AbortionNCT01799252
Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion
An observational study of Abortion, run by Gynuity Health Projects at 7 sites in United States.
Trial summary
The effectiveness of antibiotic treatment at reducing post-abortion infection is unclear. The experiences of women prescribed routine antibiotics after medical abortion is missing from the existing evidence. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion
- How many people
- 582 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study will enroll 610 women. Women will be recruited from 5 clinics and will self-administer, or if necessary, a study coordinator will administer, a computer-based questionnaire 7-14 days following administration of mifepristone.
Who may be able to join
- Women who are having MA at the study clinic and are willing to complete a self-administered, computer-based questionnaire 7-14 days after taking mifepristone
- Women who can read English or Spanish
- In the doxycycline arm: Women who have been prescribed doxycycline
Who cannot join
- Women who were treated with antibiotics for a medical condition unrelated to their medical abortion between the initial visit and follow-up appointment
- Women who have previously enrolled in this study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Planned Parenthood Mid and South Michigan
Ann Arbor, Michigan, 48104
Feminist Women's Health Center
Atlanta, Georgia, 30329
Family Planning Associates
Chicago, Illinois, 60630
Family Practice and Sidney Hillman Family Practice at the Institute for Family Health
New York, New York, 10003
NYU/Bellevue Hospital Center, Women's Health Center
New York, New York, 10016
Cedar River Clinic
Renton, Washington, 98057
Planned Parenthood MN, ND, SD
Saint Paul, Minnesota, 55114
About this study
The effectiveness of antibiotic treatment at reducing post-abortion infection is unclear. The experiences of women prescribed routine antibiotics after medical abortion is missing from the existing evidence. This study seeks to add to the literature evidence of the side effects associated with antibiotic treatment that women experience and their adherence to prescribed regimens.
Read the detailed description
Medical abortion (MA) consists of administering medication, typically a combination of mifepristone and misoprostol, to induce an abortion without any invasive procedures. Early first trimester MA is effective1, highly acceptable to women, and safe. The risk of infection following medical abortion is small, at less than 1%. In rare circumstances, pelvic infection with clostridia bacteria following medical abortion has resulted in death. Since 2000, when mifepristone was registered in the United States, 8 such deaths have been recorded in the US.
Following the publication of case reports of four clostridium-associated deaths after medical abortion in 2005, the reproductive health community reacted swiftly. Medical abortion protocols were altered in an effort to curb these drastic and rapidly fatal infections. Antibiotic treatment, typically a seven-day course of doxycycline, has become widespread in the United States.
The effectiveness of antibiotic treatment at reducing post-abortion infection is unclear. The experiences of women prescribed routine antibiotics after medical abortion is missing from the existing evidence. This study seeks to add to the literature evidence of the side effects associated with antibiotic treatment that women experience and their adherence to prescribed regimens.
- Conditions
- Abortion
- Keywords
- medical abortion, doxycycline, antibiotics, adherence, nausea
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Doxy | Women who are prescribed a seven-day regimen of doxycycline following medical abortion | |
| No Doxy | Women who are not prescribed antibiotics following medical abortion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rates of nausea
Compare the incidence rates of nausea between women who are prescribed a seven-day regimen of doxycycline to women who are not prescribed antibiotics following medical abortion
Measured: 7-14 days following medical abortion
adherence
Document the self-reported adherence to antibiotic regimens following medical abortion
Measured: 7-14 days following medical abortion
Secondary outcomes (4)
Nausea rates
Compare the rates of nausea between women who take at least one doxycycline pill to women who do not take any doxycycline following medical abortion
Measured: 7-14 days following medical abortion
Non-nausea side effects
Compare the rates of other (non-nausea) side effects between women who are prescribed a seven-day regimen of doxycycline to women who are not prescribed antibiotics following medical abortion
Measured: 7-14 days following medical abortion
Additional medications
Compare the use of additional medication to treat side effects between women who take antibiotics and women who do not take antibiotics following medical abortion
Measured: 7-14 days following medical abortion
Cost
Document the cost to women of antibiotics regimens following medical abortion
Measured: at time of filling prescription
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799252
- Sponsor's protocol ID
- 7000
- Status last verified
- Jan 2014
- First submitted
- 7 Dec 2012
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Frye LJ, Chong E, Winikoff B; NCT01799252 Trial Investigators. What happens when we routinely give doxycycline to medical abortion patients? Contraception. 2015 Jan;91(1):19-24. doi: 10.1016/j.contraception.2014.09.001. Epub 2014 Sep 15.
