Risk of Cesarean Section in Primiparous Women Over 35 Years of Age.

December 11, 2018 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Risk of Cesarean Section and Perinatal Complications in Primiparous Women Over 35 Years of Age. A Retrospective Cohort Study.

The investigators reviewed Saint Thomas Maternity Hospital's database during a 5 year period and compared two cohorts of patients (primiparous women over 35 years of age and primiparous woman between 20 and 34 years of age). The objective was to determine the risk of cesarean section and other perinatal complications between the groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

572

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

  • Panama
      • Panama, Panama
        • Saint Thomas H

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Primiparous women, between 22 and 42 weeks of gestation.

Description

Inclusion Criteria:

  • Pregnant Primiparous women.
  • Birth after 22 weeks and neonatal weight > 501g.

Exclusion Criteria:

  • Multiparity.
  • Birth before 22 weeks or neonatal weight < 500g.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Over 35 years of age
Primiparous women over 35 years of age.
Procedure: Cesarean section
Risk of cesarean section between the cohorts
Procedure: No cesarean section
Vaginal birth rate between the cohorts
Between 20-34 years of age
Primiparous women between 20 and 34 years of age.
Procedure: Cesarean section
Risk of cesarean section between the cohorts
Procedure: No cesarean section
Vaginal birth rate between the cohorts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of cesarean section
Time Frame: 5 years
Rate of cesarean sections (birth by cesarean section), independent of the reason.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perinatal complications
Time Frame: 5 years
Any combination of perinatal complications (Stillbirth, low apgar score) between groups.
5 years

Collaborators and Investigators

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

Sponsor

Saint Thomas Hospital, Panama

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 (Actual)

April 1, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

February 23, 2018

Study Registration Dates

First Submitted

December 9, 2018

First Submitted That Met QC Criteria

December 9, 2018

First Posted (Actual)

December 11, 2018

Study Record Updates

Last Update Posted (Actual)

December 13, 2018

Last Update Submitted That Met QC Criteria

December 11, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHST-2014-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share individual data. Just the final results.

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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