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OpenTrials
Completed

NCT Number: NCT02076217

Quick Start of Highly Effective Contraception

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).

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Key information

Age range

15 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Planned Parenthood Association of Utah

West Valley City, Utah, 84119, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Copper T-380 IUD

Drug

Other names: Paragard IUD

LNG IUD

Drug

Other names: Mirena IUD, Skyla IUD

Contraceptive implant Nexplanon

Device

Other names: Etonorgestrel contraceptive implant, Implanon, Nexplanon

Depo-Provera

Drug

Other names: Depo, Intramuscular medroxyprogesterone acetate

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Rates of Contraceptive Failure When Unprotected Intercourse Has Occurred 6-14 Days Prior to Contraceptive Initiation

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2014
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.