Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120224
Status:
COMPLETED
Last Update Posted:
2007-04-27
First Post:
2005-06-30
Brief Title:
De-Medicalizing Mifepristone Medical Abortion
Sponsor:
Gynuity Health Projects
Organization:
Gynuity Health Projects
Study Overview
Official Title:
De-Medicalizing Mifepristone Medical Abortion
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate the possibility that medical abortion using mifepristone and misoprostol - a safe proven therapy for terminating early first trimester pregnancy - can be administered in a manner that is simpler and less costly than that routinely employed in the United States
The researchers hypothesize that
1 Practitioners themselves based on history and examination but without sonography are able to dependably and correctly determine which patients are eligible for medical abortion and which patients either are not eligible or require further evaluation to determine eligibility
2 Practitioners themselves based on a symptom diary and low-sensitivity pregnancy test but without sonography are able to dependably and correctly determine when a successful medical abortion has taken place and when referral for other possible outcomes should be made
3 A symptom diary and low-sensitivity pregnancy test are safe and effective means of separating those women who could benefit from a follow-up visit from those who do not need one
The researchers hypothesize that
1 Practitioners themselves based on history and examination but without sonography are able to dependably and correctly determine which patients are eligible for medical abortion and which patients either are not eligible or require further evaluation to determine eligibility
2 Practitioners themselves based on a symptom diary and low-sensitivity pregnancy test but without sonography are able to dependably and correctly determine when a successful medical abortion has taken place and when referral for other possible outcomes should be made
3 A symptom diary and low-sensitivity pregnancy test are safe and effective means of separating those women who could benefit from a follow-up visit from those who do not need one
Detailed Description:
Mifepristone medical abortion has been available in France for a decade and a half and in the United States since 2001 Over this time it has been demonstrated to be as safe as or safer than either surgical abortion or carrying a pregnancy to term Furthermore as medical abortion employs medications rather than surgery to terminate a pregnancy it has the potential to greatly increase the availability of locations providing abortion services in the US eliminating as it does the need for expensive equipment and surgical training
Unfortunately however although the availability of medical abortion in the US has increased with time it has yet to achieve its full potential In large part this appears to be due to two factors which inhibit providers from offering and women from choosing the procedure 1 Although the approved US medical abortion regimen does not require providers to use ultrasound examination as part of the procedure it has become common practice for providers to do so This both increases the cost of the procedure and limits the number of facilities that can offer it 2 While surgical abortion typically requires only one clinic visit medical abortion requires officially three or in practice two visits making it more expensive less convenient and less attractive to women
There is already a great deal of evidence that medical abortion can be safely offered with two or even fewer office visits and without routine ultrasonography Most medical abortions in the United States in fact currently require only two visits and the possibility exists that women could self-screen at home based on a symptom checklist to determine if the second of these the follow-up visit is necessary - an approach that could spare the large majority of medical abortion clients who have uncomplicated courses an extra trip to the clinic There are in addition several less-expensive and less technology-intensive approaches to gathering the diagnostic information currently being provided pre- and post-procedure by ultrasonography
The purpose of the current study is to test the feasibility and efficacy of an approach to medical abortion that forgoes the routine use of ultrasonography It will also provide evidence on the feasibility of eliminating the requirement for a universal follow-up visit based on self-screening by medical abortion clients In providing data to make these tests however the study protocol will not in any way abridge the medical abortion care currently received by clients at the participating facilities The study will permit clients to receive standard care including a follow-up visit and pre- and post-procedure ultrasound examinations in all cases while gathering valuable information which we hope will provide a basis for simplifying standard care in the future
The research questions to be answered by the study are
1 Do an interview with the abortion client a pregnancy test and a physical exam provide adequate information to determine which abortion clients are eligible for the medical abortion procedure and which should be referred for sonography or other diagnostic tests before making such a determination
2 Can a self-administered symptom diary and a follow-up low-sensitivity pregnancy test provide an adequate basis to determine whether a woman has undergone a successful medical abortion or whether she requires a sonographic exam or other diagnostic test in order to make this determination
