Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens - Full Text View

Sponsors and Collaborators:	University of Pittsburgh An anonymous Foundation.
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00177333

Purpose

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.

Condition	Intervention	Phase
Abortion, Induced Vomiting	Drug: Doxycycline	Phase IV

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Doxycycline Doxycycline calcium Doxycycline hyclate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Bio-equivalence Study
Official Title:	Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

doxycycline side effects [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

nausea [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
other side effects [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	September 2005
Study Completion Date:	May 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177333

Locations

United States, Pennsylvania
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

An anonymous Foundation.

Investigators

Principal Investigator:

M Reeves, MD

University of Pittsburgh

More Information

University of Pittsburgh Center for Family Planning Research website This link exits the ClinicalTrials.gov site

Publications indexed to this study:

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.

Responsible Party:	University of Pittssburgh ( Matthew Reeves, MD, MPH )
Study ID Numbers:	pittirb0504092
Study First Received:	September 12, 2005
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00177333
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Abortion, Induced
Doxycycline
Antibiotic Prophylaxis
Vomiting
Abortion, Therapeutic

Study placed in the following topic categories:

Signs and Symptoms
Vomiting
Signs and Symptoms, Digestive
Doxycycline

Additional relevant MeSH terms:

Antimalarials
Anti-Infective Agents
Anti-Bacterial Agents
Antiparasitic Agents

Antiprotozoal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009