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

December 14, 2023 updated by: Andrea Etrusco, University of Palermo
To evaluate the effect of maternal age and body mass index (BMI) on oral misoprostol induction of labor for late-term pregnancies.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy, 90123
        • Andrea Etrusco
        • Principal Investigator:
          • Andrea Etrusco, M.D.
        • Contact:
          • Andrea Etrusco, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of misoprostol for induction of labor
Time Frame: 290 days of pregnancy
Efficacy induction of labor for late term pregnancies according to age and BMI
290 days of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Palermo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

November 18, 2023

First Submitted That Met QC Criteria

December 14, 2023

First Posted (Actual)

December 28, 2023

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISO-LATE_PREG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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