PubMed 25444253
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion
- ClinicalTrials.gov ID
- NCT01799252
- Acronym / sponsor ID
- 7000
- Conditions
- Abortion
- Keywords
- medical abortion, doxycycline, antibiotics, adherence, nausea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effectiveness of antibiotic treatment at reducing post-abortion infection is unclear. The experiences of women prescribed routine antibiotics after medical abortion is missing from the existing evidence. This study seeks to add to the literature evidence of the side effects associated with antibiotic treatment that women experience and their adherence to prescribed regimens.
Detailed description
Medical abortion (MA) consists of administering medication, typically a combination of mifepristone and misoprostol, to induce an abortion without any invasive procedures. Early first trimester MA is effective1, highly acceptable to women, and safe. The risk of infection following medical abortion is small, at less than 1%. In rare circumstances, pelvic infection with clostridia bacteria following medical abortion has resulted in death. Since 2000, when mifepristone was registered in the United States, 8 such deaths have been recorded in the US.
Following the publication of case reports of four clostridium-associated deaths after medical abortion in 2005, the reproductive health community reacted swiftly. Medical abortion protocols were altered in an effort to curb these drastic and rapidly fatal infections. Antibiotic treatment, typically a seven-day course of doxycycline, has become widespread in the United States.
The effectiveness of antibiotic treatment at reducing post-abortion infection is unclear. The experiences of women prescribed routine antibiotics after medical abortion is missing from the existing evidence. This study seeks to add to the literature evidence of the side effects associated with antibiotic treatment that women experience and their adherence to prescribed regimens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxy | – | –Women who are prescribed a seven-day regimen of doxycycline following medical abortion |
| No Doxy | – | –Women who are not prescribed antibiotics following medical abortion |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will enroll 610 women. Women will be recruited from 5 clinics and will self-administer, or if necessary, a study coordinator will administer, a computer-based questionnaire 7-14 days following administration of mifepristone.
Key inclusion criteria (3 listed)
- Women who are having MA at the study clinic and are willing to complete a self-administered, computer-based questionnaire 7-14 days after taking mifepristone
- Women who can read English or Spanish
- In the doxycycline arm: Women who have been prescribed doxycycline
Key exclusion criteria (2 listed)
- Women who were treated with antibiotics for a medical condition unrelated to their medical abortion between the initial visit and follow-up appointment
- Women who have previously enrolled in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence rates of nausea
Time frame: 7-14 days following medical abortion
Compare the incidence rates of nausea between women who are prescribed a seven-day regimen of doxycycline to women who are not prescribed antibiotics following medical abortion
adherence
Time frame: 7-14 days following medical abortion
Document the self-reported adherence to antibiotic regimens following medical abortion
4 secondary outcomes
Nausea rates
Time frame: 7-14 days following medical abortion
Non-nausea side effects
Time frame: 7-14 days following medical abortion
Additional medications
Time frame: 7-14 days following medical abortion
Cost
Time frame: at time of filling prescription
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
- Derived from this study: PubMed 25444253Frye LJ, Chong E, Winikoff B; NCT01799252 Trial Investigators. What happens when we routinely give doxycycline to medical abortion patients? Contraception. 2015 Jan;91(1):19-24. doi: 10.1016/j.contraception.2014.09.001. Epub 2014 Sep 15.
- Sponsor websiteLink provided by the sponsor.
Related trials for Abortion
Recruiting
Effect of Intrauterine Insemination on Subsequent Pregnancy Outcomes in Couples With Unexplained Pregnancy Loss: A Multicenter, Open-label, Randomized Controlled Trial
Unexplained Pregnancy Loss
Recruiting
High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety
Recurrent Pregnancy Loss(RPL), Anxiety
Not yet recruitingObservational study
Cervical Length Reference Range at 28-34 Weeks in Singleton Pregnancies
Preterm Birth, Cervical Length
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Not yet recruiting
e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
Depressive Symptoms, Perinatal Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion, run by Gynuity Health Projects at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rates of nausea (time frame: 7-14 days following medical abortion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01799252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2014.