Effects of Three Methods of Breast Milk Expression on Breastfeeding Initiation, Breast Milk Extraction and Proportion of Exclusive Breastfeeding: An Open Label, Randomized Controlled Trial

Abstract

Background: Direct breastfeeding hasmultiple health benefits. However, some mothers may not be able to bring their infants to breast feeding directly in a timely way. In this situation, to provide their infants with breast milk, mothers usually express their breasts. However there is insufficient evidence regarding an effective method of breast milk expression in the absence of an infant's suction. 

Objectives: To investigate the effects of different methods of breast milk expression on breastfeeding initiation, efficacy of breast milk extraction, and as a consequence, on the rate of exclusive breastfeeding at 6 months.  Study design In this open-label, randomized controlled trial, the participants of mother-infant dyads separated immediately after birth for at least 6 hrs were recruited and randomly assigned (1:1:1) into three groups: (1) hand expression of breast milk; (2) sequential electrical breast pumping: and (3) simultaneous electrical breast pumping. Hand pumping or electrical breast pumping was initiated 2 hours postpartum in the absence of infants' suction. The two primary outcome measures were the time required for initiation of breastfeeding and the milk volume expressed in a 10-minute session (direct breastfeeding in hand expression group) at 3 days and at 6 weeks; a secondary outcome was the proportion of exclusive breastfeeding at 4 and 6 months. Analysis was according to intention-to-treat.

Findings: Between Apr 2018 and Jan 2019, we recruited 226 participants, of whom 154 were randomized. The time to breastfeeding initiation showed no difference between the three groups. At 3 days and at 6 weeks, the volume of breast milk produced by 10 minutes of sequential pumping or simultaneous pumping was less than that of hand pumping before direct breastfeeding, while the volume did not differ significantly between the two pumping groups. However, simultaneous breast pumping was more effective than sequential pumping both in volume and saving time in women who had established breastfeeding. The time required to initiate breastfeeding was inversely associated with the volume of pumped breast milk at 6 weeks. The rate of exclusive breastfeeding at 4 months was 21·0%, and at 6 months 10·6%, and did not differ between the three methods of breast milk expression. No serious adverse events were observed. 

Interpretation:  Hand expression, sequential breast pumping, or simultaneous breast pumping in absence of immediate infant suction after birth did not show differences on the time required to initiate breastfeeding, or on the rate of exclusive breastfeeding at 4 and 6 months. However, simultaneous pumping was more effective in breast milk extraction than sequential pumping in women who established breastfeeding.

Trial Registration: This now-completed trial was registered with  www.chictr.org.cn (ChiCTR1800018193). 

Funding Statement: This study was supported in part by funds granted to Lin Zhang from: the Shanghai Hospital development center (SHDC12016204), the Xinhua Hospital Fund (XHYJ170029), and the Shanghai Municipal Health Commission (201640032). Philips Invest (China) Co. Ltd. provided the breast pumps and pilot study data on breast milk volume difference for sample size estimation.

Declaration of Interests: Authors declare no competing interests.

Ethics Approval Statement: Ethical approval of this trial was obtained from the Institutional Review Board of Shanghai Jiaotong University School of Medicine. All participants provided written informed consent before any trial-related procedures.