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Unintended PregnancyNCT01986439

The Contraceptive Choice Project

An observational study of Unintended Pregnancy and Teen Births, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this project is to remove barriers to obtaining contraceptive methods, including the most effective and expensive methods. The study seeks to remove the financial and knowledge barriers and promote the most effective contraceptive methods to reduce unintended pregnancy rates at the population level. Read more about this study

Who is it for?
Ages 14 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Unintended Pregnancy, Teen Births, Abortion
How many people
9,256 participants
Where
1 siteUnited States
Study dates
Aug 2007to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Study population: Women of reproductive age who reside in the St. Louis metropolitan region.

Who may be able to join

  • 14-45 years of age
  • Primary residency in St. Louis City or County
  • Does not desire pregnancy during the next 1 year
  • Desires reversible contraception
  • Sexually active with a man within the past 6 months or intend to have sex with a man in the next 6 months
  • Is not currently using a contraceptive method, has begun using a new contraceptive method within the last 4 weeks, or is a current contraceptive method user who wants to switch to a NEW contraceptive method immediately
Show all 12Show fewer
  • Willing and able to undergo informed consent
  • Willing to comply with study protocol and 2-year follow-up schedule
  • Not currently pregnant, or meets one of the following criteria:
  • Currently pregnant, undergoing medical or surgical termination of pregnancy, and planning for post-abortion contraception
  • Currently pregnant with an abnormal pregnancy (miscarriage or ectopic pregnancy), undergoing medical or surgical management, and planning for post-pregnancy contraception
  • Currently pregnant, estimated gestational age of 36 weeks or greater, and planning for post-partum contraception.

Who cannot join

  • History of hysterectomy or sterilization
  • Current participation in another research study that would interfere with the conduct of this study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University in St. Louis School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

The purpose of this project is to remove barriers to obtaining contraceptive methods, including the most effective and expensive methods. The study seeks to remove the financial and knowledge barriers and promote the most effective contraceptive methods to reduce unintended pregnancy rates at the population level.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distribution of contraceptive method chosen

    Distribution of methods (%) chosen at baseline enrollment, by method and stratified by Long-Acting Reversible Contraception (LARC: intrauterine device and implant) and non-LARC (depotmedroxyprogesterone acetate (DMPA), oral contraceptive pill (OCP), vaginal ring, transdermal patch).

    Measured: Baseline

Secondary outcomes (5)

  1. Method Continuation

    % of women using each method at 6, 12-, 24, and 36 months post-enrollment. Hazard rates via survival analysis comparing LARC and non-LARC methods.

    Measured: 6-month, 12 month, 24-month, and 36-month

  2. Method Satisfaction

    % of women very or somewhat satisfied with method at 12, 24, and 36 months of use. Comparison of all methods and stratified by LARC and non-LARC methods.

    Measured: 12-month, 24-month, 36-month

  3. Teen Pregnancy Rates

    Number of pregnancies per participants 15-19 years of age. We will calculate an annual rate for each year from 2007-2013 and also calculate a rate for the cohort followed for 1 year, 2 years, and 3 years.

    Measured: 1-year, 2-year, 3-year

  4. Repeat Abortion Rates

    Number of abortions among participants 15-44 with a history of abortion. We will calculate an annual rate for each year from 2007-2013 and also calculate a rate for the cohort followed for 1 year, 2 years, and 3 years.

    Measured: 1-year, 2-year, 3-year

  5. Sexually transmitted infection rates

    Baseline prevalence rates (number positive divided by number tested) for chlamydia, gonorrhea, and trichomonas. 1-year incidence rates for the same infections among those who tested at 1-year.

    Measured: Baseline and 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2013 (estimated)
  2. Study startAug 2007
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
9,256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01986439
Sponsor's protocol ID
201101982
Status last verified
Apr 2015
First submitted
31 Oct 2013
Last updated
14 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Tepe M, Mestad R, Secura G, Allsworth JE, Madden T, Peipert JF. Association between tampon use and choosing the contraceptive vaginal ring. Obstet Gynecol. 2010 Apr;115(4):735-739. doi: 10.1097/AOG.0b013e3181d41c4a.

    PubMed 20308832

  • Secura GM, Allsworth JE, Madden T, Mullersman JL, Peipert JF. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010 Aug;203(2):115.e1-7. doi: 10.1016/j.ajog.2010.04.017. Epub 2010 Jun 11.

