BreastfeedingNCT01998087
Proactive Breastfeeding Support in First Time Mothers
A study testing Breastfeeding support in people with Breastfeeding, run by University Hospital of Split at 1 site in Croatia.
Trial summary
In Croatia, between 95% and 99% of mothers initiate breastfeeding, but by 3 months a third have stopped, and by six months only half are still providing any human milk for their babies. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Breastfeeding support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCroatia
- Study dates
- Jun 2014to Dec 2018
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- expectant women, between 20 and 32 weeks gestation, attending any of 6 pre- determined antenatal clinics
- primigravidae
- singleton pregnancy
- can read and write Croatian
- resides in Croatia or plans to stay in Croatia at least 12 months following the birth
Who cannot join
- multigravidae
- women expecting twins/multiples
- refuses to participate
- inability to communicate in Croatian by phone
- planning to leave the County of Split Dalmatia within a year of giving birth
- severe maternal psychiatric or medical problems
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Cito Obstetrics and Gynaecology Clinic
Split, Outside AUS, 21000
About this study
Official title: The Effect of Written Information and Support Phone Calls for First Time Mothers on Breastfeeding Rates: A Randomized Controlled Trial
In Croatia, between 95% and 99% of mothers initiate breastfeeding, but by 3 months a third have stopped, and by six months only half are still providing any human milk for their babies. Exclusive breastfeeding rates are even lower, with only about 9% of Croatian mothers exclusively breastfeeding at 6 months, despite the WHO recommendation of 6 months of exclusive breastfeeding. Currently, in Croatia, no breastfeeding information or other pregnancy and parenting related written information is routinely provided to expectant couples. In our study we would like to find out whether providing written breastfeeding information in pregnancy and breastfeeding focused support phone calls during pregnancy and after the birth of the baby result in better outcomes than providing general pregnancy/parenting information and support phone calls. This will be tested by randomising women, attending their primary health care provider for routine antenatal visits between 20 and 32 weeks, to an intervention focused on promoting and supporting breastfeeding, to an intervention focused on general pregnancy and parenting issues, and to a non-intervention control group. Women will be followed-up for 6 months after the birth of their baby and data will be collected at 3 and 6 months on breastfeeding rates, breastfeeding self-efficacy, breastfeeding difficulties, social support and attitudes toward infant feeding.
- Conditions
- Breastfeeding
- Being tested
- Breastfeeding support
- Keywords
- Exclusive breastfeeding, Breastfeeding, Proactive breastfeeding support, Telephone breastfeeding support, Infant feeding attitudes, Breastfeeding self-efficacy, Breastfeeding difficulties
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding supportBehavioural
A breastfeeding brochure will be distributed to expectant mothers from 20 weeks gestation during their regular antenatal visit. This will be followed 2 weeks later by a phone call offering clarification/explanation of the brochure. Three phone calls, offering breastfeeding support, will be conducted at 2,6 and 10 weeks following the birth of the baby.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding support | Experimental | A breastfeeding brochure will be distributed to expectant mothers from 20 weeks gestation during their regular antenatal visit. This will be followed 2 weeks later by a phone call offering clarification/explanation of the brochure. Three standardized phone calls, offering breastfeeding support, will be conducted at 2,6 and 10 weeks following birth of the baby. Receives: Behavioral: Breastfeeding support |
| General Support | Active comparator | The active control group of mothers will receive a brochure in pregnancy covering general pregnancy and parenting issues and follow-up phone calls but breastfeeding issues will not be specifically addressed. If a mother raises any breastfeeding issue she will be referred to appropriate support. Receives: Behavioral: Breastfeeding support |
| Standard Care | No intervention | This group will receive standard antenatal care provided by their chosen gynaecologist and obstetrician, consisting of regular antenatal visits. No written materials or telephone calls are routinely provided to pregnant women in Croatia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive breastfeeding
Measured: 3 months
Secondary outcomes (1)
Any breastfeeding
Measured: 3 & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startJun 2014
- Primary completionJun 2017
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irena Zakarija-Grkovic, University Hospital of Split
- Investigators
- Irena Zakarija-Grkovic, MD, PhD, Principal investigator, University of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998087
- Sponsor's protocol ID
- 2181-198-03-04-13-0027
- Status last verified
- Oct 2018
- First submitted
- 22 Nov 2013
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Puharic D, Malicki M, Borovac JA, Sparac V, Poljak B, Aracic N, Marinovic N, Luetic N, Zakarija-Grkovic I. The effect of a combined intervention on exclusive breastfeeding in primiparas: A randomised controlled trial. Matern Child Nutr. 2020 Jul;16(3):e12948. doi: 10.1111/mcn.12948. Epub 2020 Jan 13.
PubMed 31943761
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Written Information and Support Phone Calls for First Time Mothers on Breastfeeding Rates: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01998087
- Acronym / sponsor ID
- 2181-198-03-04-13-0027
- Conditions
- Breastfeeding
- Keywords
- Exclusive breastfeeding, Breastfeeding, Proactive breastfeeding support, Telephone breastfeeding support, Infant feeding attitudes, Breastfeeding self-efficacy, Breastfeeding difficulties
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 28 Nov 2013 (estimated)
- 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.
