NCT03771976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
572

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

9 months

First QC Date

December 9, 2018

Last Update Submit

December 11, 2018

Conditions

Pregnancy Complications

Keywords

Older women (>35 years of age)PrimiparaCesarean section

Outcome Measures

Primary Outcomes (1)

  • Risk of cesarean section

    Rate of cesarean sections (birth by cesarean section), independent of the reason.

    5 years

Secondary Outcomes (1)

  • Perinatal complications

    5 years

Study Arms (2)

Over 35 years of age

Primiparous women over 35 years of age.

Procedure: Cesarean sectionProcedure: No cesarean section

Between 20-34 years of age

Primiparous women between 20 and 34 years of age.

Procedure: Cesarean sectionProcedure: No cesarean section

Interventions

Cesarean sectionPROCEDURE

Risk of cesarean section between the cohorts

Between 20-34 years of ageOver 35 years of age
No cesarean sectionPROCEDURE

Vaginal birth rate between the cohorts

Between 20-34 years of ageOver 35 years of age

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primiparous women, between 22 and 42 weeks of gestation.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas H

Panama City, Panama

Location

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Research - Saint Thomas Maternity Hospital

Study Record Dates

First Submitted

December 9, 2018

First Posted

December 11, 2018

Study Start

April 1, 2017

Primary Completion

January 1, 2018

Study Completion

February 23, 2018

Last Updated

December 13, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

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

Locations

PA(1)