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Quick Start of Highly Effective Contraception

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02076217
Recruitment Status : Recruiting
First Posted : March 3, 2014
Last Update Posted : April 28, 2021
Information provided by (Responsible Party):
David Turok, University of Utah

Brief Summary:
This project will quantify rates of contraceptive failure when unprotected intercourse occurs 6-14 days prior to initiation of highly effective reversible contraceptives (such as IUD's and Implants).

Condition or disease Intervention/treatment
IUD Contraceptive Implant Contraception Birth Control Emergency Contraception Drug: Copper T-380 IUD Drug: LNG IUD Device: Contraceptive implant Nexplanon Drug: Depo-Provera

Detailed Description:
Women seeking emergency contraception (EC) frequently report multiple recent episodes of unprotected sex. Although high sensitivity urine pregnancy tests effectively rule-out pregnancy resulting from sex that occurred more than 14 days ago, clinicians are frequently concerned that pregnancy may result from unprotected sex that occurred <14 days prior to IUD placement. Placement of a copper IUD within 5 days of unprotected sex is a highly effective form of EC. Among 52 Chinese women who reported unprotected intercourse 5-7 days prior to copper IUD insertion, no pregnancies occurred. However, the effectiveness of the copper IUD when unprotected sex occurs 7-14 days prior to IUD placement is unknown. Intrauterine pregnancies rarely occur with a copper IUD in place. As some clinicians are concerned about injuring a pregnancy that occurs with an IUD in place, women who have had unprotected sex 7-14 days prior to requesting IUD placement are typically told they must use another, less effective, contraceptive for 2+ weeks and then return to obtain an IUD. To remove this barrier to emergency placement of a copper IUD, we propose to study rates of pregnancy when a copper IUD is placed "any time a urine pregnancy test is negative." We believe that simplifying guidance regarding the recommended timing of copper IUD placement has the potential to significantly increase the number of women offered "same-day" IUD service.

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Study Type : Observational
Estimated Enrollment : 1030 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rates of Contraceptive Failure When Unprotected Intercourse Has Occurred 6-14 Days Prior to Contraceptive Initiation
Actual Study Start Date : February 2014
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Group/Cohort Intervention/treatment
unprotected intercourse 6-14 days prior to contraception
Women who initiate highly effective reversible contraception within 6-14 days of unprotected intercourse.
Drug: Copper T-380 IUD
Other Name: Paragard IUD

Other Name: Mirena IUD, Skyla IUD

Device: Contraceptive implant Nexplanon
Other Name: Etonorgestrel contraceptive implant, Implanon, Nexplanon

Drug: Depo-Provera
Other Name: Depo, Intramuscular medroxyprogesterone acetate

Primary Outcome Measures :
  1. Pregnancy rates in the first month of contraceptive use [ Time Frame: 4 weeks from contraception initiation ]
    This study is designed to provide clinicians and their patients with information regarding rates of contraceptive failure (i.e. undesired pregnancy) when contraception is initiated or placed for a woman who has a negative pregnancy test, but reports having had unprotected intercourse 6-14 days prior to requesting contraception.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women presenting to IRB approved clinics requesting highly effective contraception (an IUD, Nexplanon®, or Depo-Provera) .

Inclusion Criteria:

  • Women between the ages of 15 and 45 years who request injectable, subdermal, or intrauterine contraception, 6-14 days after having unprotected intercourse.

Exclusion Criteria:

  • History of tubal ligation or hysterectomy.
  • Positive urine pregnancy test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02076217

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Contact: David Turok, MD 801-581-6170

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United States, Utah
Planned Parenthood Association of Utah Recruiting
West Valley City, Utah, United States, 84119
Contact: Corinne Sexsmith    801-581-6170   
Principal Investigator: David Turok, MD         
Sponsors and Collaborators
University of Utah
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Principal Investigator: David Turok, MD University of Utah
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David Turok, MD, University of Utah Identifier: NCT02076217    
Other Study ID Numbers: 67314
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Keywords provided by David Turok, University of Utah:
Highly Effective Contraception
Emergency Contraception
Birth Control
LARC (Long Acting Reversible Contraception)
HERC (Highly Effective Contraception)
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes
Medroxyprogesterone Acetate
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Trace Elements
Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents, Hormonal
Contraceptives, Oral, Synthetic
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists