Introduction: It is unclear whether falling insulin requirements (FIR), in late pregnancy, are a sign of placental dysfunction.
Objective: To investigate the association of FIR with maternal biomarkers and adverse obstetric outcomes, amongst women with pre-existing diabetes in pregnancy.
Methods: A multicentre prospective cohort study, including 41 women with Type 1 and 117 with Type 2 diabetes, was conducted. Women with FIR of ≥15% from the peak total daily dose after 20 weeks gestation, were considered cases (n=32). The primary outcome was a composite of clinical markers of placental dysfunction (pre-eclampsia, small for gestational age (<5%), stillbirth (>20 weeks), premature delivery (<30 weeks) and placental abruption). Maternal circulating angiogenic markers (placental growth factor (PlGF), soluble fms-like tyrosine kinase 1 (sFlt-1), placental hormones (human placental lactogen, progesterone, TNF-α) and HbA1c were studied serially during pregnancy.
Results: FIR ≥15% was associated with an increased risk of the composite primary outcome (OR:4.38,CI 1.9-10.3,p<0.001), pre-eclampsia (OR:6.76,CI 2.7-16.7,p<0.001) and was more common amongst women with type 1 diabetes (36.6 vs. 14.5%,p=0.002). There was no difference in HbA1c between groups. The ratio of sFlt-1:PlGF was significantly higher amongst women with FIR at 25, 30 and 36wks (p<0.01). To account for the effect of pre-eclampsia, the cohort was divided into subgroups: no pre-eclampsia and no FIR (1), no pre-eclampsia and FIR (2), pre-eclampsia and no FIR (3) and pre-eclampsia and FIR (4). There was a significant correlation between increasing sFlt-1:PlGF levels at 36 weeks as the subgroups increased from 1-4 respectively suggesting increasing underlying placental dysfunction (r=0.357,p<0.001). There was no difference in placental hormones between the groups.
Conclusion: This is the first prospective study to associate FIR with altered expression of placental anti-angiogenic factors and pre-eclampsia. FIR is an important clinical sign, amongst women with pre-existing diabetes, which should alert the clinician to investigate underlying placental dysfunction.