Risk of Cesarean Section in Primiparous Women Over 35 Yea... | NCT03771976

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

NCT03771976

Sponsor

Saint Thomas Hospital, Panama

Status

Completed

Last Update Posted

Dec 13, 2018Actual

Enrollment

572Actual

Phase

Not provided

Conditions

Pregnancy Complications

Interventions

Cesarean section
No cesarean section

Countries

Panama

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

Jan 1, 2018Actual

Completion Date

Feb 23, 2018Actual

First Submitted Date

Dec 9, 2018

First Submission Date that Met QC Criteria

Dec 9, 2018

First Posted Date

Dec 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2018

Last Update Posted Date

Dec 13, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Osvaldo A. Reyes T., Chairman of Research - Saint Thomas Maternity Hospital, Saint Thomas Hospital, PanamaPrincipal Investigator

Lead Sponsor

Saint Thomas Hospital, PanamaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

572Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Over 35 years of age		Primiparous women over 35 years of age.	Procedure: Cesarean section Procedure: No cesarean section
Between 20-34 years of age		Primiparous women between 20 and 34 years of age.	Procedure: Cesarean section Procedure: No cesarean section

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cesarean section	Procedure	Risk of cesarean section between the cohorts	Between 20-34 years of age Over 35 years of age

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Primiparous women, between 22 and 42 weeks of gestation.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011248	Pregnancy Complications

Ancestor Terms

ID	Term
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002585	Cesarean Section

Ancestor Terms

ID	Term
D036861	Delivery, Obstetric
D013513	Obstetric Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided