Abstract
The objective of the study was to evaluate safety to infants whose mothers used Norplant
levonorgestrel implants during breastfeeding. A nonrandomized clinical trial design
was used. Participants were 220 and 222 healthy breastfed infants of mothers initiating
use of Norplant or T-Cu IUD, respectively, at 55 days to 60 days postpartum. Infants
were followed from birth through age 6 years. Breastfeeding pattern, infant growth,
and disease events were recorded monthly in the first year, three-monthly in the second,
and annually thereafter.
Most mothers continued use of Norplant (96.4%) and T-Cu (94.1%) during lactation,
and 2140 months of infant exposure to levonorgestrel were accumulated. Breastfeeding
pattern and infants growth, from admission through age 6 years, were similar in both
groups. In the first year, breastfed infants in the Norplant group had higher incidence
rates (p < 0.05) of mild episodes of respiratory infections (adjusted RR 1.17, CI
1.08–1.27), skin conditions (adjusted RR 1.46, CI 1.20–1.79), and eye infections (unadjusted
RR 1.49, CI 1.03–2.18) than the control group. Later on, a higher proportion of infants
in the T-Cu group showed neurological conditions.
Although breastfeeding patterns and infant growth is not affected by Norplant use
during lactation, the effect on infants’ health of steroidal contraception should
be further evaluated.
Keywords
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Article info
Publication history
Accepted:
March 12,
2002
Received in revised form:
December 20,
2001
Received:
January 2,
2001
Footnotes
☆This investigation received financial support from the UNDP/UNFPA/WHO/World Bank, Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization.
Identification
Copyright
© 2002 Elsevier Science Inc. Published by Elsevier Inc. All rights reserved.