    PubMed 20541171

  • Spain JE, Peipert JF, Madden T, Allsworth JE, Secura GM. The Contraceptive CHOICE Project: recruiting women at highest risk for unintended pregnancy and sexually transmitted infection. J Womens Health (Larchmt). 2010 Dec;19(12):2233-8. doi: 10.1089/jwh.2010.2146. Epub 2010 Sep 11.

    PubMed 20831439

  • Pittman ME, Secura GM, Allsworth JE, Homco JB, Madden T, Peipert JF. Understanding prescription adherence: pharmacy claims data from the Contraceptive CHOICE Project. Contraception. 2011 Apr;83(4):340-5. doi: 10.1016/j.contraception.2010.08.003. Epub 2010 Sep 17.

    PubMed 21397092

  • Peipert JF, Zhao Q, Allsworth JE, Petrosky E, Madden T, Eisenberg D, Secura G. Continuation and satisfaction of reversible contraception. Obstet Gynecol. 2011 May;117(5):1105-1113. doi: 10.1097/AOG.0b013e31821188ad.

    PubMed 21508749

  • Kittur ND, Secura GM, Peipert JF, Madden T, Finer LB, Allsworth JE. Comparison of contraceptive use between the Contraceptive CHOICE Project and state and national data. Contraception. 2011 May;83(5):479-85. doi: 10.1016/j.contraception.2010.10.001. Epub 2010 Nov 23.

    PubMed 21477693

  • Kossler K, Kuroki LM, Allsworth JE, Secura GM, Roehl KA, Peipert JF. Perceived racial, socioeconomic and gender discrimination and its impact on contraceptive choice. Contraception. 2011 Sep;84(3):273-9. doi: 10.1016/j.contraception.2011.01.004. Epub 2011 Feb 21.

    PubMed 21843693

  • Mestad R, Secura G, Allsworth JE, Madden T, Zhao Q, Peipert JF. Acceptance of long-acting reversible contraceptive methods by adolescent participants in the Contraceptive CHOICE Project. Contraception. 2011 Nov;84(5):493-8. doi: 10.1016/j.contraception.2011.03.001. Epub 2011 Apr 27.

    PubMed 22018123

  • Graseck AS, Secura GM, Allsworth JE, Madden T, Peipert JF. Home screening compared with clinic-based screening for sexually transmitted infections. Obstet Gynecol. 2010 Apr;115(4):745-752. doi: 10.1097/AOG.0b013e3181d4450d.

    PubMed 20308834

  • Graseck AS, Secura GM, Allsworth JE, Madden T, Peipert JF. Home compared with clinic-based screening for sexually transmitted infections: a randomized controlled trial. Obstet Gynecol. 2010 Dec;116(6):1311-1318. doi: 10.1097/AOG.0b013e3181fae60d.

    PubMed 21099596

  • Shih SL, Kebodeaux CA, Secura GM, Allsworth JE, Madden T, Peipert JF. Baseline correlates of inconsistent and incorrect condom use among sexually active women in the contraceptive CHOICE Project. Sex Transm Dis. 2011 Nov;38(11):1012-9. doi: 10.1097/OLQ.0b013e318225f8c3.

    PubMed 21992976

  • Madden T, Secura GM, Allsworth JE, Peipert JF. Comparison of contraceptive method chosen by women with and without a recent history of induced abortion. Contraception. 2011 Dec;84(6):571-7. doi: 10.1016/j.contraception.2011.03.018. Epub 2011 May 4.

    PubMed 22078185

  • Madden T, Proehl S, Allsworth JE, Secura GM, Peipert JF. Naproxen or estradiol for bleeding and spotting with the levonorgestrel intrauterine system: a randomized controlled trial. Am J Obstet Gynecol. 2012 Feb;206(2):129.e1-8. doi: 10.1016/j.ajog.2011.09.021. Epub 2011 Sep 24.

    PubMed 22055339

  • Madden T, Grentzer JM, Secura GM, Allsworth JE, Peipert JF. Risk of bacterial vaginosis in users of the intrauterine device: a longitudinal study. Sex Transm Dis. 2012 Mar;39(3):217-22. doi: 10.1097/OLQ.0b013e31823e68fe.

    PubMed 22337109

  • Skala SL, Secura GM, Peipert JF. Factors associated with screening for sexually transmitted infections. Am J Obstet Gynecol. 2012 Apr;206(4):324.e1-6. doi: 10.1016/j.ajog.2012.02.020. Epub 2012 Feb 28.

    PubMed 22464074

Questions about this trial

What is this clinical trial studying?

An observational study of Unintended Pregnancy and Teen Births, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distribution of contraceptive method chosen (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01986439, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015.

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