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

Completed

• Conditions: Pregnancy Complications
• Interventions: Procedure: Cesarean section; Procedure: No cesarean section

• Registration Number: NCT03771976
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2018-01-01
• Study Completion: 2018-02-23
• Status Verified: 2018-12
• Study First Submitted: 2018-12-09
• Study First Submitted QC: 2018-12-09
• Study First Posted: 2018-12-11
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 572

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Over 35 years of age	No cesarean section	Primiparous women over 35 years of age.
Over 35 years of age	Cesarean section	Primiparous women over 35 years of age.
Between 20-34 years of age	Cesarean section	Primiparous women between 20 and 34 years of age.
Between 20-34 years of age	No cesarean section	Primiparous women between 20 and 34 years of age.

Primary Outcome Measures

Name	Time	Method
Risk of cesarean section	5 years	Rate of cesarean sections (birth by cesarean section), independent of the reason.

Secondary Outcome Measures

Name	Time	Method
Perinatal complications	5 years	Any combination of perinatal complications (Stillbirth, low apgar score) between groups.

Trial Locations

Locations (1)

Saint Thomas H; 🇵🇦 Panama, Panama