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Trial record 1 of 277 for:    Panama
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Risk of Cesarean Section in Primiparous Women Over 35 Years of Age.

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ClinicalTrials.gov Identifier: NCT03771976
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Brief Summary:
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.

Condition or disease Intervention/treatment
Pregnancy Complications Procedure: Cesarean section Procedure: No cesarean section

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Study Type : Observational
Actual Enrollment : 572 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk of Cesarean Section and Perinatal Complications in Primiparous Women Over 35 Years of Age. A Retrospective Cohort Study.
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : February 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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




Primary Outcome Measures :
  1. Risk of cesarean section [ Time Frame: 5 years ]
    Rate of cesarean sections (birth by cesarean section), independent of the reason.


Secondary Outcome Measures :
  1. Perinatal complications [ Time Frame: 5 years ]
    Any combination of perinatal complications (Stillbirth, low apgar score) between groups.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primiparous women, between 22 and 42 weeks of gestation.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771976


Locations
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Panama
Saint Thomas H
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama

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Responsible Party: Osvaldo A. Reyes T., Chairman of Research - Saint Thomas Maternity Hospital, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT03771976     History of Changes
Other Study ID Numbers: MHST-2014-05
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual data. Just the final results.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Older women (>35 years of age)
Primipara
Cesarean section

Additional relevant MeSH terms:
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Pregnancy Complications