Developing New Pharmaceutical Treatments for Obstetric Conditions Flashcards
Roughly what proportion of the global burden of disease is made up of maternal and perinatal disease?
7%
Which cancers have increased likelihood in the children of women who took diethylstilboestrol for prevention of early miscarriage? (2 of them)
- Clear cell adenocarcinoma of the vagina and cervix
- Breast cancer
What uses has Thalidomide been repurposed for?
Pain relief in leprosy and Kaposi sarcoma
What is the mechanism and timing of teratogenicity due to isotretinoin?
Inhibition of migration of cranial neural crest cells if taking before 28 days’ gestation
Why do immunoglobulins cross the human placenta but not that of other mammals?
The human placenta is monochorial.
(other mammals have multiple cell layers between maternal and fetal circulation)
What is evaluated in phase 1 trials?
determining safety, safe dosage range and identifying side effects
What is evaluated in phase 2 trials?
Evaluate safety and begin to determine efficacy
What is evaluated in phase 4 trials?
Delineate additional information such as treatment risks, benefits and optimal use
What is evaluated in phase 3 trials?
Comparison to existing treatments
Why do the RCOG guidelines state that it is reasonable not to use tocolysis?
There are no trials demonstrating long term benefits of delaying delivery in preterm labour