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Trial of Immediate Versus Delayed Initiation of Transdermal Hormonal Contraception After Therapeutic Abortion

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ClinicalTrials.gov Identifier: NCT00235547
Recruitment Status : Completed
First Posted : October 10, 2005
Results First Posted : June 10, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE October 6, 2005
First Posted Date  ICMJE October 10, 2005
Results First Submitted Date  ICMJE March 6, 2019
Results First Posted Date  ICMJE June 10, 2019
Last Update Posted Date August 29, 2019
Study Start Date  ICMJE August 2005
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
Number of Participants Who Use Patch After Abortion, by Study Arm [ Time Frame: six months after enrollment/abortion ]
we will also describe what participants were using two months post-abortion
Original Primary Outcome Measures  ICMJE
 (submitted: October 6, 2005)
Continuation of OCPs after abortion.
Change History Complete list of historical versions of study NCT00235547 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
Number of Participants Who Were Using Effective Method at 6 Months Post-enrollment [ Time Frame: six months post enrollment ]
An effective method is defined as a hormonal method or intra-uterine device
Original Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2005)
  • Compliance with OCPs after abortion.
  • Bleeding patterns on OCPs after abortion.
  • Satisfaction with OCPs after abortion.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Immediate Versus Delayed Initiation of Transdermal Hormonal Contraception After Therapeutic Abortion
Official Title  ICMJE Immediate Versus Delayed Initiation of Transdermal Hormonal Contraception After Therapeutic Abortion: A Randomized Trial
Brief Summary This is a randomized, controlled trial investigating whether immediate versus standard, "Sunday Start", initiation of transdermal hormonal contraception (the patch) in post-abortion subjects can improve compliance and the continuation of contraception. Immediate initiation of the patch has been studied in women seeking contraception when they are not immediately post-abortion, and this "Quick Start" method has been shown to improve the continuation of the patch into a second month. The primary hypothesis of this study is that immediate initiation of the patch in post-abortal women will improve the continuation of contraception over delayed initiation on the first Sunday after an abortion.
Detailed Description

The United States has a higher rate of unintended pregnancy than Canada or any other developed nation in Europe. Hormonal contraception is the most common method of contraception used in this country. Perfect use can lead to failure rates as low as 0.1% per year. Actual failure rates are much higher, often due to non-compliance with contraception use. Several recent studies have examined the "Quick Start", or initiation of hormonal contraception (OCPs and patch) in front of the provider while still at the clinic, regardless of time in the cycle. These studies have shown that women who placed the first patch in the clinic were more likely to continue the patch into the second month. Women who are seen in clinics for a therapeutic abortion (TAB) are often at extremely high risk for another unintended/unwanted pregnancy. If compliance in patch use could be improved in this group of women, unintended/unwanted pregnancy rates could be reduced. One concern about the "Quick Start" technique is that women may have already ovulated or conceived when the patch is initiated mid-cycle. In the post-abortal setting, this is not a concern. Applying the "Quick Start" technique to post-abortion patients and having women place the first patch while still in the clinic after their abortion may improve compliance and continuation of patch use.

This is a prospective, randomized, controlled trial in post-abortal women, and will last approximately 24 months. All of the study subjects will receive a month's worth of the patch and a one-year prescription after their TAB. The women in the immediate start arm will then place their first patch in the clinic, observed by clinic staff, before leaving. The controls will be instructed to place the first patch on the first Sunday following their abortion. All subjects will receive the same medication with the only difference being the timing of initiation of the patch. Measurements of continuation will be determined by telephone interviews administered at two and six months after the subjects' abortion.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Abortion
Intervention  ICMJE Behavioral: timing of initiation of transdermal patch after an abortion
the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic
Study Arms  ICMJE
  • Active Comparator: contraception-Immediate start
    contraception after abortion and before leaving the clinic, observed by clinic staff
    Intervention: Behavioral: timing of initiation of transdermal patch after an abortion
  • Active Comparator: Contraception-Delayed start
    instructed to begin contraception the first Sunday after leaving the clinic
    Intervention: Behavioral: timing of initiation of transdermal patch after an abortion
Publications * Steinauer JE, Sokoloff A, Roberts EM, Drey EA, Dehlendorf CE, Prager SW. Immediate versus delayed initiation of the contraceptive patch after abortion: a randomized trial. Contraception. 2014 Jan;89(1):42-7. doi: 10.1016/j.contraception.2013.03.002. Epub 2013 Mar 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2019)
298
Original Enrollment  ICMJE
 (submitted: October 6, 2005)
300
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Any woman aged 13-45 who presents to the Women's Options Clinic and desires to use the patch for post-abortion contraception.

Exclusion Criteria:

  • Gestational age above 23 weeks and 1 day.
  • Any absolute contraindication for patch use (smoking > 20 cigarettes a day over age 35, history of venous thromboembolic event or pulmonary embolism, history of or current ischemic heart disease, history of stroke, vascular disease, complicated valvular heart disease [pulmonary hypertension, atrial fibrillation, history of subacute bacterial endocarditis], severe hypertension with blood pressure >160/100, migraines with focal neurologic symptoms, current breast cancer, active viral hepatitis, severe cirrhosis, or benign or malignant liver tumors).
  • Patients who speak languages other than English or Spanish.
  • Patients who do not have a phone or who have a phone where any contact might compromise the confidentiality of their abortions.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 13 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00235547
Other Study ID Numbers  ICMJE H11779-2703-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jody E Steinauer, MD, MAS University of California, San Francisco
Study Director: Sarah W Prager, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP