A total of 657 patients (73.7% of eligible patients) completed the 24-month study; the most common reasons for discontinuation from the study were lost to follow-up (11.1%), subject decision (7.0%), and physician decision (5.5%).
During up to one year of follow up, 40 (8%) patients entering the study were lost to follow-up.
The feasibility study outcomes included the proportion of participants who were eligible, willing to be randomised, withdrew from the study, were lost to follow up, and changed model of care (cross-over).
Samples from one study subject consistently showed characteristics of two-site binding and were eventually excluded from the analysis because of difficulties in determining reliable values, and samples from one subject included in the study were lost before measuring affinity.
After we excluded the women who withdrew from the study, were lost to follow-up, or had induced or spontaneous abortions or fetal deaths, 2,506 (95%) women were followed up to delivery (May 2004 August 2008).
After excluding the women who withdrew from the study, were lost to follow-up, with induced or spontaneous abortions or fetal deaths, and with only one valid ultrasound, 1264 (94%) women were followed up to delivery (2003 2008).
First, our sample size was small as approximately 50% of participants with type 2 diabetes either dropped out of the study, were lost to follow-up or died after the baseline assessment.
In 36 cases other patients who were referred for inclusion in the study were lost for a variety of other reasons mainly due to wrong diagnosis (n = 13) or administrative problems with the referral process or at the trial site (n = 15).
Finally, some subjects involved in the present study were lost to follow-up, as is usually the case in cohort studies.
During the study period, no subject was lost to follow-up.
