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NCT06184139 Clinical Trial

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

Induction of Labor Affected Fetus / Newborn Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06184139
Other study ID # MISO-LATE_PREG
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2023
Est. completion date January 2024

Study information
Verified date December 2023
Source University of Palermo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 104
Est. completion date January 2024
Est. primary completion date January 2024
Accepts healthy volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Late term pregnancies out of labor, - Bishop score < 7 Exclusion Criteria: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Misoprostol
Oral misoprostol for induction of labor in late term pregnancies

Locations
Country Name City State
Italy Andrea Etrusco Palermo

Sponsors (1)
Lead Sponsor Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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