Trial of Immediate Versus Delayed Initiation of Oral Contraceptive Pills After Abortion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00235534
First received: October 6, 2005
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

This is a randomized, controlled trial investigating whether immediate versus standard, "Sunday Start", initiation of oral contraceptive pills (OCPs) in post-abortion subjects can improve compliance and the continuation of contraception. Immediate initiation of OCPs 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 OCPs into a second pill pack. The primary hypothesis of this study is that immediate initiation of OCPs in post-abortal women will improve the continuation of contraception over delayed initiation on the first Sunday after an abortion.


Condition Intervention
Abortion
Behavioral: Immediate initiation of OCPs
Behavioral: Delayed initiation of OCPs

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 Oral Contraceptive Pills 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:
  • Continuation of OCPs after abortion [ Time Frame: Two and six months post-enrollment ] [ Designated as safety issue: No ]
    Assessed by phone survey


Secondary Outcome Measures:
  • Compliance with OCPs after abortion [ Time Frame: Two and six months post-enrollment ] [ Designated as safety issue: No ]
    assessed by phone survey

  • Bleeding patterns on OCPs after abortion [ Time Frame: Two months post-abortion ] [ Designated as safety issue: No ]
    assessed by phone survey

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


Enrollment: 300
Study Start Date: October 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate start
Initiate selected birth control method before leaving the clinic at the time of the abortion procedure.
Behavioral: Immediate initiation of OCPs
Active Comparator: Sunday start
Begin birth control the first Sunday after leaving the clinic
Behavioral: Delayed initiation of OCPs

Detailed Description:

The United States has a higher rate of unintended pregnancy than Canada or any other developed nation in Europe. OCPs are the most common method of hormonal 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 OCP use. Several recent studies have examined the "Quick Start", or initiation of OCPs in front of the provider while still at the clinic, regardless of time in the cycle. These studies have shown that women who swallowed the first OCP in the clinic were more likely to continue the OCP 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 OCP 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 OCPs are 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 take the first of their OCPs while still in the clinic after their abortion may improve compliance and continuation of OCP 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 single pack of combination OCPs and a one-year prescription after their TAB. The women in the immediate start arm will then take their first OCP in the clinic, observed by clinic staff, before leaving. The controls will be instructed to begin the OCPs 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 OCPs. 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 OCPs for post-abortion contraception.

Exclusion Criteria:

  • Gestational age above 23 weeks and 1 day.
  • Any absolute contraindication for combination OCP 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: NCT00235534

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

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00235534     History of Changes
Other Study ID Numbers: H11779-26464-01
Study First Received: October 6, 2005
Last Updated: November 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
abortion
randomized
contraception
pregnancy
compliance
continuation
oral contraceptive pills

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 30, 2014