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临床试验/NCT01998087
NCT01998087Unknown不适用

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

University Hospital of Split1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

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

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.

干预措施: Breastfeeding support (Behavioral)

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.

干预措施: Breastfeeding support (Behavioral)

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.

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

发起方
University Hospital of Split
申办方类型
Other
责任方
Principal Investigator
主要研究者

Irena Zakarija-Grkovic

Lecturer/researcher

University Hospital of Split

研究点 (1)

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