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.