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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 : July 11, 2019
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
David Turok, University of Utah

Brief Summary:
This project will quantify rates of contraceptive failure when unprotected intercourse occurs 5-14 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
Study Start Date : February 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Group/Cohort Intervention/treatment
unprotected intercourse 5-14 days prior to contraception
Women who initiate highly effective reversible contraception within 5-14 days of unprotected intercourse.
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




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.


Secondary Outcome Measures :
  1. 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



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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) .
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

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 ClinicalTrials.gov identifier (NCT number): NCT02076217


Locations
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United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Melissa Papic    412-692-4317    papicmj@upmc.edu   
Principal Investigator: Eleanor Schwarz, MD         
United States, Utah
Planned Parenthood Association of Utah Not yet recruiting
West Valley City, Utah, United States, 84119
Contact: Jessie Barlow    801-973-9675    jessie.barlow@ppau.org   
Principal Investigator: David Turok, MD         
Sponsors and Collaborators
University of Utah
University of Pittsburgh
Investigators
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Principal Investigator: David Turok, MD University of Utah
Principal Investigator: Eleanor Schwarz, MD University of Pittsburgh

Publications:
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Responsible Party: David Turok, MD, University of Utah
ClinicalTrials.gov Identifier: NCT02076217     History of Changes
Other Study ID Numbers: 67314
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
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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Emergencies
Disease Attributes
Pathologic Processes
Medroxyprogesterone Acetate
Contraceptive Agents
Medroxyprogesterone
Etonogestrel
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents