MothersNCT03594526
Efficacy of a Nursing Intervention in First-time Mothers
A study testing Maternal support to become mother in people with Mothers and First Birth, run by University Rovira i Virgili at 1 site in Colombia.
Trial summary
Experimental study will determine the efficacy of nursing intervention named Maternal support to become first-time mothers based on the theory of Ramona Mercer. Sequential explanatory design will be used. Read more about this study
- Who is it for?
- Ages 18 to 54 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mothers, First Birth
- What is being tested?
- Maternal support to become mother
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteColombia
- Study dates
- 2 Nov 2018to 1 Feb 2020
- 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 to 54 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Postpartum stage (for vaginal or for cesarean delivery)
- Mother of a healthy full term newborn.
- First-time mother.
- Self-declared support by her couple.
- Mother living in Bucaramanga metropolitan area
Who cannot join
- Multiple pregnancy.
- Mothers who cannot read or write.
- Diagnosis of postpartum depression, mental disorders, behavioral disorders.
- Mothers admitted to the intensive care unit after childbirth.
- Mothers with newborns hospitalized in the intensive care unit, intermediate care or minimal care.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Clinica Materno Infantil San Luis
Bucaramanga, Santander Department, 680003
About this study
Official title: Efficacy of a Nursing Intervention in the Process of Becoming a Mother, in First-time Mothers
Experimental study will determine the efficacy of nursing intervention named Maternal support to become first-time mothers based on the theory of Ramona Mercer. Sequential explanatory design will be used. It is a mixed design with approach quantitative and qualitative in order to obtain a better approach of the phenomen. The approach quantitative will be randomized controlled clinical trial. The qualitative analysis of the content will be done according to Bardin.
Read the detailed description
Taking into account the scientific literature related to studies in first-time mothers with healthy newborns, it can be concluded that the limited success of interventions that have been made suggests that the main areas of becoming a mother have not been addressed, either as part of the content or process of the interventions. This study will be conducted in 24 months. The sample size calculated will be 74 first-time mothers in total, which are allocated in two groups, intervention and control. Each group with 37 mothers.
- Conditions
- Mothers, First Birth
- Being tested
- Maternal support to become mother, Control Group: usual care
- Keywords
- Nursing Care, Mothers, Research, Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal support to become motherBehavioural
"AMACOM-PRI": Apoyo Materno para Convertirse en Madre - Primerizas. Maternal support to become first-time mothers is an intervention based on the mid-range nursing theory of Ramona Mercer, whose purpose is to empower first-time mothers in their new maternal role, favoring the mother-child bond, strengthening social support and maternal self-efficacy, consists of.
- Four Home visits , in the first week; first month of baby life; at three months; and the fourth postpartum month.
- Four Educational sessions and support sessions for maternal empowerment in each home visit.
- Telephone follow-up: at 15 days; a month and a half; at two and a half months; and three and a half months postpartum.
Control Group: usual careBehavioural
This intervention is usual care, which consists of:
- care of the mother and her newborn during the puerperium
- Teaching about breastfeeding.
| Study group | Role | What they receive |
|---|---|---|
| Maternal support to become mother | Experimental | Maternal support to become mother: is an intervention based on the mid-range nursing theory of Ramona Mercer, whose purpose is to empower first-time mothers in their new maternal role, favoring the mother-child bond, strengthening social support and maternal self-efficacy, consists of:
1. Four Home visits , in the first week; first month of baby life; at three months; and the fourth postpartum month.
2. Four Educational sessions and support sessions for maternal empowerment in each home visit.
3. Telephone follow-up: at 15 days; a month and a half; at two and a half months; and three and a half months postpartum. Receives: Behavioral: Maternal support to become mother |
| Control group: usual Care | Active comparator | The participants will receive the usual education about the care of the mother during the puerperium, the care of the newborn, including breastfeeding. Receives: Behavioral: Control Group: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale name unabbreviated: "La escala de Adopción del Rol Materno (ARM) de la Doctora María del Carmen Garrido Hidalgo y la Doctora Marleny Marchán Coronado".
