A Drug Utilisation Surveillance Study to Assess the Clinical Utility and Safety of Oral Natural Micronized Progesterone SR in High Risk Pregnancies: NAP-DELAY Study QC04-QC06
Dr. Krishnaprasad Korukonda,
A-401, Gurudev Apartments, Rc Marg Chembur, Mumbai-400071, Maharashtra, India.
Introduction: High risk pregnancy represents a clinical enigma with several management strategies suggested as prophylaxis or therapeutic approach. In most cases of women with Unexplained Bad Obstetric History (BOH) or Preterm Birth (PTB), luteal phase insufficiency has often been suggested as the underlying cause that may require long-term administration of progesterone. Natural progesterone offers complimentary anti-inflammatory, immunomodulatory and uterine quiescence actions that go a long way in continuing pregnancy till term while avoiding complications of preterm delivery or infant mortality.
Aim: To understand the clinical efficacy and safety of Natural progesterone as primary or secondary prophylactic strategy for High risk women with risk factors for PTB or BOH.
Materials and Methods: Retrospective, case cohort analyses of Natural progesterone prescriptions utilising the Drug utilisation surveillance sheet were carried out at 40 centres across India between July and October’16. Descriptive statistics was utilised to describe the numerical and categorical (nominal and continuous) data.
Results: Consecutive prescription records of 185 patients with High risk pregnancy were available for analyses. Baseline demographics included mean age of 28.4 yrs, body weight 60.5 kg with mean abortion rate of 1.5 and 2 for BOH women with first or second trimester loss. Natural progesterone as OMP SR was supplemented for PTB prophylaxisin BOH cases with first or second trimester loss cases, Cervical factor, Still birth, Spotting and Placenta previa. The preferred dosage of OMP SR for women with Cervical factor, First or Second trimester loss was 300 mg for mean duration of 19, 16 and 21 weeks respectively. Similarly in the unexplained Recurrent Pregnancy Loss (RPL) cases, OMP SR was administered in mean dosage of 271mg for 18±5 weeks to prevent pregnancy loss. In all cases, pregnancy was continued till 34th week with no adverse health outcome. Common adverse events including gastritis (n=4, 2.2%), vomiting (n=4, 2.2%), drowsiness (n=8, 4.3%), dizziness (n=6, 3.2%), spotting (n=2, 1.1%), and treated symptomatically with none requiring further hospitalisation or referral.
Conclusion: Clinical supplementation with oral NMP SR suggests therapeutic compliance and safety profile for long-term administration especially in High risk pregnancies involving unexplained BOH or PTB risk.