EndometritisPhase 4Tu Du DoxyNCT00547170
Doxycycline Prophylaxis at Vacuum Aspiration Trial
A Phase 4 study testing Doxycycline pre-operatively and Doxycycline post-operatively in people with Endometritis, run by University of Pittsburgh at 1 site in Vietnam.
Trial summary
This study is a randomized, double-blinded, controlled trial comparing two regimens of doxycycline for the prevention of infection after surgical abortion. One thousand women undergoing surgical abortion in the first trimester will be enrolled from the clinic at Tu Du Hospital, Ho Chi Minh City, Vietnam. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometritis
- What is being tested?
- Doxycycline pre-operatively and Doxycycline post-operatively
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteVietnam
- Study dates
- Jan 2007to Mar 2008
- Phase
- Phase 4
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women seeking elective surgical abortion
- Gestational age 6 weeks 0 days to 12 weeks 6 days, confirmed by ultrasound.
- Willing and able to sign an informed consent.
- Willing to comply with the study protocol.
- Age at enrollment of 18 years or more.
Who cannot join
- Allergy to doxycycline or any tetracycline
- Evidence of current pelvic infection
- Breastfeeding
- Current or recent use (within the past 7 days) of any other antibiotic.
- Prior cardiac valve surgery or cardiac valve replacement.
- Active use of alcohol, heroin, or cocaine.
- Post-enrollment Exclusion criteria
- 1) Abortion procedure not performed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Side-Effects of Two Dosing Regimens of Doxycycline at Surgical Abortion: A Randomized Double-Blind Trial
This study is a randomized, double-blinded, controlled trial comparing two regimens of doxycycline for the prevention of infection after surgical abortion. One thousand women undergoing surgical abortion in the first trimester will be enrolled from the clinic at Tu Du Hospital, Ho Chi Minh City, Vietnam. The standard regimen has been 100 mg twice daily for 5 days after the abortion. Subjects will be randomized to the standard regimen or to take 200 mg doxycycline pre-operatively. Subjects found to have a positive Chlamydia EIA test will receive a 7-day course of doxycycline regardless of study group. Subjects will complete questionnaires of symptoms, including nausea and emesis in the recovery room after the procedure and at a single follow-up visit two weeks later. The primary outcome will be infection after abortion, defined below. Analyses will be performed including and excluding Chlamydia-positive subjects. Secondary outcomes will be the proportion with nausea, emesis, and other side-effects.
- Conditions
- Endometritis
- Being tested
- Doxycycline pre-operatively, Doxycycline post-operatively
- Keywords
- pelvic infection, abortion, doxycycline
- Medical subject headings
- Endometritis, Pelvic Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxycycline pre-operativelyDrug
Two capsules of Doxycycline 100 mg before vacuum aspiration Placebo "100 mg" twice daily for 5 days after vacuum aspiration (appearance of capsules is the same for both groups)
Doxycycline post-operativelyDrug
Two capsules of placebo "100 mg" before vacuum aspiration Doxycycline 100 mg twice daily for 5 days after vacuum aspiration (appearance of capsules is the same for both groups)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Half of enrolled women will be randomly assigned to group 1. Receives: Drug: Doxycycline pre-operatively |
| 2 | Active comparator | Half of enrolled women will be randomly assigned to group 2 Receives: Drug: Doxycycline post-operatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection
Measured: 2 weeks
Secondary outcomes (2)
nausea and emesis
Measured: 2 weeks
compliance (completion of study medication)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
- Study startJan 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometritisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Tu Du Hospital
- Investigators
- Matthew F Reeves, MD, Principal investigator, University of PittsburghLoi T Tran, MD, Study director, Tu Du Hospital, Ho Chi Minh City, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547170
- Sponsor's protocol ID
- PRO06040005
- Acronym
- Tu Du Doxy
- Status last verified
- May 2008
- First submitted
- 19 Oct 2007
- Last updated
- 16 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Side-Effects of Two Dosing Regimens of Doxycycline at Surgical Abortion: A Randomized Double-Blind Trial
- ClinicalTrials.gov ID
- NCT00547170
- Acronym / sponsor ID
- Tu Du Doxy / PRO06040005
- Conditions
- Endometritis
- Keywords
- pelvic infection, abortion, doxycycline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Tu Du Hospital
- Study start
- Jan 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 22 Oct 2007 (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.
This study is a randomized, double-blinded, controlled trial comparing two regimens of doxycycline for the prevention of infection after surgical abortion. One thousand women undergoing surgical abortion in the first trimester will be enrolled from the clinic at Tu Du Hospital, Ho Chi Minh City, Vietnam. The standard regimen has been 100 mg twice daily for 5 days after the abortion. Subjects will be randomized to the standard regimen or to take 200 mg doxycycline pre-operatively. Subjects found to have a positive Chlamydia EIA test will receive a 7-day course of doxycycline regardless of study group. Subjects will complete questionnaires of symptoms, including nausea and emesis in the recovery room after the procedure and at a single follow-up visit two weeks later. The primary outcome will be infection after abortion, defined below. Analyses will be performed including and excluding Chlamydia-positive subjects. Secondary outcomes will be the proportion with nausea, emesis, and other side-effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Doxycycline pre-operativelyHalf of enrolled women will be randomly assigned to group 1. |
| 2 | Active comparator | Drug: Doxycycline post-operativelyHalf of enrolled women will be randomly assigned to group 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women seeking elective surgical abortion
- Gestational age 6 weeks 0 days to 12 weeks 6 days, confirmed by ultrasound.
- Willing and able to sign an informed consent.
- Willing to comply with the study protocol.
- Age at enrollment of 18 years or more.
Key exclusion criteria (8 listed)
- Allergy to doxycycline or any tetracycline
- Evidence of current pelvic infection
- Breastfeeding
- Current or recent use (within the past 7 days) of any other antibiotic.
- Prior cardiac valve surgery or cardiac valve replacement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxycycline pre-operativelyTwo capsules of Doxycycline 100 mg before vacuum aspiration Placebo "100 mg" twice daily for 5 days after vacuum aspiration (appearance of capsules is the same for both groups) | Drug | 1 |
| Doxycycline post-operativelyTwo capsules of placebo "100 mg" before vacuum aspiration Doxycycline 100 mg twice daily for 5 days after vacuum aspiration (appearance of capsules is the same for both groups) | Drug | 2 |
Primary outcome
Infection
Time frame: 2 weeks
2 secondary outcomes
nausea and emesis
Time frame: 2 weeks
compliance (completion of study medication)
Time frame: 5 days
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 16 May 2008.
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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.
Matthew F Reeves, MD principal investigator
University of Pittsburgh
Loi T Tran, MD study director
Tu Du Hospital, Ho Chi Minh City, Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxycycline pre-operatively and Doxycycline post-operatively in people with Endometritis, run by University of Pittsburgh at 1 site in Vietnam.
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 5 inclusion and 8 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 16 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Infection (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2008.