Construct: This scale measures the process of maternal role adoption or "becoming mother" process; such process and this scale was created based in Ramona Mercer's theory. Conformation: It consists of 56 items distributed in 10 dimensions: 1)Interaction with the couple with respect to the baby, 2)baby acceptance, 3 Contact with the role of mother, 4)Stimulation of the baby, 5)Interaction with the family of origin regarding to the baby, 6 Baby care, 7)Maternal expressions of affection for the baby, 8)Well-being of the baby, 9)Concern and protection of the baby, 10)Knowledge and culture related to the baby. Scale Scores and Ranges: The instrument has a Likert scale (from 1 to 4). 1 = totally disagree and 4 = total agreement. The score are from 56 to 224. The classification score ranges are: low 56-180 points, medium 181-202 and high 203-224 points. The higher score across the scale indicate better adoption of the maternal role. The outcome of this scale is the sum of each linker-item.
Measured: 4 Months
Perceived Maternal Parenting Self-Efficacy (PMP S-E) by Dr. Christopher R. Barnes and Dr. Elvidina N. Adamson-Macedo: measures maternal self-efficacy.
_this scale measures Perceived Maternal Parenting Self-Efficacy.Conformation: This instrument was created by two psychologists from the University of Wolverhampton, Ireland. It has validity and reliability studies in Ireland and Brazil. It consists of 20 items distributed in 4 dimensions_ 1. Care tasks, 2. Behaviors raised, 3. Reading of behaviors or signals, 4. Situational beliefs. Scale Scores and Ranges_ the instrument has a Likert scale that goes from 1 to 4. There are 1 in totally disagree and 4 in total agreement. The instrument has a minimum score of 20 and a maximum score of 80. The higher the scores indicate greater (better) self-efficacy_
Measured: 4 months
"Perinatal Infant Care Social Support Scale" (PICSS) by Dr. Patricia Leahy-Warren: Construct: measures social support and has been widely applied in first-time mothers.
Conformation: This instrument was created by a nurse from the University of College Cork, Ireland. It has validity and reliability tests in Ireland. Consisting of two subscales, the Structural Social Support subscale measures structural social support and the Functional Social Support subscale that measures functional social support. The latter is the one that is consistent with Ramona Mercer's nursing theory. The subscale Functional Social Support consists of 16 items distributed in 4 dimensions: 1) Informative Support, 2) Instrumental Support (Physical), 3) Emotional Support, 4)Valuation Support. Dimensions: Informative support (Minimum score of 7, maximum score of 28). Instrumental support (score range 7-28). Emotional support (score range 4- 16). Valuation support (score range from 4-16). The instrument has a Likert scale from 1 to 4; 1 for totally disagree and 4 for total agreement. Score range: 22-88. As higher the score, greater (better) Structural Social Support.
Measured: 4 months
"Bond between parents and children of MSc Alix Nathalya Vargas Vásquez and Doctor Myriam Patricia Pardo Torres"
_measures the affective bond between parents and children. This instrument was created by two nurses from the National University of Colombia, Colombia. It has validity and reliability tests in Colombia and Ecuador. Conformation_ Consists of 24 items distributed in 4 dimensions_ 1. Emotional support, 2. Union - interaction, 3. Informative support, 4. Stress. Score and ranges_ the instrument has a Likert scale that goes from 0 to 5. The instrument has a minimum score_ 24 and maximum score_ 96. The low degree of affective bonding is 85 points or less
Measured: 4 months
Secondary outcomes (2)
Assessing the experience of motherhood: The Being a Mother Scale (BaM-13) - Spanish adaptation (by Drs. Lucy Marcela Vesga Gualdrón and Maria Mercedes Durán de Villalobos)
This instrument in its original English version was created by the psychologist Stephen Matthey and subsequently, based on this scale, with prior authorization, the nurses Dr. Vesga and Dr. Durán validated the Spanish scale. It is a self-report scale of 13 items. Cut point recommended is 9, which allows the classification of mothers according to the score obtained: greater than 9 is a risk of stress due to the maternal role and less than 9 is without risk of stress due to the maternal role.
