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Table 3. Characteristics of Randomized, Controlled Trials

Study, Year
(Reference)
Design Country Patients, n Population Characteristics Intervention Components Timing Control Outcomes Qualitya
Developed countries
Anderson et al., 200593 Parallel United States 182 Predominantly Latina and low-income, WIC LS Prenatal, peripartum, postnatal BFHIb Breastfeeding rates, maternal and child health Fair
Bonuck et al., 200594 and 200695 Parallel United States; 382 56% Medicaid, 39% foreign-born Ed, PS-IL, provided nursing bras and pump Prenatal, peripartum, postnatal Usual prenatal care Breastfeeding rates, maternal and child health Fair
Carfoot et al., 200496,c Parallel United Kingdom 28 General(sparse demographic data) Skin-to-skin contact Postnatal Routine care Breastfeeding rates Poor
Carfoot et al., 200597 Parallel United Kingdom 201 General (sparse demographic data) Skin-to-skin contact Postnatal Routine care Breastfeeding rates Fair
Chapman et al., 2004117 Parallel United States 219 Latino community from Puerto Rico, low-income, BFHI-accredited hospital LS, provided electric breast pumps Prenatal, peripartum, postnatal Routine Ed Breastfeeding rates Fair
Dennis et al., 2002118 Parallel Canada 256 General, well-educated (>60% college education) LS, telephonebased support Postnatal Conventional in-hospital and community postpartum support Breastfeeding rates Fair
Di Napoli et al., 2004124 Parallel Italy 605 General, well-educated PS-IL, telephonebased support Postnatal No intervention Breastfeeding rates Fair
Ekström and Nissen, 2006130;
Ekström et al., 2006131
Quasi Sweden 378 Large municipalities, well-educated PS-SLd Prenatal, peripartum Usual care Breastfeeding rates, absolute breastfeeding durations Poor
Finch and Daniel, 200299 Parallel United States 60 Low-income (urban WIC program), African- American and Hispanic, 25% ≥18 years old Ed, incentives Prenatal, peripartum Usual prenatal care Breastfeeding rates Poor
Forster et al., 2004100 Parallel Australia 981 Low-income, culturally diverse, BFHI-accredited hospital Ed e Prenatal, peripartum BFHIf Breastfeeding rates, absolute breastfeeding durations Fair
Gagnon et al., 2002119 Parallel Canada 586 General (living near the urban hospital) S-ILg, telephonebased support Postnatal Usual care in hospital and clinical follow-up Breastfeeding rates, absolute breastfeeding durations Fair
Graffy et al., 2004123 Parallel United Kingdom 720 General (urban areas) PS-ILh Prenatal, peripartum, postnatal Usual care with no counselor contact Breastfeeding rates Good
Henderson et al., 2001101 Parallel Australia 160 2–3-d postpartum stay, well-educated Ed Postnatal Usual postpartum care Breastfeeding rates Fair
Howard et al., 2003102 Parallel United States 700 Primarily white, well-educated, married, 77% employed Delayed pacifier use (>4 wk) Postnatal Early pacifier use (2–5 d) Absolute breastfeeding durations Good
Kools et al., 2005129 Cluster ; Netherlands 781 General, well-educated PS-ILi Prenatal, peripartum, postnatal PS plus written material Breastfeeding rates Fair
Kramer et al., 2001103 Parallel Canada 281 Multicultural (67% Englishspeaking), well-educated, 76% employed PS-IL, discouraged pacifier use Postnatal Pacifier use and PS Breastfeeding rates Good
Kronborg et al., 2007128 Cluster Denmark 1597 General, BFHI-accredited hospitals PS-IL Postnatal Home visits by health visitors who did not have the training course Breastfeeding rates Fair
Labarere et al., 2003104 Parallel France 212 Employed, well-educated, prolonged maternity leave Ed Postnatal Usual care in hospital Breastfeeding rates Good
Labarere et al., 2005105 Parallel France 231 Well-educated, employed, prolonged hospital stay PS-SLj Postnatal Usual care, including LS Breastfeeding rates, absolute breastfeeding durations Good
Lavender et al., 2005127 Cluster United Kingdom 742 Low-income, lack of social support PS-SLk Prenatal, peripartum Usual prenatal breastfeeding advice Breastfeeding rates Poor
Mattar et al., 2007114 Parallel Singapore 401 Low-income, less-educated PS-ILl, Ed materials(book and video) Prenatal, peripartum Routine prenatal care Breastfeeding rates Good
McKeever et al., 2002106 Parallel Canada 101 Metropolitan area, well-educated, about a 48-h postpartum stay PS-IL Postnatal No home visits from lactation nurses Breastfeeding rates Poor
McLeod et al., 2004132 Quasi New Zealand 228 Maori, smokers Edm, PS-IL Prenatal, peripartum, postnatal Usual care for women who smoked Breastfeeding rates Poor
Mizuno et al., 2004107 Parallel Japan 60 Postpartum stay ≥4 d, infants not with mothers for 24 h and were fed formula Skin-to-skin contact Postnatal Routine care Breastfeeding rates, absolute breastfeeding durations Fair
Moore and Anderson, 2007115 Parallel United States 21 General, well-educated Skin-to-skin contact Postnatal Routine care Breastfeeding rates Poor
Muirhead et al., 2006108 Parallel Scotland 225 Some premature babies (5.3%) and babies in special care, few demographic data on the mothers LS Prenatal, peripartum, postnatal Usual caren Breastfeeding rates Fair
Noel-Weiss et al., 2006125 Parallel Canada 101 High family income, well-educated, 36% cesarean section, 68% received free formula Ed Prenatal,peripartum Not described (no education) Breastfeeding rates, absolute breastfeeding durations Good
Pugh et al., 2002120 Parallel United States 41 Low-income, receiving financial medical assistance PS-IL, LS Postnatal Usual care Breastfeeding rates Poor
Quinlivan et al., 2003121 Parallel Australia 136 Age <18 y PS-IL Postnatal Routine postnatal support Breastfeeding rates, absolute breastfeeding durations Good
Ryser, 2004109 Parallel United States 54 Low-income (90% eligible for Medicaid) Ed Prenatal, peripartum No intervention Breastfeeding rates Poor
Schlickau and Wilson, 2005110 Parallel United States 30 Hispanic women, emigrated from Mexico Ed, commitment to breastfeedo Prenatal, peripartum Usual care Breastfeeding rates, absolute breastfeeding durations Poor
Su et al., 2007116 Parallel Singapore 450 Low-income, less-educated PS-ILp, printed materials Prenatal, peripartum, postnatal Usual care Breastfeeding rates Fair
Wallace et al., 2006111 Parallel United Kingdom 270 General (not BFHI-accredited hospital) PS-SLq Postnatal Usual postpartum care Breastfeeding rates Good
Wilhelm et al., 2006112 Parallel United States 73 Rural community Motivational interview Postnatal Usual carer Breastfeeding rates, absolute breastfeeding durations Poor
Winterburn et al., 2003122 Parallel United Kingdom 72 No data (women in a university hospital) PS-IL, LSs Prenatal, peripartum Routine prenatal care Breastfeeding rates Poor
Wolfberg et al., 2004113 Parallel United States 59 Low-income, minority Edt Prenatal, peripartum Control education (baby care and safety) Breastfeeding rates Poor
Developing countries (for BFHI only)
Coutinho et al., 200598 Parallel Brazil 350 Low-income, 24-h hospital stay PS-ILu Prenatal, peripartum, postnatal BFHI (steps 4–9)v Breastfeeding rates Good
Kramer et al., 2001126 Cluster Belarus 17 046 Prolonged postpartum stay; maternity leave PS-SLw Prenatal, peripartum, postnatal Usual care Breastfeeding rates, maternal and child health Good

