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

NCT ID: NCT00235534

Last Updated: 2012-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Abortion

Keywords

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abortion randomized contraception pregnancy compliance continuation oral contraceptive pills

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Immediate start

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

Group Type EXPERIMENTAL

Immediate initiation of OCPs

Intervention Type BEHAVIORAL

Sunday start

Begin birth control the first Sunday after leaving the clinic

Group Type ACTIVE_COMPARATOR

Delayed initiation of OCPs

Intervention Type BEHAVIORAL

Interventions

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Immediate initiation of OCPs

Intervention Type BEHAVIORAL

Delayed initiation of OCPs

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jody E Steinauer, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Sarah W Prager, MD

Role: STUDY_DIRECTOR

University of California, San Francisco

Locations

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Women's Options Clinic at San Francisco General Hospital

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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H11779-26464-01

Identifier Type: -

Identifier Source: org_study_id