Measured: 4 months
Edinburgh Postnatal Depression Scale (EPDS) of Doctors J.L. Cox; JM Holden and R. Sagovsky (Spanish)
Construct: measures postpartum depression. This instrument was created by three doctors from the University of Keele, United Kingdom. It has been widely used in several countries and has validity and reliability tests also in Colombia. It is made up of items 10. The categories of the answers are given points of 0, 1, 2 and 3 according to the increase in the severity of the symptom. The points for questions 3, 5, 6, 7, 8, 9, 10 are noted in reverse order (for example, 3, 2, 1, 0). All points are added to give the total score. Score and range: Score range from 0 to 10. A score of 10+ shows the probability of a depression, but not its severity. Any number that is chosen other than "0" for question number 10, means that it is necessary to do additional evaluations immediately. The EPDS score is designed to assist clinical judgment, do not replace the complete clinical evaluation.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start2 Nov 2018
- Primary completion20 Sep 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MothersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The assigment of the mothers to each group will be like that: The allocation will be generated in the Epidat 4.1 program. This will be done by blocks in groups of equal size, randomized 1: 1, control and intervention group. The generation will be given by an statistician who will not perform the intervention, nor the initial or final evaluations.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Vargas Porras, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594526
- Sponsor's protocol ID
- 0418
- Status last verified
- Feb 2020
- First submitted
- 6 Jul 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nakamura Y, Takeishi Y, Ito N, Ito M, Atogami F, Yoshizawa T. Comfort with motherhood in late pregnancy facilitates maternal role attainment in early postpartum. Tohoku J Exp Med. 2015 Jan;235(1):53-9. doi: 10.1620/tjem.235.53.
PubMed 25744529Maehara K, Mori E, Tsuchiya M, Iwata H, Sakajo A, Ozawa H, Morita A, Maekawa T, Makaya M, Tamakoshi K. Factors affecting maternal confidence among older and younger Japanese primiparae at one month post-partum. Jpn J Nurs Sci. 2016 Oct;13(4):424-436. doi: 10.1111/jjns.12123. Epub 2016 May 11.
PubMed 27170452Gao LL, Xie W, Yang X, Chan SW. Effects of an interpersonal-psychotherapy-oriented postnatal programme for Chinese first-time mothers: a randomized controlled trial. Int J Nurs Stud. 2015 Jan;52(1):22-9. doi: 10.1016/j.ijnurstu.2014.06.006. Epub 2014 Jun 19.
PubMed 24994573Shorey S, Chan WC, Chong YS, He HG. A randomized controlled trial of the effectiveness of a postnatal psychoeducation programme on outcomes of primiparas: study protocol. J Adv Nurs. 2015 Jan;71(1):193-203. doi: 10.1111/jan.12461. Epub 2014 Jun 9.
PubMed 24909836Shorey S, Chan SW, Chong YS, He HG. Perceptions of primiparas on a postnatal psychoeducation programme: the process evaluation. Midwifery. 2015 Jan;31(1):155-63. doi: 10.1016/j.midw.2014.08.001. Epub 2014 Aug 13.
PubMed 25174540Vargas-Porras C, Roa-Diaz ZM, Hernandez-Hincapie HG, Ferre-Grau C, de Molina-Fernandez MI. Efficacy of a multimodal nursing intervention strategy in the process of becoming a mother: A randomized controlled trial. Res Nurs Health. 2021 Jun;44(3):424-437. doi: 10.1002/nur.22123. Epub 2021 Mar 8.
PubMed 33682146
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Nursing Intervention in the Process of Becoming a Mother, in First-time Mothers
- ClinicalTrials.gov ID
- NCT03594526
- Acronym / sponsor ID
- 0418
- Conditions
- Mothers, First Birth
- Keywords
- Nursing Care, Mothers, Research, Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 20 Jul 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.
Experimental study will determine the efficacy of nursing intervention named Maternal support to become first-time mothers based on the theory of Ramona Mercer. Sequential explanatory design will be used. It is a mixed design with approach quantitative and qualitative in order to obtain a better approach of the phenomen. The approach quantitative will be randomized controlled clinical trial. The qualitative analysis of the content will be done according to Bardin.
Detailed description
Taking into account the scientific literature related to studies in first-time mothers with healthy newborns, it can be concluded that the limited success of interventions that have been made suggests that the main areas of becoming a mother have not been addressed, either as part of the content or process of the interventions. This study will be conducted in 24 months. The sample size calculated will be 74 first-time mothers in total, which are allocated in two groups, intervention and control. Each group with 37 mothers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The assigment of the mothers to each group will be like that: The allocation will be generated in the Epidat 4.1 program. This will be done by blocks in groups of equal size, randomized 1: 1, control and intervention group. The generation will be given by an statistician who will not perform the intervention, nor the initial or final evaluations.
