Proactive Breastfeeding Support in First Time Mothers

Breastfeeding Clinical Trial

Official title:

The Effect of Written Information and Support Phone Calls for First Time Mothers on Breastfeeding Rates: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01998087
• Other study ID #: 2181-198-03-04-13-0027
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2014
• Est. completion date: December 2018

Study information

• Verified date: October 2018
• Source: University Hospital of Split
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding

Intervention

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.

Locations

Country	Name	City	State
Croatia	Cito Obstetrics and Gynaecology Clinic	Split	Outside AUS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Split

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal attitudes toward infant feeding	Validated Iowa Infant Feeding Attitude Scale to be used.	Before (at recruitment) and after (at 3 months)
Other	Breastfeeding self-efficacy scale	Validated tool measuring a mother's confidence in her ability to breastfeed	At 3 months post birth
Other	Breastfeeding difficulties		At 3 months postbirth
Primary	Exclusive breastfeeding		3 months
Secondary	Any breastfeeding		3 & 6 months