Trial record 5 of 382 for:    contraception

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00235547
First received: October 6, 2005
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Abortion
Behavioral: timing of initiation of transdermal patch after an abortion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immediate Versus Delayed Initiation of Transdermal Hormonal Contraception After Therapeutic Abortion: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • compare use of patch after abortion between study arms [ Time Frame: six months after enrollment/abortion ] [ Designated as safety issue: No ]
    we will also describe what participants were using two months post-abortion


Secondary Outcome Measures:
  • describe post abortion contraception use, side effects and patient satisfaction [ Time Frame: six months post enrollment ] [ Designated as safety issue: No ]
    Secondary outcome will describe contraception use, side effects and patients satisfaction between each study arm as well as the study sample as a whole at two and six months post-enrollment (enrollment is same day as abortion)

  • Bleeding patterns on OCPs after abortion [ Time Frame: assessed at two months post enrollment ] [ Designated as safety issue: No ]
    patients are asked at the two month follow-up what about bleeding patterns in the first couple of weeks after their abortion

  • Satisfaction with OCPs after abortion [ Time Frame: six months post-enrollment ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: August 2005
Study Completion Date: December 2012
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: contraception-Immediate start
contraception after abortion and before leaving the clinic, observed by clinic staff
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
Active Comparator: Contraception-Delayed start
instructed to begin contraception the first Sunday after leaving the clinic
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

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.

  Eligibility

Ages Eligible for Study:   13 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235547

Locations
United States, California
Women's Options Clinic at San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Jody E Steinauer, MD, MAS University of California, San Francisco
Study Director: Sarah W Prager, MD University of California, San Francisco
  More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00235547     History of Changes
Other Study ID Numbers: H11779-2703-01
Study First Received: October 6, 2005
Last Updated: July 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
abortion
randomized
contraception
pregnancy
compliance
continuation
contraceptive patch
transdermal hormonal contraception

ClinicalTrials.gov processed this record on July 22, 2014