| Arm | Type | Receives |
|---|---|---|
| Maternal support to become mother | Experimental | Behavioral: Maternal support to become motherMaternal support to become mother: is an intervention based on the mid-range nursing theory of Ramona Mercer, whose purpose is to empower first-time mothers in their new maternal role, favoring the mother-child bond, strengthening social support and maternal self-efficacy, consists of: 1. Four Home visits , in the first week; first month of baby life; at three months; and the fourth postpartum month. 2. Four Educational sessions and support sessions for maternal empowerment in each home visit. 3. Telephone follow-up: at 15 days; a month and a half; at two and a half months; and three and a half months postpartum. |
| Control group: usual Care | Active comparator | Behavioral: Control Group: usual careThe participants will receive the usual education about the care of the mother during the puerperium, the care of the newborn, including breastfeeding. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Postpartum stage (for vaginal or for cesarean delivery)
- Mother of a healthy full term newborn.
- First-time mother.
- Self-declared support by her couple.
- Mother living in Bucaramanga metropolitan area
Key exclusion criteria (5 listed)
- Multiple pregnancy.
- Mothers who cannot read or write.
- Diagnosis of postpartum depression, mental disorders, behavioral disorders.
- Mothers admitted to the intensive care unit after childbirth.
- Mothers with newborns hospitalized in the intensive care unit, intermediate care or minimal care.
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 |
|---|---|---|
| Maternal support to become mother"AMACOM-PRI": Apoyo Materno para Convertirse en Madre - Primerizas. Maternal support to become first-time mothers is an intervention based on the mid-range nursing theory of Ramona Mercer, whose purpose is to empower first-time mothers in their new maternal role, favoring the mother-child bond, strengthening social support and maternal self-efficacy, consists of. 1. Four Home visits , in the first week; first month of baby life; at three months; and the fourth postpartum month. 2. Four Educational sessions and support sessions for maternal empowerment in each home visit. 3. Telephone follow-up: at 15 days; a month and a half; at two and a half months; and three and a half months postpartum. | Behavioural | Maternal support to become mother |
| Control Group: usual careThis intervention is usual care, which consists of: 1. care of the mother and her newborn during the puerperium 2. Teaching about breastfeeding. | Behavioural | Control group: usual Care |
Primary outcome
Scale name unabbreviated: "La escala de Adopción del Rol Materno (ARM) de la Doctora María del Carmen Garrido Hidalgo y la Doctora Marleny Marchán Coronado".
Time frame: 4 Months
Construct: This scale measures the process of maternal role adoption or "becoming mother" process; such process and this scale was created based in Ramona Mercer's theory. Conformation: It consists of 56 items distributed in 10 dimensions: 1)Interaction with the couple with respect to the baby, 2)baby acceptance, 3 Contact with the role of mother, 4)Stimulation of the baby, 5)Interaction with the family of origin regarding to the baby, 6 Baby care, 7)Maternal expressions of affection for the baby, 8)Well-being of the baby, 9)Concern and protection of the baby, 10)Knowledge and culture related to the baby. Scale Scores and Ranges: The instrument has a Likert scale (from 1 to 4). 1 = totally disagree and 4 = total agreement. The score are from 56 to 224. The classification score ranges are: low 56-180 points, medium 181-202 and high 203-224 points. The higher score across the scale indicate better adoption of the maternal role. The outcome of this scale is the sum of each linker-item.
Perceived Maternal Parenting Self-Efficacy (PMP S-E) by Dr. Christopher R. Barnes and Dr. Elvidina N. Adamson-Macedo: measures maternal self-efficacy.
Time frame: 4 months
_this scale measures Perceived Maternal Parenting Self-Efficacy.Conformation: This instrument was created by two psychologists from the University of Wolverhampton, Ireland. It has validity and reliability studies in Ireland and Brazil. It consists of 20 items distributed in 4 dimensions_ 1. Care tasks, 2. Behaviors raised, 3. Reading of behaviors or signals, 4. Situational beliefs. Scale Scores and Ranges_ the instrument has a Likert scale that goes from 1 to 4. There are 1 in totally disagree and 4 in total agreement. The instrument has a minimum score of 20 and a maximum score of 80. The higher the scores indicate greater (better) self-efficacy_
"Perinatal Infant Care Social Support Scale" (PICSS) by Dr. Patricia Leahy-Warren: Construct: measures social support and has been widely applied in first-time mothers.
