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

Pregnancy Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771976
• Other study ID #: MHST-2014-05
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: February 23, 2018

Study information

• Verified date: December 2018
• Source: Saint Thomas Hospital, Panama
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 572
• Est. completion date: February 23, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant Primiparous women.

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

Exclusion Criteria:

• Multiparity.

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

Related Conditions & MeSH terms

• Pregnancy Complications

Intervention

Procedure:
• Cesarean section
Risk of cesarean section between the cohorts
• No cesarean section
Vaginal birth rate between the cohorts

Locations

Country	Name	City	State
Panama	Saint Thomas H	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of cesarean section	Rate of cesarean sections (birth by cesarean section), independent of the reason.	5 years
Secondary	Perinatal complications	Any combination of perinatal complications (Stillbirth, low apgar score) between groups.	5 years