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Not yet recruitingNCT06184139Updated Dec 28, 2023

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

An observational study in Induction of Labor Affected Fetus / Newborn and Pregnancy Late, sponsored by University of Palermo. Not yet recruiting at 1 site in Italy. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-12-28.

Sponsored by University of Palermo · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
104
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Induction of Labor Affected Fetus / Newborn
  • Pregnancy Late

Keywords

  • Late-term pregnancy
  • body mass index
  • age
  • oral misoprostol
  • cervical ripening
  • induction of labor
03

In context

Lead sponsor

University of Palermo is the lead sponsor of 142 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
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.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
104 participants (estimated)
Patient registry
No

Interventions

  • DrugMisoprostol

    Oral misoprostol for induction of labor in late term pregnancies

06

What researchers measure

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

    Time frame: 290 days of pregnancy

07

Study locations

1 site
  • Andrea Etrusco
    Palermo, 90123, Italy
    • Andrea Etrusco, M.D. · Contact
    • Andrea Etrusco, M.D. · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06184139
Lead sponsor
University of Palermo
Responsible party
Andrea Etrusco (Principal investigator, University of Palermo) — Principal investigator
First posted
Dec 28, 2023
Start date
Dec 2023 (estimated)
Primary completion
Jan 2024 (estimated)
Completion
Jan 2024 (estimated)
Last update
Dec 28, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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