Study Completed

Female contraception

Bayer Identifier:

18561

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

Trend and regional variations of contraception measures

Trial purpose

The study was a retrospective observational study that assessed the percentage of reproductive women (aged 15 to 44 years) using contraception by US geographic regions and industry sections between 2005 and 2014. Methods of contraception included most and moderately effective FDA-approved methods of contraception (i.e. female sterilization, IUD/IUS, hormonal implant, injectable, oral contraceptive pills, patch, vaginal ring, diaphragm) and long-acting reversible contraception methods (LARC; i.e., IUD/IUS, or hormonal implant). Around 44 million datasets were retrieved from the Truven Health MarketScan® Commercial Claims and Encounters database and used to calculate two experimental assessment measures UCM (Use of Contraceptive Methods) and PCU (Postpartum Contraceptive Use), both proposed by the Office of Population Affairs of the US Centers for Disease Control and Prevention. The study showed an increasing utilization of contraception in the commercial sector, albeit with age group and regional variations.

Key Participants Requirements

Sex

Female

Age

15 - 44 Years

Inclusion Criteria
Inclusion criteria for the overall population

1. Women of reproductive age (i.e., ages 15 – 44) who were not pregnant at any
point in the measurement year.
2. Women who were pregnant at some point in the measurement year and ended in
a known miscarriage, ectopic pregnancy, stillbirth, or induced abortion.
3. Women who were pregnant and ended in a live birth delivery in the first 10 months
of the measurement year, since there was adequate time to provide contraception
in the postpartum period.

Inclusion criteria for the postpartum population

1. All women of reproductive age (i.e., ages 15 – 44) with a live birth delivery.

Exclusion criteria for the overall population

1. Women who were infecund due to non-contraceptive reasons such as natural
menopause or oophorectomy anytime during the calendar year. If subjects were
continuously enrolled for more than one calendar year, they were excluded from
all subsequent years if they were determined to be infecund due to non-
contraceptive reasons anytime during a particular calendar year.
2. Women who gave birth in the last two months of the measurement year because
there may not have been an opportunity to provide them with contraception.
3. All women who were pregnant at some point in the measurement year who were
either still pregnant at the end of the year, or because the outcome of the
pregnancy was unknown.

Exclusion criteria for the postpartum population

1. Women without continuous enrollment for 60 days after a live birth.
2. Women with deliveries that did not end in a live birth (i.e., miscarriage, ectopic,
stillbirth, or pregnancy termination) .
3. Women with deliveries that occurred during the last 2 months of the measurement
year.
Exclusion Criteria

Trial summary

Enrollment Goal

44250680

Trial Dates

October 2015 - March 2016

Phase

N/A

Could I Receive a placebo

N/A

Products

Unspecified

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		many locations, United States

Primary Outcome

UCM
Percentage of reproductive women aged 15 to 20 years and 21 to 44 years using either most or moderately effective FDA-approved methods of contraception or long-acting reversible method of contraception (LARC) by year, US geographic region and commercial sector
Time Frame:
10 years
PCU
Percentage of reproductive women aged 15 to 20 years and 21 to 44 years with a recent life birth and using either most or moderately effective FDA-approved methods of contraception or long-acting reversible method of contraception (LARC) by year, US geographic region and commercial sector
Time Frame:
10 years

Trial design

Retrospective Claims Analysis to Examine the Trend and Regional and Industry Type Variations of Proposed Contraception Measures in a Commercially Insured Population

Trial Type

Observational

Intervention Type

N/A

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.10-Aug-2016; AY