Abortion, InducedPhase 4NCT00177333
Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens
A Phase 4 study testing Doxycycline in people with Abortion, Induced and Vomiting, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is a randomized double-blind, controlled trial comparing two regimens of pre-abortion doxycycline. The aims of the study are to determine the serum levels of doxycycline when administered pre-operatively 4 hours or approximately 18 hours before a dilation and evacuation (D \& E) abortion. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Induced, Vomiting
- What is being tested?
- Doxycycline
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to May 2006
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gestational age 15-23 weeks by ultrasound.
- Willing and able to sign an informed consent.
- Placement of cervical dilators. Dilators must be placed before giving any subject doxycycline in order to ensure that all subjects who receive doxycycline will have an abortion.
- Willing to comply with the study protocol.
- Age at enrollment of 18 years or more.
Who cannot join
- Need for an urgent D \& E. Indications for this include ruptured membranes, advanced cervical dilation, infection, and fetal demise.
- Allergy to doxycycline or any tetracycline
- Exposure to or treatment for gonorrhea or chlamydia within the past 90 days.
- Current or recent (within the past week) use of any other antibiotic.
- Prior cardiac valve surgery or cardiac valve replacement. These patients should all receive alternative antibiotics for endocarditis prophylaxis.
- Active use of alcohol, heroin, or cocaine. Active use of alcohol will be defined as more than 2 drinks per day. Any use of heroin or cocaine will be considered exclusionary.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
This is a randomized double-blind, controlled trial comparing two regimens of pre-abortion doxycycline. The aims of the study are to determine the serum levels of doxycycline when administered pre-operatively 4 hours or approximately 18 hours before a dilation and evacuation (D \& E) abortion. The hypotheses being tested are that subjects who receive doxycycline with food the night before an abortion will have adequate serum levels, but less nausea and vomiting compared to women who take the doxycycline on an empty stomach on the morning of the abortion. Subjects will either take 200mg doxycycline on the night before and 2 caps placebo with a sip of water on the morning of surgery or 2 caps placebo the night before and 200mg doxycycline on the morning of surgery with a sip of water. All capsules will look identical. Diaries, questionnaires and a 10cc sample of blood for doxycycline levels will be collected from the subjects at the time of surgery.
Read the detailed description
This is a randomized double-blind, controlled trial comparing two regimens of pre-abortion doxycycline. The aims of the study are to determine the serum levels of doxycycline when administered pre-operatively 4 hours or approximately 18 hours before a dilation and evacuation (D \& E) abortion. The hypotheses being tested are that subjects who receive doxycycline with food the night before an abortion will have adequate serum levels, but less nausea and vomiting compared to women who take the doxycycline on an empty stomach on the morning of the abortion. Subjects will either take 200mg doxycycline on the night before and 2 caps placebo with a sip of water on the morning of surgery or 2 caps placebo the night before and 200mg doxycycline on the morning of surgery with a sip of water. All capsules will look identical. Diaries, questionnaires and a 10cc sample of blood for doxycycline levels will be collected from the subjects at the time of surgery.
- Conditions
- Abortion, Induced, Vomiting
- Being tested
- Doxycycline
- Keywords
- Abortion, Induced, Doxycycline, Antibiotic Prophylaxis, Vomiting, Abortion, Therapeutic
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
doxycycline side effects
Measured: 24 hours
Secondary outcomes (3)
nausea
Measured: 24 hours
vomiting
Measured: 24 hours
other side effects
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionMay 2006
- Study completionMay 2006
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 Abortion, InducedStudies 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
- Double blind
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M Reeves, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177333
- Sponsor's protocol ID
- pittirb0504092
- Status last verified
- Jan 2016
- First submitted
- 12 Sep 2005
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Reeves MF, Lohr PA, Harwood BJ, Creinin MD. Ultrasonographic endometrial thickness after medical and surgical management of early pregnancy failure. Obstet Gynecol. 2008 Jan;111(1):106-12. doi: 10.1097/01.AOG.0000296655.26362.6d.
PubMed 18165398
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens
- ClinicalTrials.gov ID
- NCT00177333
- Acronym / sponsor ID
- pittirb0504092
- Conditions
- Abortion, Induced, Vomiting
- Keywords
- Abortion, Induced, Doxycycline, Antibiotic Prophylaxis, Vomiting, Abortion, Therapeutic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 15 Sep 2005 (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 is a randomized double-blind, controlled trial comparing two regimens of pre-abortion doxycycline. The aims of the study are to determine the serum levels of doxycycline when administered pre-operatively 4 hours or approximately 18 hours before a dilation and evacuation (D \& E) abortion. The hypotheses being tested are that subjects who receive doxycycline with food the night before an abortion will have adequate serum levels, but less nausea and vomiting compared to women who take the doxycycline on an empty stomach on the morning of the abortion. Subjects will either take 200mg doxycycline on the night before and 2 caps placebo with a sip of water on the morning of surgery or 2 caps placebo the night before and 200mg doxycycline on the morning of surgery with a sip of water. All capsules will look identical. Diaries, questionnaires and a 10cc sample of blood for doxycycline levels will be collected from the subjects at the time of surgery.
Detailed description
This is a randomized double-blind, controlled trial comparing two regimens of pre-abortion doxycycline. The aims of the study are to determine the serum levels of doxycycline when administered pre-operatively 4 hours or approximately 18 hours before a dilation and evacuation (D \& E) abortion. The hypotheses being tested are that subjects who receive doxycycline with food the night before an abortion will have adequate serum levels, but less nausea and vomiting compared to women who take the doxycycline on an empty stomach on the morning of the abortion. Subjects will either take 200mg doxycycline on the night before and 2 caps placebo with a sip of water on the morning of surgery or 2 caps placebo the night before and 200mg doxycycline on the morning of surgery with a sip of water. All capsules will look identical. Diaries, questionnaires and a 10cc sample of blood for doxycycline levels will be collected from the subjects at the time of surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Gestational age 15-23 weeks by ultrasound.
- Willing and able to sign an informed consent.
- Placement of cervical dilators. Dilators must be placed before giving any subject doxycycline in order to ensure that all subjects who receive doxycycline will have an abortion.
- Willing to comply with the study protocol.
- Age at enrollment of 18 years or more.
Key exclusion criteria (6 listed)
- Need for an urgent D \& E. Indications for this include ruptured membranes, advanced cervical dilation, infection, and fetal demise.
- Allergy to doxycycline or any tetracycline
- Exposure to or treatment for gonorrhea or chlamydia within the past 90 days.
- Current or recent (within the past week) use of any other antibiotic.
- Prior cardiac valve surgery or cardiac valve replacement. These patients should all receive alternative antibiotics for endocarditis prophylaxis.
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 | Drug | – |
Primary outcome
doxycycline side effects
Time frame: 24 hours
3 secondary outcomes
nausea
Time frame: 24 hours
vomiting
Time frame: 24 hours
other side effects
Time frame: 24 hours
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 29 Jan 2016.
- Derived from this study: PubMed 18165398Reeves MF, Lohr PA, Harwood BJ, Creinin MD. Ultrasonographic endometrial thickness after medical and surgical management of early pregnancy failure. Obstet Gynecol. 2008 Jan;111(1):106-12. doi: 10.1097/01.AOG.0000296655.26362.6d.
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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.
M Reeves, MD principal investigator
University of Pittsburgh
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 in people with Abortion, Induced and Vomiting, run by University of Pittsburgh at 1 site 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 5 inclusion and 6 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 29 Jan 2016. 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 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.
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?
doxycycline side effects (time frame: 24 hours). 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 NCT00177333, 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 29 Jan 2016.