Clinical Trials Directory

Trials / Completed

CompletedNCT02076217

Quick Start of Highly Effective Contraception

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

Status
Completed
Phase
Study type
Observational
Enrollment
270 (actual)
Sponsor
University of Utah · Academic / Other
Sex
Female
Age
15 Years – 45 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGCopper T-380 IUD
DRUGLNG IUD
DEVICEContraceptive implant Nexplanon
DRUGDepo-Provera

Timeline

Start date
2014-02-01
Primary completion
2021-10-01
Completion
2021-10-01
First posted
2014-03-03
Last updated
2026-04-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02076217. Inclusion in this directory is not an endorsement.