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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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California
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San Francisco, California, Forenede Stater, 94110
- Women's Options Clinic at San Francisco General Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Continuation of OCPs after abortion
Tidsramme: Two and six months post-enrollment
|
Assessed by phone survey
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Two and six months post-enrollment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Compliance with OCPs after abortion
Tidsramme: Two and six months post-enrollment
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assessed by phone survey
|
Two and six months post-enrollment
|
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Bleeding patterns on OCPs after abortion
Tidsramme: Two months post-abortion
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assessed by phone survey
|
Two months post-abortion
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Satisfaction with OCPs after abortion
Tidsramme: six months post-enrollment
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assessed by phone survey
|
six months post-enrollment
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Jody E Steinauer, MD, MAS, University of California, San Francisco
- Studieleder: Sarah W Prager, MD, University of California, San Francisco
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- H11779-26464-01
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