Effect of Maternal Age and BMI on Induction of Labor Using Oral Misoprostol in Late-term Pregnancies: a Retrospective Cross-sectional Study

NCT06184139 | Unknown

• 1 other identifier: MISO-LATE_PREG
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of maternal age and body mass index (BMI) on oral misoprostol induction of labor for late-term pregnancies.

Conditions

Induction of Labor Affected Fetus / Newborn; Pregnancy Late

Keywords

Late-term pregnancy; body mass index; age; oral misoprostol; cervical ripening; induction of labor

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of misoprostol for induction of labor

  Efficacy induction of labor for late term pregnancies according to age and BMI

  290 days of pregnancy

Interventions

Misoprostol DRUG

Oral misoprostol for induction of labor in late term pregnancies

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

term (37 weeks or more of gestation) singleton pregnancies in women who have not had a previous cesarean delivery and a bishop score \< 7.

You may qualify if:

• Late term pregnancies out of labor,
• Bishop score \< 7

You may not qualify if:

• labor (defined as presence of at least three painful uterine contractions every ten minutes),
• uterine tachysystole (\>5 contractions within 10 minutes for two consecutive 10-minute periods),
• hypertonic uterus,
• abnormal CTG,
• contraindications to vaginal delivery (fetal malpresentation such as breech presentation or transverse situation, fetal macrosomia, abnormally implanted placenta, active genital herpes infection, cervical cancer),
• patients with parity \> 4,
• medical contraindication to misoprostol (asthma, glaucoma),
• women with previous hysterotomies.

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

Andrea Etrusco

Palermo, 90123, Italy

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: December 28, 2023
• Study Start: December 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

IT (1)