Proactive Breastfeeding Support in First Time Mothers

NCT01998087 | Unknown

• 1 other identifier: 2181-198-03-04-13-0027
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Exclusive breastfeeding; Breastfeeding; Proactive breastfeeding support; Telephone breastfeeding support; Infant feeding attitudes; Breastfeeding self-efficacy; Breastfeeding difficulties

Outcome Measures

Primary Outcomes (1)

• Exclusive breastfeeding

  3 months

Secondary Outcomes (1)

• Any breastfeeding

  3 & 6 months

Other Outcomes (3)

• Maternal attitudes toward infant feeding

  Before (at recruitment) and after (at 3 months)

• Breastfeeding self-efficacy scale

  At 3 months post birth

• Breastfeeding difficulties

  At 3 months postbirth

Study Arms (3)

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.

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.

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.

Interventions

Breastfeeding support BEHAVIORAL

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.

Breastfeeding support; General Support

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Split: lead

Study Sites (1)

Cito Obstetrics and Gynaecology Clinic

Split, Outside AUS, 21000, Croatia

Location

Related Publications (1)

• 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.

  PMID: 31943761 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Irena Zakarija-Grkovic, MD, PhD

  University of Split

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer/researcher

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: November 28, 2013
• Study Start: June 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

CR (1)