Time frame: 4 months
Conformation: This instrument was created by a nurse from the University of College Cork, Ireland. It has validity and reliability tests in Ireland. Consisting of two subscales, the Structural Social Support subscale measures structural social support and the Functional Social Support subscale that measures functional social support. The latter is the one that is consistent with Ramona Mercer's nursing theory. The subscale Functional Social Support consists of 16 items distributed in 4 dimensions: 1) Informative Support, 2) Instrumental Support (Physical), 3) Emotional Support, 4)Valuation Support. Dimensions: Informative support (Minimum score of 7, maximum score of 28). Instrumental support (score range 7-28). Emotional support (score range 4- 16). Valuation support (score range from 4-16). The instrument has a Likert scale from 1 to 4; 1 for totally disagree and 4 for total agreement. Score range: 22-88. As higher the score, greater (better) Structural Social Support.
"Bond between parents and children of MSc Alix Nathalya Vargas Vásquez and Doctor Myriam Patricia Pardo Torres"
Time frame: 4 months
_measures the affective bond between parents and children. This instrument was created by two nurses from the National University of Colombia, Colombia. It has validity and reliability tests in Colombia and Ecuador. Conformation_ Consists of 24 items distributed in 4 dimensions_ 1. Emotional support, 2. Union - interaction, 3. Informative support, 4. Stress. Score and ranges_ the instrument has a Likert scale that goes from 0 to 5. The instrument has a minimum score_ 24 and maximum score_ 96. The low degree of affective bonding is 85 points or less
2 secondary outcomes
Assessing the experience of motherhood: The Being a Mother Scale (BaM-13) - Spanish adaptation (by Drs. Lucy Marcela Vesga Gualdrón and Maria Mercedes Durán de Villalobos)
Time frame: 4 months
Edinburgh Postnatal Depression Scale (EPDS) of Doctors J.L. Cox; JM Holden and R. Sagovsky (Spanish)
Time frame: 4 months
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 5 Feb 2020.
- Background: PubMed 25744529Nakamura Y, Takeishi Y, Ito N, Ito M, Atogami F, Yoshizawa T. Comfort with motherhood in late pregnancy facilitates maternal role attainment in early postpartum. Tohoku J Exp Med. 2015 Jan;235(1):53-9. doi: 10.1620/tjem.235.53.
- Results publication: PubMed 27170452Maehara K, Mori E, Tsuchiya M, Iwata H, Sakajo A, Ozawa H, Morita A, Maekawa T, Makaya M, Tamakoshi K. Factors affecting maternal confidence among older and younger Japanese primiparae at one month post-partum. Jpn J Nurs Sci. 2016 Oct;13(4):424-436. doi: 10.1111/jjns.12123. Epub 2016 May 11.
- Results publication: PubMed 24994573Gao LL, Xie W, Yang X, Chan SW. Effects of an interpersonal-psychotherapy-oriented postnatal programme for Chinese first-time mothers: a randomized controlled trial. Int J Nurs Stud. 2015 Jan;52(1):22-9. doi: 10.1016/j.ijnurstu.2014.06.006. Epub 2014 Jun 19.
- Results publication: PubMed 24909836Shorey S, Chan WC, Chong YS, He HG. A randomized controlled trial of the effectiveness of a postnatal psychoeducation programme on outcomes of primiparas: study protocol. J Adv Nurs. 2015 Jan;71(1):193-203. doi: 10.1111/jan.12461. Epub 2014 Jun 9.
- Results publication: PubMed 25174540Shorey S, Chan SW, Chong YS, He HG. Perceptions of primiparas on a postnatal psychoeducation programme: the process evaluation. Midwifery. 2015 Jan;31(1):155-63. doi: 10.1016/j.midw.2014.08.001. Epub 2014 Aug 13.
- Derived from this study: PubMed 33682146Vargas-Porras C, Roa-Diaz ZM, Hernandez-Hincapie HG, Ferre-Grau C, de Molina-Fernandez MI. Efficacy of a multimodal nursing intervention strategy in the process of becoming a mother: A randomized controlled trial. Res Nurs Health. 2021 Jun;44(3):424-437. doi: 10.1002/nur.22123. Epub 2021 Mar 8.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal support to become mother in people with Mothers and First Birth, run by University Rovira i Virgili at 1 site in Colombia.
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 5 inclusion and 5 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 5 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 1 site in Colombia. 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?
Scale name unabbreviated: "La escala de Adopción del Rol Materno (ARM) de la Doctora María del Carmen Garrido Hidalgo y la Doctora Marleny Marchán Coronado". (time frame: 4 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03594526, which also lists 6 linked publications.
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 5 Feb 2020.