Trial of Immediate Versus Delayed Initiation of Oral Contraceptive Pills After Abortion
Immediate Versus Delayed Initiation of Oral Contraceptive Pills After Therapeutic Abortion - A Randomized Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
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California
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San Francisco, California, Förenta staterna, 94110
- Women's Options Clinic at San Francisco General Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Immediate start
Initiate selected birth control method before leaving the clinic at the time of the abortion procedure.
|
|
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Aktiv komparator: Sunday start
Begin birth control the first Sunday after leaving the clinic
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Continuation of OCPs after abortion
Tidsram: Two and six months post-enrollment
|
Assessed by phone survey
|
Two and six months post-enrollment
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Compliance with OCPs after abortion
Tidsram: Two and six months post-enrollment
|
assessed by phone survey
|
Two and six months post-enrollment
|
|
Bleeding patterns on OCPs after abortion
Tidsram: Two months post-abortion
|
assessed by phone survey
|
Two months post-abortion
|
|
Satisfaction with OCPs after abortion
Tidsram: six months post-enrollment
|
assessed by phone survey
|
six months post-enrollment
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Jody E Steinauer, MD, MAS, University of California, San Francisco
- Studierektor: Sarah W Prager, MD, University of California, San Francisco
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- H11779-26464-01
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