Rasmussen 2011b.
Methods | 3‐armed RCT to determine if women who were overweight or obese who received an electric or a manual pump would breastfeed for longer than those receiving usual care | |
Participants | Setting: a hospital in a rural part of New York, USA, which has a history of promoting and supporting breastfeeding Recruitment: infants born March 2007‐December 2007 Inclusion criteria: women with a pre‐pregnancy BMI > 29 kg/m², who were intending to breastfeed, had no history of breast surgery, who were at least 19 years old and had a singleton fetus and were ≤ 35 weeks' gestation at enrolment to the study. Women were recruited if they resided near to the recruiting healthcare centre. Exclusion criteria: after enrolment women were excluded if they gave birth outside of the study data collection period, if their infant was not born at term, if the infant was never put to the breast, if the infant was injured during delivery, if the infant was placed into foster care or cared for elsewhere or if the mother was no longer in telephone contact during the postnatal period |
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Interventions | Electric pump n = 13 Manual pump n = 12 Usual care (no pump) n = 14 Electric breast pump (Symphony pump, Medela) or manual pump (Harmony pump, Medela, Baar, Switzerland) to use for 10‐14 days. Women were provided with the pump to take home, assistance with the pump in hospital and printed instructions. Women were instructed to pump after 5 nursing sessions for 10 min on each breast every day until their milk came in or until the infant was 5 days old. Women with the manual pump were allowed to keep it, electric pumps were picked up on day 14 postpartum. |
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Outcomes | Women were asked to complete a log of how often they expressed. Other data were collected via telephone. This included a questionnaire pre‐delivery, collecting demographics, the woman’s goal for the duration of breastfeeding, prior experience with breastfeeding and pumping, and participation in the Special Supplemental Nutrition Program for Women, Infant and Children or the Prenatal Care Assistance Program for low‐income women. Women were contacted daily over the 1st 7 days asking questions to determine timing of lactogenesis and feeding methods. At 30 and 90 days postpartum data around infant feeding and breastfeeding support were collected. Successful breastfeeding initiation was defined as breastfeeding on day 4 after delivery. Duration of any breastfeeding was defined as the difference between the infant's date of birth and the last date they were offered the breast. Duration of exclusive breastfeeding was the difference between the infant's date of birth and the first date the infant was offered something other than breast milk. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised at enrolment. Additional information from trial author stated that block randomisation was used (blocks of 10). Blocks were created using a random number table. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not mentioned in report. Correspondence with trial author stated that people recruiting were blinded to group allocation, but that they could not remember where group allocation was kept. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants and lactation consultants was not possible due to the nature of the study. This could have led to performance bias and affected outcomes as breastfeeding measures were self‐reported. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Research assistants collecting data did not know the women's group allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 34/39 women included in the final analysis at 3 months postpartum which was 87% of those enrolled so attrition was < 20%. |
Selective reporting (reporting bias) | Unclear risk | This study was assessed from a published report without access to the protocol, therefore we cannot be certain whether all pre‐specified outcomes were reported. |
Other bias | High risk | Intervention fidelity: all control participants pumped, 1 participant in the electric pump group received no pump, with another declining the pump offered and 2 participants in the manual pump group received an electric pump |