The Effect of Written Information and Support Phone Calls for First Time Mothers on Breastfeeding Rates: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Exclusive breastfeeding
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Breastfeeding support (Behavioral)
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.
干预措施: Breastfeeding support (Behavioral)
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.
结局指标
主要结局
Exclusive breastfeeding
时间窗: 3 months
次要结局
- Any breastfeeding(3 & 6 months)
研究者
Irena Zakarija-Grkovic
Lecturer/researcher
University Hospital of Split
