misoprostol
Conditions
Interventions
We investigated 40 pregnant women who were recruited at the Women's Health Reference Center (MATER) and at the Hospital das Clínicas of the Ribeirão Preto Medical School (HCFMRP-USP) who had an indica
Sponsors
Faculdade de Medicina de Ribeirão Preto
Faculdade de Ciências Farmacêuticas de Ribeirão Preto
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Parturients (> 18 years old); single pregnancy; BMI characterized as: not obese, obese grade 1, obese grade 2 and morbid obesity; without fetal complications; hospitalized for induction of labor with misoprostol 25ug vaginally.
Exclusion criteria
Exclusion criteria: patients with renal failure and chronic liver diseases (identified by laboratory tests); congestive heart failure; patients who suffered a heart attack or stroke less than six months ago; patients with a history of severe chronic obstructive pulmonary disease; parturients who used inducers or inhibitors CYP; previous cesarean section
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The method of analysis of misoprostol in plasma, using UPLC-MS / MS presented limits of quantification compatible with the application in pharmacokinetic studies and analysis up to 6 hours after the administration of 25 µg of misoprostol via vaginal ;There was no difference between groups regarding pharmacokinetic parameters, so BMI is not the main characteristic to analyze when inducing labor. Weight is the most robust variable, as it influences the AUC of misoprostolic acid. | — |
Primary
| Measure | Time frame |
|---|---|
| Check whether obesity influences the drug's bioavailability (AUC), suggesting that the dose regimen of misoprostol should be changed from 25 µg to 50 µg, vaginally, in obese patients. ;Obesity influenced the rate of failure of induction, the higher the BMI, the greater the rate of failure of induction, the greater the length of hospital stay, the greater the number of pills used | — |
Countries
Brazil
Contacts
Public ContactRicardo Cavalli
Outcome results
None listed