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Quick Start of Highly Effective Contraception

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ClinicalTrials.gov Identifier: NCT02076217
Recruitment Status : Recruiting
First Posted : March 3, 2014
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
David Turok, University of Utah

Tracking Information
First Submitted Date February 27, 2014
First Posted Date March 3, 2014
Last Update Posted Date November 13, 2020
Actual Study Start Date February 2014
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 28, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: February 28, 2014)
Contraceptive Continuation Rates [ Time Frame: 6 months after contraception initiation ]
Proportion of patients who initiate a certain contraceptive method who continue to use it at 6 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quick Start of Highly Effective Contraception
Official Title Rates of Contraceptive Failure When Unprotected Intercourse Has Occurred 6-14 Days Prior to Contraceptive Initiation
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).
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women presenting to IRB approved clinics requesting highly effective contraception (an IUD, Nexplanon®, or Depo-Provera) .
Condition
  • IUD
  • Contraceptive Implant
  • Contraception
  • Birth Control
  • Emergency Contraception
Intervention
  • Drug: Copper T-380 IUD
    Other Name: Paragard IUD
  • Drug: LNG 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
Study Groups/Cohorts unprotected intercourse 6-14 days prior to contraception
Women who initiate highly effective reversible contraception within 6-14 days of unprotected intercourse.
Interventions:
  • Drug: Copper T-380 IUD
  • Drug: LNG IUD
  • Device: Contraceptive implant Nexplanon
  • Drug: Depo-Provera
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 28, 2014)
1030
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2026
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 15 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: David Turok, MD 801-581-6170 david.turok@hsc.utah.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02076217
Other Study ID Numbers 67314
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party David Turok, University of Utah
Study Sponsor University of Utah
Collaborators Not Provided
Investigators
Principal Investigator: David Turok, MD University of Utah
PRS Account University of Utah
Verification Date November 2020