Clinical trial areas
Merged data (n = 117 trials) were analyzed to examine the levels of
trial activity across therapeutic areas. As shown in Figure 3, the
majority of the trials focused on three areas: anesthesia/analgesia (53
trials), anti-infective drugs (including 11 antibiotics; 8 antiviral
agents), endocrine disorders (5 GDM, 5 thyroid dysregulation).
Interestingly, the trials where new drugs were evaluated were focused on
perinatal period: induction and enhancement of parturition (2), PPH (2),
lactation (1), and constipation (1). Trials focusing on pre-eclampsia
and PIH, vomiting, and thyroid autoimmune disease accounted for less
than 4%.
Detailed classification showed that in anesthesia/analgesia, the main
study subjects were analgesia at delivery and prevention of caesarean
section hypotension. In anti-infection, the most common subjects were
antibiotics for gynecological infections and infection prevention for
cesarean surgery. The number of trials in pregnant women with hepatitis
B was the second highest. It is bizarre that there were few studies on
TCM preparations. Only three trials were conducted for adjuvant
treatment of postpartum constipation, postpartum lactation, and
threatened abortion.It is noteworthy that there were 8 prospective
pregnancy registries investigated the pregnancy outcomes following use
of non-recommended medications or contraindicated medications such
ribavirin, type-A toxin, doxycycline, and levofloxacin during and six
months before pregnancy.
Unfortunately, the 5 newly tested drugs were merely the ones being
structurally modified or with change in dosage form based on existing
drugs. A total of 23.8% (21/88) of post-marketing trials evaluated the
use of existing drugs in pregnant women that have not been approved by
the FDA or NMPA for pregnancy use.