check_circleStudy 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 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.

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

StatusInstitutionLocation
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
    date_rangeTime 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
    date_rangeTime 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