RCT: Can a Single Counseling Phone Call Improve Contraception After an Abortion? (PPR)
14. august 2019 opdateret af: University of California, San Francisco
A Randomized Controlled Trial: Contraceptive Counseling After an Abortion
Hypothesis: Use of an effective contraceptive six weeks after abortion will be higher in the treatment group than in the control group.
Primary Aim ·To determine use of an effective contraceptive method six weeks after abortion in women who choose combined hormonal contraception (CHC) and who receive a three-week educational phone call as compared to women who do not receive the intervention.
Secondary Aims
- To describe the most common concerns and logistical problems women experience with initiating and adhering to CHC after abortion.
- To describe the concerns that lead to discontinuation or method change. *To assess feasibility of conducting a follow-up telephone call in this population This is a randomized, controlled trial to assess the effect of a three-week follow-up phone call in women who choose combined hormonal contraception on the day of their abortion at the San Francisco General Hospital Women's Options Center. Subjects randomized to the treatment group will receive an interventional phone call three weeks after their abortion; participants randomized to the control group will not receive the call. All subjects will receive a follow-up call six weeks after their abortion to assess and compare method use between the two groups. Calls will be made at three- and six-weeks post abortion in order to give subjects enough time to initiate CHC and to assess continuation into the second month of the method. Data will be collected at baseline, during the intervention for the treatment group and during the final follow-up call for both groups. The primary outcome is use of an effective contraceptive six weeks after abortion.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
207
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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California
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San Francisco, California, Forenede Stater, 94110
- San Francisco General Hospital
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
15 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Women over the age of 15 who choose pill, patch or ring to begin after their abortion
- Women able and willing to be contacted by phone for up to 2 months after enrollment
Exclusion Criteria:
- Women who do not speak and read English or Spanish
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Control
The control group will not receive a counseling phone call one month after enrollment.
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Eksperimentel: Intervention
Intervention arm receives a counseling phone call 3 to 4 weeks after enrollment.
The call is from a health educator intended to assist with contraception.
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Subjects in the treatment arm will receive a phone call from a health educator to assist with contraception, 3 to 4 weeks after enrollment.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Using an Effective Contraceptive Method 6 Weeks After Abortion
Tidsramme: 6 weeks after abortion procedure
|
To determine use of an effective contraceptive method six weeks after abortion in women who choose combined hormonal contraception (CHC) and who receive a three-week educational phone call as compared to women who do not receive the intervention.
|
6 weeks after abortion procedure
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Reasons for Discontinuation of Contraception
Tidsramme: 6 weeks after abortion procedure
|
To describe the most common concerns and logistical problems women experience with initiating and adhering to CHC after abortion. To describe the concerns that lead to discontinuation or method change. To assess feasibility of conducting a follow-up telephone call in this population |
6 weeks after abortion procedure
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jody Steinauer, MD, MAS, University of California, San Francisco
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
21. marts 2011
Primær færdiggørelse (Faktiske)
1. januar 2013
Studieafslutning (Faktiske)
1. januar 2013
Datoer for studieregistrering
Først indsendt
9. september 2010
Først indsendt, der opfyldte QC-kriterier
10. september 2010
Først opslået (Skøn)
13. september 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. august 2019
Sidst verificeret
1. august 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- RCT 10-01978
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .