Back to resultsSerum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens
Primary Purpose
Abortion, Induced, Vomiting
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Doxycycline
Sponsored by
About this trial
This is an interventional prevention trial for Abortion, Induced focused on measuring Abortion, Induced, Doxycycline, Antibiotic Prophylaxis, Vomiting, Abortion, Therapeutic
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Magee-Womens Hospital
Outcomes
Primary Outcome Measures
doxycycline side effects
Secondary Outcome Measures
nausea
vomiting
other side effects
Full Information
NCT ID
NCT00177333
First Posted
September 12, 2005
Last Updated
January 28, 2016
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT00177333
Brief Title
Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens
Official Title
Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion, Induced, Vomiting
Keywords
Abortion, Induced, Doxycycline, Antibiotic Prophylaxis, Vomiting, Abortion, Therapeutic
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Primary Outcome Measure Information:
Title
doxycycline side effects
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
nausea
Time Frame
24 hours
Title
vomiting
Time Frame
24 hours
Title
other side effects
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Reeves, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18165398
Citation
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.
Results Reference
derived
Learn more about this trial
Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens
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