Proactive Breastfeeding Support in First Time Mothers

October 12, 2018 updated by: Irena Zakarija-Grkovic, University Hospital of Split

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
    • Outside AUS
      • Split, Outside AUS, Croatia, 21000
        • Cito Obstetrics and Gynaecology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breastfeeding support
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.
Behavioral: Breastfeeding support
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.
Active Comparator: General Support
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.
Behavioral: Breastfeeding support
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.
No Intervention: Standard Care
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exclusive breastfeeding
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Any breastfeeding
Time Frame: 3 & 6 months
3 & 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal attitudes toward infant feeding
Time Frame: Before (at recruitment) and after (at 3 months)
Validated Iowa Infant Feeding Attitude Scale to be used.
Before (at recruitment) and after (at 3 months)
Breastfeeding self-efficacy scale
Time Frame: At 3 months post birth
Validated tool measuring a mother's confidence in her ability to breastfeed
At 3 months post birth
Breastfeeding difficulties
Time Frame: At 3 months postbirth
At 3 months postbirth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Split

Investigators

  • Principal Investigator: Irena Zakarija-Grkovic, MD, PhD, University Hospital of Split

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

June 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 22, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (Estimate)

November 28, 2013

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 12, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2181-198-03-04-13-0027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breastfeeding

Clinical Trials on Breastfeeding support

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe