Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Proactive Breastfeeding Support in First Time Mothers

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Split
Sponsor:
Information provided by (Responsible Party):
Irena Zakarija-Grkovic, University of Split
ClinicalTrials.gov Identifier:
NCT01998087
First received: November 22, 2013
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Breastfeeding
Behavioral: Breastfeeding support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Written Information and Support Phone Calls for First Time Mothers on Breastfeeding Rates: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Split:

Primary Outcome Measures:
  • Exclusive breastfeeding [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Any breastfeeding [ Time Frame: 3 & 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Maternal attitudes toward infant feeding [ Time Frame: Before (at recruitment) and after (at 3 months) ] [ Designated as safety issue: No ]
    Validated Iowa Infant Feeding Attitude Scale to be used.

  • Breastfeeding self-efficacy scale [ Time Frame: At 3 months post birth ] [ Designated as safety issue: No ]
    Validated tool measuring a mother's confidence in her ability to breastfeed

  • Breastfeeding difficulties [ Time Frame: At 3 months postbirth ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: June 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01998087

Contacts
Contact: Drita Puharic, RN, MSc ++385989035526 drita.puharic@hotmail.com

Locations
Croatia
Cito Obstetrics and Gynaecology Clinic Recruiting
Split, Outside AUS, Croatia, 21000
Contact: Boris Poljak, MD    38521457800    dr.poljak@cito.hr   
Sponsors and Collaborators
University of Split
Investigators
Principal Investigator: Irena Zakarija-Grkovic, MD, PhD University of Split
  More Information

No publications provided

Responsible Party: Irena Zakarija-Grkovic, Lecturer/researcher, University of Split
ClinicalTrials.gov Identifier: NCT01998087     History of Changes
Other Study ID Numbers: 2181-198-03-04-13-0027
Study First Received: November 22, 2013
Last Updated: July 8, 2014
Health Authority: Croatia: Ethics Committee

Keywords provided by University of Split:
Exclusive breastfeeding
Breastfeeding
Proactive breastfeeding support
Telephone breastfeeding support
Infant feeding attitudes
Breastfeeding self-efficacy
Breastfeeding difficulties

ClinicalTrials.gov processed this record on November 19, 2014