured: 6 weeks postpartum
Use of the birth plan in the following pregnancy
Nominal scale: Yes, no.
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Nov 2017
- Primary completion8 Jul 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomised trial.
- Masking
- None (open label)
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Catalan Institute of Health, University of Barcelona
- Responsible party
- Sponsor
- Investigators
- Encarnación López-Gimeno, Principal investigator, Catalan Institute of HealthGemma Falguera-Puig, PhD, Study director, Catalan Institute of HealthGloria Seguranyes, PhD, Study director, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744416
- Sponsor's protocol ID
- 4R17/085-1
- Status last verified
- Aug 2019
- First submitted
- 23 Oct 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Counseling Intervention in the Birth Plan for Pregnant Women (APLANT)
- ClinicalTrials.gov ID
- NCT03744416
- Acronym / sponsor ID
- 4R17/085-1
- Conditions
- Birth, Satisfaction
- Keywords
- birth plan, share decision making, pregnant women, midwife, satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Catalan Institute of Health, University of Barcelona
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 8 Jul 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomised trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Counseling based on Epstein's active decision makingCounseling based on Epstein's active decision making on birth plan |
| Control group | No intervention | –The standard midwife's advice on birth plan during prenatal care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women with prenatal in the study centers
- Birth in the reference hospitals.
Key exclusion criteria (19 listed)
- Illiteracy
- Language barrier
- Very high risk pregnancy
- Drug addiction
- Alcoholism,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counseling based on Epstein's active decision makingBirth 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. | Other | Intervention group |
Primary outcome
Delivery of the birth plan in hospital
Time frame: 6 weeks postpartum
Nominal scale: yes, no
Sufficient information received in pregnancy about childbirth.
Time frame: 6 weeks postpartum
Nominal scale: yes, no
Overall satisfaction at birth and satisfaction in the degree of participation in the decision making in the first and second stage of labor.
Time frame: 6 weeks postpartum
Satisfaction Childbirth Rating Scale validate. Likert scale: very dissatisfied; little satisfied; indifferent; satisfied; very satisfied.
4 secondary outcomes
Reasons for non-delivery the birth plan in the hospital:
Time frame: 6 weeks postpartum
Preferences for childbirth care expressed in birth plan.
Time frame: Until birth
Degree of usefulness of the completion of the birth plan
Time frame: 6 weeks postpartum
Use of the birth plan in the following pregnancy
Time frame: 6 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling based on Epstein's active decision making in people with Birth and Satisfaction, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery of the birth plan in hospital (time frame: 6 weeks postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.