BHFI = Baby-Friendly Hospital Initiative; Ed = formal/structured breastfeeding education; LS = lay support; PS = professional support; PS-IL = professional support—individual level; PS-SL = professional support—system level; WIC = Women, Infants, and Children program.
a See Appendix Table for the detailed quality assessment.
b BFHI: breastfeeding warm line (telephone support), conventional breastfeeding education before birth, hands-on breastfeeding assistance, and education from the maternity ward nursing staff.
c Pilot study for reference 97.
d Health professionals received a process-oriented program on breastfeeding counseling, including lectures on breastfeeding management and promotion, counseling skills, and personal breastfeeding experiences.
e Two intervention groups: practical skills or attitudes.
f Standard care included formal breastfeeding education, peer support, and postnatal home visits by midwives (BFHI-accredited hospital); the same control group was used to compare both intervention groups (practical skills or attitudes).
g Community follow-up (intervention group): telephone contact 48 hours after delivery and nurse contact in the home on day 3.
h Trained, accredited counselors who visited once before birth, followed by telephone support or home visits if requested.
i Enhanced access to lactation consultants.
j Pediatricians or family physicians who had attended a 5-hour training program (breastfeeding-related knowledge and counseling skills) delivered in 2 parts in 1 month before the beginning of the study.
k Education session (1 day, 9 a.m.–4 p.m.) to help midwives revise their knowledge of lactation management and educate women on basic lactation physiology and effective breastfeeding techniques.
l Two intervention groups: education materials (book and video) and individual counseling (1 session) or education materials (book and video) alone.
m Two intervention groups: breastfeeding support only or breastfeeding support and smoking cessation.
n Usual care included a community midwife for the first 10 days, health visitor after 10 days, breastfeeding support groups, and breastfeeding workshops.
o Two intervention groups: breastfeeding education or breastfeeding education plus commitment to breastfeed.
p Two intervention groups: 1) 1-session video before birth, printed materials, or 15-minute counseling with lactation consultant or 2) counseling sessions after delivery (30 minutes each with lactation consultant) and printed materials.
q Midwives received a 4-hour workshop ("hands-off" approach to breastfeeding: advice about baby initiation of feeding, positioning, and attachment).
r Usual care included a lactation consultant troubleshooting problems during the hospital stay and at each visit by using the American Academy of Pediatrics’ 2002 guide to breastfeeding.
s Members of the intervention group were invited to choose a female confidante who could offer support with infant feeding, and the community midwife visited both mother and confidante together at home.
t Breastfeeding classes for expectant fathers taught by peer who was a father.
u BFHI step 10, postnatal home visits by professionals.
v BFHI step 4, skin-to-skin contact in delivery room and helped to breastfeed in delivery room; BFHI step 5, shown how to breastfeed (positioning and attachment); BFHI step 6, infant given only breast milk, given no water/tea, and given no other milk; BFHI step 7, roomed-in; BFHI step 8, advised to breastfeed on demand; BFHI step 9, advised not to give pacifiers and bottles; and BFHI step 10, postnatal home visits by professionals.
w Modeled BFHI.

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