MedDataX Logo

Quick Start of Highly Effective Contraception

NCT ID: NCT02076217

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1030 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

IUD Contraceptive Implant Contraception Birth Control Emergency Contraception

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Highly Effective Contraception Emergency Contraception Birth Control LARC (Long Acting Reversible Contraception) HERC (Highly Effective Contraception)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

unprotected intercourse 6-14 days prior to contraception

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

Copper T-380 IUD

Intervention Type DRUG

LNG IUD

Intervention Type DRUG

Contraceptive implant Nexplanon

Intervention Type DEVICE

Depo-Provera

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Copper T-380 IUD

Intervention Type DRUG

LNG IUD

Intervention Type DRUG

Contraceptive implant Nexplanon

Intervention Type DEVICE

Depo-Provera

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Paragard IUD Mirena IUD, Skyla IUD Etonorgestrel contraceptive implant, Implanon, Nexplanon Depo, Intramuscular medroxyprogesterone acetate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Utah

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Turok

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Turok, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Planned Parenthood Association of Utah

West Valley City, Utah, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 16488819 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19305327 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12384200 (View on PubMed)

Boraas CM, Sanders JN, Schwarz EB, Thompson I, Turok DK. Risk of Pregnancy With Levonorgestrel-Releasing Intrauterine System Placement 6-14 Days After Unprotected Sexual Intercourse. Obstet Gynecol. 2021 Apr 1;137(4):623-625. doi: 10.1097/AOG.0000000000004118.

Reference Type DERIVED
PMID: 33706343 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

67314

Identifier Type: -

Identifier Source: org_study_id