Contraception Clinical Trial
Official title:
Immediate Post-partum Initiation of Etonogestrel-releasing Implant: a Randomized Controlled Trial on Breastfeeding Impact
The etonogestrel (ENG) implant inserted immediately postpartum reduces the risk of pregnancy recurrence, especially in vulnerable populations. A limitation to recommending this practice universally is the low quality of evidence on the effect of the ENG implant on breastfeeding when inserted immediately postpartum. This study is the first assessing the impact of inserting the ENG implant immediately postpartum on the amount of milk using the gold standard method for this purpose.
What is known already: The ENG implant inserted immediately postpartum reduces the risk of
pregnancy recurrence, especially in vulnerable populations. A limitation to recommending
this practice universally is the low quality of evidence on the effect of the ENG implant on
breastfeeding when inserted immediately postpartum. This study is the first assessing the
impact of inserting the ENG implant immediately postpartum on the amount of milk using the
gold standard method for this purpose.
Study design, size, duration: This randomized, single-blind and controlled clinical trial
evaluated 24 postpartum women and their NBs and was conducted at the Women's Health
Reference Center of Ribeirão Preto, Brazil. The mother-NB pairs were evaluated for six weeks
postpartum.
Participants/materials, setting, methods: Twenty-four mother-NB pairs were randomized into
two groups: a) Implant group: ENG-releasing implant inserted within 48 h after delivery and
b) Control group: absence of contraceptive method for six weeks after delivery.
Anthropometric assessments and breastfeeding questionnaires were conducted at 4-time points
of the 6-week monitoring period (at study admission and on the 14th, 29th and 43rd days
after randomization). Saliva samples were collected from the mother-NB pairs prior to
deuterium (D2O) dose administration. Totals of 5 g and 10 g D2O were orally administered to
the postpartum women on the day of randomization (day 0) and the 29th study day,
respectively. New saliva samples were collected on days 1, 2, 3, 4, 13 and 14 following
intake of each D2O dose. The D2O isotope ratio was assessed in saliva samples using mass
spectrometry to estimate the volume of breast milk ingested by the NB (daily average
expressed as mL/day).
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
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