Quick Start of Highly Effective Contraception

Utah System of Higher Education (USHE)

Status: Active, not recruiting

Conditions: Contraception; Emergency Contraception; Contraceptive Implant; Birth Control; IUD

Treatments: Drug: LNG IUD; Drug: Depo-Provera; Drug: Copper T-380 IUD; Device: Contraceptive implant Nexplanon

Study type: Observational

Funder types: Other

Identifiers

NCT02076217

67314

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,030 estimated patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,030 participants in 1 patient group

unprotected intercourse 6-14 days prior to contraception

Description:

Women who initiate highly effective reversible contraception within 6-14 days of unprotected intercourse.

Treatment:

Device: Contraceptive implant Nexplanon

Drug: Copper T-380 IUD

Drug: Depo-Provera

Drug: LNG IUD