Comparison of levonorgestrel level and creamatocrit in milk following immediate versus delayed postpartum placement of the levonorgestrel IUD

Niaree G Hopelian,Rebecca G Simmons,Eve Espey,Sabrina Malone Jenkins,Jessica N Sanders,Katherine Ward,David K Turok

doi:10.1186/s12905-021-01179-7

Abstract

BackgroundBreastfeeding and postpartum contraception critically influence infant and maternal health outcomes. In this pilot study, we explore the effects of timing and duration of postpartum levonorgestrel exposure on milk lipid and levonorgestrel content to establish baseline data for future research.MethodsThis sub-study recruited a balanced convenience sample from 259 participants enrolled in a parent randomized controlled trial comparing immediate to delayed (4–8 weeks) postpartum levonorgestrel IUD placement. All planned to breastfeed, self-selected for sub-study participation, and provided the first sample at 4–8 weeks postpartum (before IUD placement for the delayed group) and the second four weeks later. We used the Wilcoxon rank sum (inter-group) and signed rank (intra-group) tests to compare milk lipid content (creamatocrit) and levonorgestrel levels between groups and time points.ResultsWe recruited 15 participants from the immediate group and 17 from the delayed group with 10 and 12, respectively, providing both early and late samples. Initially, median levonorgestrel concentration of the immediate group (n = 10) (32.5 pg/mL, IQR: 24.8, 59.4) exceeded that of the delayed group (n = 12) (17.5 pg/mL, IQR: 0.0, 25.8) (p = 0.01). Four weeks later, the values aligned: 26.2 pg/mL (IQR: 20.3, 37.3) vs. 28.0 pg/mL (IQR: 25.2, 40.8). Creamatocrits were similar between both groups and timepoints.ConclusionsImmediate postpartum levonorgestrel IUD placement results in steady, low levels of levonorgestrel in milk without apparent effects on lipid content. These findings provide initial support for the safety of immediate postpartum levonorgestrel IUD initiation, though the study was not powered to detect noninferiority between groups.Trial Registration: This randomized controlled trial was registered with ClinicalTrials.gov (Registry No. NCT01990703) on November 21, 2013.

Highlights

Breastfeeding and postpartum contraception critically influence infant and maternal health outcomes
Using an enzyme-linked immunoassay for levonorgestrel and traditional creamatocrit measurements, we sought exploratory data to assess differences in milk levonorgestrel and lipid content over time to provide point estimates for future research on exogenous progestogen and creamatocrit lipid levels among women receiving an early versus delayed postpartum levonorgestrel intrauterine device (IUD). Design This nested, prospective, longitudinal sub-study is an exploratory secondary analysis derived from the Breastfeeding Levonorgestrel IUD Study (BLIS) randomized controlled noninferiority trial
We found that women receiving delayed IUD placement eventually have similar levonorgestrel milk levels and similar milk lipid content compared to those receiving immediate postpartum IUD placement

Summary

Introduction

Breastfeeding and postpartum contraception critically influence infant and maternal health outcomes. In this pilot study, we explore the effects of timing and duration of postpartum levonorgestrel exposure on milk lipid and levonorgestrel content to establish baseline data for future research. We explore the effects of timing and duration of postpartum levonorgestrel exposure on milk lipid and levonorgestrel content to establish baseline data for future research Both breastfeeding and the use of postpartum contraception critically influence infant and maternal health outcomes [1, 2]. Our pilot research represents the first comparative clinical trial assessing variable timing of levonorgestrel exposure in human milk using this EIA kit

Methods

Results

Conclusion