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

NCT00235534 | Completed

• 1 other identifier: H11779-26464-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abortion

Keywords

abortion; randomized; contraception; pregnancy; compliance; continuation; oral contraceptive pills

Outcome Measures

Primary Outcomes (1)

• Continuation of OCPs after abortion

  Assessed by phone survey

  Two and six months post-enrollment

Secondary Outcomes (3)

• Compliance with OCPs after abortion

  Two and six months post-enrollment

• Bleeding patterns on OCPs after abortion

  Two months post-abortion

• Satisfaction with OCPs after abortion

  six months post-enrollment

Study Arms (2)

Immediate start

EXPERIMENTAL

Initiate selected birth control method before leaving the clinic at the time of the abortion procedure.

Behavioral: Immediate initiation of OCPs

Sunday start

ACTIVE COMPARATOR

Begin birth control the first Sunday after leaving the clinic

Behavioral: Delayed initiation of OCPs

Interventions

Immediate initiation of OCPs BEHAVIORAL

Immediate start

Delayed initiation of OCPs BEHAVIORAL

Sunday start

Eligibility Criteria

• Age: 13 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Women's Options Clinic at San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jody E Steinauer, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Sarah W Prager, MD

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2005
• First Posted: October 10, 2005
• Study Start: October 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 19, 2012

Record last verified: 2012-11

Locations

US (1)