Quick Start of Highly Effective Contraception

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02076217
• Other study ID #: 67314
• Status: Active, not recruiting
• Start date: February 2014
• Est. completion date: January 2026

Study information

• Verified date: June 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1030
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Birth Control
• Contraception
• Contraceptive Implant
• Emergencies
• Emergency Contraception
• IUD

Intervention

Drug:
• Copper T-380 IUD

• LNG IUD

Device:
• Contraceptive implant Nexplanon

Drug:
• Depo-Provera

Locations

Country	Name	City	State
United States	Planned Parenthood Association of Utah	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (3)

Sadler LS, Chen JY, Daley AM, Leventhal JM, Reynolds H. Reproductive care and rates of pregnancy in teenagers with negative pregnancy test results. J Adolesc Health. 2006 Mar;38(3):222-9. doi: 10.1016/j.jadohealth.2004.10.007. — View Citation

Schwarz EB, Kavanaugh M, Douglas E, Dubowitz T, Creinin MD. Interest in intrauterine contraception among seekers of emergency contraception and pregnancy testing. Obstet Gynecol. 2009 Apr;113(4):833-839. doi: 10.1097/AOG.0b013e31819c856c. — View Citation

Westhoff C, Kerns J, Morroni C, Cushman LF, Tiezzi L, Murphy PA. Quick start: novel oral contraceptive initiation method. Contraception. 2002 Sep;66(3):141-5. doi: 10.1016/s0010-7824(02)00351-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rates in the first month of contraceptive use	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.	4 weeks from contraception initiation