3 Does a post-abortion pelvic examination provide valuable additional information for determining whether a woman has undergone a successful medical abortion or whether she requires a sonographic exam or other diagnostic test in order to make this determination
4 Can a self-administered symptom diary and a low-sensitivity pregnancy test provide an adequate basis for determining which medical abortion clients require a follow-up visit
The research hypotheses are
1 Practitioners themselves based on history and examination but without sonography are able to dependably and correctly determine which patients are eligible for medical abortion and which patients either are not eligible or require further evaluation to determine eligibility
2 Practitioners themselves based on a symptom diary and low-sensitivity pregnancy test but without sonography are able to dependably and correctly determine when a successful medical abortion has taken place and when referral for other possible outcomes should be made
3 A symptom diary and low-sensitivity pregnancy test are safe and effective means of separating those women who could benefit from a follow-up visit from those who do not need one
Unfortunately however although the availability of medical abortion in the US has increased with time it has yet to achieve its full potential In large part this appears to be due to two factors which inhibit providers from offering and women from choosing the procedure 1 Although the approved US medical abortion regimen does not require providers to use ultrasound examination as part of the procedure it has become common practice for providers to do so This both increases the cost of the procedure and limits the number of facilities that can offer it 2 While surgical abortion typically requires only one clinic visit medical abortion requires officially three or in practice two visits making it more expensive less convenient and less attractive to women
There is already a great deal of evidence that medical abortion can be safely offered with two or even fewer office visits and without routine ultrasonography Most medical abortions in the United States in fact currently require only two visits and the possibility exists that women could self-screen at home based on a symptom checklist to determine if the second of these the follow-up visit is necessary - an approach that could spare the large majority of medical abortion clients who have uncomplicated courses an extra trip to the clinic There are in addition several less-expensive and less technology-intensive approaches to gathering the diagnostic information currently being provided pre- and post-procedure by ultrasonography
The purpose of the current study is to test the feasibility and efficacy of an approach to medical abortion that forgoes the routine use of ultrasonography It will also provide evidence on the feasibility of eliminating the requirement for a universal follow-up visit based on self-screening by medical abortion clients In providing data to make these tests however the study protocol will not in any way abridge the medical abortion care currently received by clients at the participating facilities The study will permit clients to receive standard care including a follow-up visit and pre- and post-procedure ultrasound examinations in all cases while gathering valuable information which we hope will provide a basis for simplifying standard care in the future
The research questions to be answered by the study are
1 Do an interview with the abortion client a pregnancy test and a physical exam provide adequate information to determine which abortion clients are eligible for the medical abortion procedure and which should be referred for sonography or other diagnostic tests before making such a determination
2 Can a self-administered symptom diary and a follow-up low-sensitivity pregnancy test provide an adequate basis to determine whether a woman has undergone a successful medical abortion or whether she requires a sonographic exam or other diagnostic test in order to make this determination
3 Does a post-abortion pelvic examination provide valuable additional information for determining whether a woman has undergone a successful medical abortion or whether she requires a sonographic exam or other diagnostic test in order to make this determination
4 Can a self-administered symptom diary and a low-sensitivity pregnancy test provide an adequate basis for determining which medical abortion clients require a follow-up visit
The research hypotheses are
1 Practitioners themselves based on history and examination but without sonography are able to dependably and correctly determine which patients are eligible for medical abortion and which patients either are not eligible or require further evaluation to determine eligibility
2 Practitioners themselves based on a symptom diary and low-sensitivity pregnancy test but without sonography are able to dependably and correctly determine when a successful medical abortion has taken place and when referral for other possible outcomes should be made
3 A symptom diary and low-sensitivity pregnancy test are safe and effective means of separating those women who could benefit from a follow-up visit from those who do not need one
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None