Effects of maternal obesity on the kinetic disposition of misoprostol during labor inductio

• Conditions: misoprostol; obesity; labor induction; pharmacokinetics; E04.520.252.968

• Registration Number: RBR-7dq3v7b
• Lead Sponsor: Faculdade de Medicina de Ribeirão Preto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-05-01
• Study Start: 2021-08-13
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Female
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>;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<br>

Secondary Outcome Measures

Name	Time	Method
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<br>;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.<br>