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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