Quick Start of Highly Effective Contraception

NCT02076217 | Active Not Recruiting DMC

• 1 other identifier: 67314
• Study Type: observational
• Target: 1,030
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

unprotected intercourse 6-14 days prior to contraception

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

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

Interventions

Copper T-380 IUD DRUG

Also known as: Paragard IUD

unprotected intercourse 6-14 days prior to contraception

LNG IUD DRUG

Also known as: Mirena IUD, Skyla IUD

unprotected intercourse 6-14 days prior to contraception

Contraceptive implant Nexplanon DEVICE

Also known as: Etonorgestrel contraceptive implant, Implanon, Nexplanon

unprotected intercourse 6-14 days prior to contraception

Depo-Provera DRUG

Also known as: Depo, Intramuscular medroxyprogesterone acetate

unprotected intercourse 6-14 days prior to contraception

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women presenting to IRB approved clinics requesting highly effective contraception (an IUD, Nexplanon®, or Depo-Provera) .

You may qualify if:

• Women between the ages of 15 and 45 years who request injectable, subdermal, or intrauterine contraception, 6-14 days after having unprotected intercourse.

You may not qualify if:

• History of tubal ligation or hysterectomy.
• Positive urine pregnancy test

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Planned Parenthood Association of Utah

West Valley City, Utah, 84119, United States

Location

Related Publications (4)

• 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.

  PMID: 16488819 BACKGROUND

• 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.

  PMID: 19305327 BACKGROUND

• 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.

  PMID: 12384200 BACKGROUND

• 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.

  PMID: 33706343 DERIVED

MeSH Terms

Interventions

Medroxyprogesterone Acetate; DEPO

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• David Turok, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 3, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

US (1)