In Croatia, between 95% and 99% of mothers initiate breastfeeding, but by 3 months a third have stopped, and by six months only half are still providing any human milk for their babies. Exclusive breastfeeding rates are even lower, with only about 9% of Croatian mothers exclusively breastfeeding at 6 months, despite the WHO recommendation of 6 months of exclusive breastfeeding. Currently, in Croatia, no breastfeeding information or other pregnancy and parenting related written information is routinely provided to expectant couples. In our study we would like to find out whether providing written breastfeeding information in pregnancy and breastfeeding focused support phone calls during pregnancy and after the birth of the baby result in better outcomes than providing general pregnancy/parenting information and support phone calls. This will be tested by randomising women, attending their primary health care provider for routine antenatal visits between 20 and 32 weeks, to an intervention focused on promoting and supporting breastfeeding, to an intervention focused on general pregnancy and parenting issues, and to a non-intervention control group. Women will be followed-up for 6 months after the birth of their baby and data will be collected at 3 and 6 months on breastfeeding rates, breastfeeding self-efficacy, breastfeeding difficulties, social support and attitudes toward infant feeding.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding support | Experimental | Behavioral: Breastfeeding supportA breastfeeding brochure will be distributed to expectant mothers from 20 weeks gestation during their regular antenatal visit. This will be followed 2 weeks later by a phone call offering clarification/explanation of the brochure. Three standardized phone calls, offering breastfeeding support, will be conducted at 2,6 and 10 weeks following birth of the baby. |
| General Support | Active comparator | Behavioral: Breastfeeding supportThe active control group of mothers will receive a brochure in pregnancy covering general pregnancy and parenting issues and follow-up phone calls but breastfeeding issues will not be specifically addressed. If a mother raises any breastfeeding issue she will be referred to appropriate support. |
| Standard Care | No intervention | –This group will receive standard antenatal care provided by their chosen gynaecologist and obstetrician, consisting of regular antenatal visits. No written materials or telephone calls are routinely provided to pregnant women in Croatia. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- expectant women, between 20 and 32 weeks gestation, attending any of 6 pre- determined antenatal clinics
- primigravidae
- singleton pregnancy
- can read and write Croatian
- resides in Croatia or plans to stay in Croatia at least 12 months following the birth
Key exclusion criteria (6 listed)
- multigravidae
- women expecting twins/multiples
- refuses to participate
- inability to communicate in Croatian by phone
- planning to leave the County of Split Dalmatia within a year of giving birth
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 |
|---|---|---|
| Breastfeeding supportA breastfeeding brochure will be distributed to expectant mothers from 20 weeks gestation during their regular antenatal visit. This will be followed 2 weeks later by a phone call offering clarification/explanation of the brochure. Three phone calls, offering breastfeeding support, will be conducted at 2,6 and 10 weeks following the birth of the baby. | Behavioural | Breastfeeding support, General Support |
Primary outcome
Exclusive breastfeeding
Time frame: 3 months
1 secondary outcome
Any breastfeeding
Time frame: 3 & 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 31943761Puharic D, Malicki M, Borovac JA, Sparac V, Poljak B, Aracic N, Marinovic N, Luetic N, Zakarija-Grkovic I. The effect of a combined intervention on exclusive breastfeeding in primiparas: A randomised controlled trial. Matern Child Nutr. 2020 Jul;16(3):e12948. doi: 10.1111/mcn.12948. Epub 2020 Jan 13.
- Individual participant dataSharing planned: Yes
Related trials for Breastfeeding
Enrolling by invitation
The Effect of Breastfeeding Education Delivered Via a Hybrid Model on Breastfeeding Efficacy and Postpartum Comfort Levels
Breastfeeding, Postpartum Comfort
Not yet recruiting
THE EFFECT OF A VIRTUAL REALITY BREASTFEEDING EXPERIENCE ON BREASTFEEDING EXPECTATIONS AND AVOIDANCE
Breastfeeding Expectations, Breastfeeding Avoidance
RecruitingObservational study
A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding
Fabry Disease
Not yet recruiting
Effect of a Breastfeeding Chatbot on Mothers' Breastfeeding Attitudes, Behaviors, and Self-Efficacy
Breastfeeding, Breastfeeding Attitudes
Recruiting
Effect of Solution-Focused Approach Education on Breastfeeding Avoidance and Breastfeeding Self-Efficacy in Primiparous Mothers
Breastfeeding Avoidance and Breastfeeding Self-efficacy
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.
Irena Zakarija-Grkovic, MD, PhD principal investigator
University of Split
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding support in people with Breastfeeding, run by University Hospital of Split at 1 site in Croatia.
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 6 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: status not confirmed, as of the sponsor's last update on 15 Oct 2018. 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 Croatia. 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?
Results are not available in the source record.
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?
Exclusive breastfeeding (time frame: 3 months). 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 NCT01998087, which also lists 1 linked publication.
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 15 Oct 2018.