Clinical trial NCT00235534: Trial of Immediate Versus Delayed Initiation of Oral Contraceptive Pills After Abortion
Official title: Immediate Versus Delayed Initiation of Oral Contraceptive Pills After Therapeutic Abortion - A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion
Keywords: abortion
randomized
contraception
pregnancy
compliance
continuation
oral contraceptive pills
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2005-10-10
Enrollment: 300
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: Continuation of OCPs after abortion
timeFrame: Two and six months post-enrollment
Secondary outcomes:
measure: Compliance with OCPs after abortion
timeFrame: Two and six months post-enrollment
measure: Bleeding patterns on OCPs after abortion
timeFrame: Two months post-abortion
measure: Satisfaction with OCPs after abortion
timeFrame: six months post-enrollment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Women's Options Clinic at San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jody E Steinauer, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Sarah W Prager, MD
role: STUDY_DIRECTOR
References: