A Prospective Observational Study of the Performance of Zarin in Kenya

Contraceptive Usage Clinical Trial

Official title:

A Prospective Observational Study of the Performance of Zarin in Kenya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334190
• Other study ID #: 10264
• Status: Completed
• Phase: N/A
• First received: April 11, 2011
• Last updated: July 1, 2013
• Start date: June 2011
• Est. completion date: February 2013

Study information

• Verified date: July 2013
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This will be a non-comparative prospective observational study of women using Zarin as a primary method of contraception in Kenya. It will be conducted in close collaboration with the Kenya MoH in several MoH-affiliated clinics that have experience with implants and sufficient expected flow of implant users per month. The investigators will enroll a total of 600 women divided into two cohorts in this one-year prospective study:

• a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment; and

• a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrollment only if they have complications, medical problems, pregnancy, or want to remove the implant

The main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with Zarin services.

Description:

A non-comparative prospective observational study of women using Zarin as a primary method of contraception in Kenya. It will be conducted in close collaboration with the Kenya MoH in several MoH-affiliated clinics that have experience with implants and sufficient expected flow of implant users per month. The investigators will enroll a total of 600 women divided into two cohorts in this one-year prospective study:

• a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment; and

• a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrollment only if they have complications, medical problems, pregnancy, or want to remove the implant

The main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with Zarin services.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• be aged 18-44 years, inclusive

• be willing to sign an informed consent document

• be willing to give contact information for follow up

• agree to return for follow-up visits

• have decided to receive Zarin as a method of contraception and met the clinic criteria for eligibility of this method of contraception

Study Design

N/A

Related Conditions & MeSH terms

• Contraceptive Usage

Locations

Country	Name	City	State
Kenya	FHI	Nairobi

Sponsors (2)

Lead Sponsor	Collaborator
FHI 360	United States Agency for International Development (USAID)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cumulative probability of pregnancy		1 year	No
Secondary	Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal		1 year	No
Secondary	Prevalence and incidence rate of adverse events		1 year	No
Secondary	The cumulative probability of early discontinuation of Zarin through one year		1 year	No
Secondary	Reasons for discontinuation		1 year	No
Secondary	Level of women's satisfaction with Zarin services		1 year	No