Association of Implementation of a Comprehensive Preconception-to-Pregnancy Management Plan With Pregnancy Outcomes Among Chinese Pregnant Women With Type 1 Diabetes: The CARNATION Study
Research Design and Methods A comprehensive preconception-to-pregnancy management plan for women with T1D was implemented in 11 centers from eight Chinese cities during 2015–2017. Sequential eligible pregnant women (n=133 out of 137 initially enrolled) with T1D and singleton pregnancies attending these management centers formed the prospective cohort. The main outcome was severe adverse pregnancy outcome comprising maternal mortality, neonatal death, congenital malformation(s), miscarriage in the second trimester and stillbirth. We compared pregnancy outcomes in this prospective cohort with two control groups with the same inclusion and exclusion criteria: a retrospective cohort (n=153) of all eligible pregnant women with T1D attending the same management centers during 2012–2014 and a comparison cohort (n=116) of all eligible pregnant women with T1D receiving routine care during 2015–2017 in 11 different centers from seven cities.
Results The rate of severe adverse pregnancy outcome was lower in the prospective cohort (6.02%) than in either the retrospective cohort (18.30%, adjusted odds ratio[aOR]=0.31, 95% CI 0.13–0.74) or the contemporaneous comparison cohort (25.00%, aOR=0.22, 95% CI 0.09–0.52).
Conclusion The substantial improvements in the prospective cohort are evidence of a potentially clinically important effect of the comprehensive management plan on pregnancy outcomes among Chinese pregnant women with pregestational T1D. This supports the development of similar approaches in other countries.