BreastfeedingSTAMNCT03973476
Effectiveness of Midwife Phone Support With the to Reduce the Early Abandonment of Breastfeeding
A study testing Phone care support by midwife in people with Breastfeeding, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
Trial summary
Objective: To evaluate the effectiveness of telephone support of the reference midwife, in relation to the abandonment of breastfeeding of primiparous mothers and to identify, both the risk factors and the protective factors for the early abandonment of breastfeeding. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Phone care support by midwife
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2017
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparians who carry out the follow-up of pregnancy for the midwife
- The pregnant woman is of low risk
- Possibility of the mother to make calls to the mobile phone.
- The pregnant woman wishes to participate in the study.
Who cannot join
- Maternal or fetal pathology that can condition maternal breastfeeding.
- idiomatic barrier.
- Prematurity.
- Baby with weight <2,500 gr. at birth
- Home delivery during the puerperium
About this study
Objective: To evaluate the effectiveness of telephone support of the reference midwife, in relation to the abandonment of breastfeeding of primiparous mothers and to identify, both the risk factors and the protective factors for the early abandonment of breastfeeding.
Material and Method Randomized parallel controlled clinical trial.
Read the detailed description
Sample: 220 primiparous mothers with access, during the 8 weeks postpartum, to a mobile phone to contact the midwife randomization of 110 mothers to the experimental group and 110 to the control group. The mothers of the experimental group will be offered the mobile phone number to contact their midwife after delivery. The mothers of the control group will receive the usual attention of the portfolio of services that includes the spontaneous visit in the center, the telephone call in the center, the home visit and the health education groups.
- Conditions
- Breastfeeding
- Being tested
- Phone care support by midwife
- Keywords
- phone support; midwife; early abandonment of breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone care support by midwifeOther
Mothers can call the midwife's telephone every working day from 8 a.m. to 8 p.m.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Mothers received a phone support service with their midwife during the 8 weeks after childbirth. Receives: Other: Phone care support by midwife |
| Control group | No intervention | Mothers received standard postpartum care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who breast-feed at 3 months of intervention
Women who still breastfeed 3 months after the intervention with respect to the control arm
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Jan 2012
- Primary completion31 Dec 2014
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973476
- Sponsor's protocol ID
- P10/53-STAM
- Acronym
- STAM
- Status last verified
- Apr 2019
- First submitted
- 29 Apr 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Midwife Phone Support With the to Reduce the Early Abandonment of Breastfeeding
- ClinicalTrials.gov ID
- NCT03973476
- Acronym / sponsor ID
- STAM / P10/53-STAM
- Conditions
- Breastfeeding
- Keywords
- phone support; midwife; early abandonment of breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 4 Jun 2019 (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.
Objective: To evaluate the effectiveness of telephone support of the reference midwife, in relation to the abandonment of breastfeeding of primiparous mothers and to identify, both the risk factors and the protective factors for the early abandonment of breastfeeding.
Material and Method Randomized parallel controlled clinical trial.
Detailed description
Sample: 220 primiparous mothers with access, during the 8 weeks postpartum, to a mobile phone to contact the midwife randomization of 110 mothers to the experimental group and 110 to the control group. The mothers of the experimental group will be offered the mobile phone number to contact their midwife after delivery. The mothers of the control group will receive the usual attention of the portfolio of services that includes the spontaneous visit in the center, the telephone call in the center, the home visit and the health education groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Phone care support by midwifeMothers received a phone support service with their midwife during the 8 weeks after childbirth. |
| Control group | No intervention | –Mothers received standard postpartum care |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primiparians who carry out the follow-up of pregnancy for the midwife
- The pregnant woman is of low risk
- Possibility of the mother to make calls to the mobile phone.
- The pregnant woman wishes to participate in the study.
Key exclusion criteria (5 listed)
- Maternal or fetal pathology that can condition maternal breastfeeding.
- idiomatic barrier.
- Prematurity.
- Baby with weight <2,500 gr. at birth
- Home delivery during the puerperium
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 |
|---|---|---|
| Phone care support by midwifeMothers can call the midwife's telephone every working day from 8 a.m. to 8 p.m. | Other | Intervention group |
Primary outcome
Percentage of participants who breast-feed at 3 months of intervention
Time frame: 3 months
Women who still breastfeed 3 months after the intervention with respect to the control arm
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 4 Jun 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Phone care support by midwife in people with Breastfeeding, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
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 4 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 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of participants who breast-feed at 3 months of intervention (time frame: 3 months). 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 4 Jun 2019.