Overall findings
As of June 30, 2020, the number of trials registered in the Drug
Clinical Trial Registration and Information Disclosure Platform was
10,856, and the number of trials related to pregnancy drugs was 29
(0.27%), of which only 6 trials recruited pregnant or parturient women.
These trials included phase II and phase III, and the effectiveness and
safety of these drugs for the mother were the endpoints. There were no
pre-planned pharmacokinetic assays. The other 23 clinical trials where
the investigational drugs’ indications included pregnancy related
diseases, but did not enroll any pregnant women. Interestingly, most of
them (18/23) were bioequivalence (BE) test and human pharmacokinetic
test. There were 2 trials set the maternal or fetal outcomes as the
primary endpoint. All trials on this platform used randomized parallel
or cross-over grouping design. The number of trials registered in the
”ChiCTR” was 33,649, and the number of trials enrolling pregnant women
was 88 (0.26%). All of them were post-marketing studies, including
observational studies or interventional studies. Of the 88 studies,
63.6% (56/88) were randomized parallel controls, 17.0% (15/88) were
cohort studies, 4 studies were cross-sectional designs, and 14.7%
(13/88) did not indicate randomization. Of these trials, 77.3% (68/88)
set both maternal and fetal outcomes as the primary endpoint.Annual
numbers of pregnant drug clinical trials by study phase from those two
registered platforms were shown in figure 2.