Doxycycline Prophylaxis at Vacuum Aspiration Trial - Tabular View

Tracking Information

First Received Date ^ICMJE

October 19, 2007

Last Updated Date

May 14, 2008

Start Date ^ICMJE

January 2007

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Infection [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Infection [ Time Frame: 2 weeks ]

Change History

Complete list of historical versions of study NCT00547170 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

nausea and emesis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
compliance (completion of study medication) [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

nausea and emesis [ Time Frame: 2 weeks ]
compliance (completion of study medication) [ Time Frame: 5 days ]

Descriptive Information

Brief Title ^ICMJE

Doxycycline Prophylaxis at Vacuum Aspiration Trial

Official Title ^ICMJE

Efficacy and Side-Effects of Two Dosing Regimens of Doxycycline at Surgical Abortion: A Randomized Double-Blind Trial

Brief 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. 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Endometritis

Intervention ^ICMJE

Drug: Doxycycline pre-operatively
Drug: Doxycycline post-operatively

Study Arms / Comparison Groups

Experimental: Half of enrolled women will be randomly assigned to group 1.
Active Comparator: Half of enrolled women will be randomly assigned to group 2

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1000

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria.

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.

Exclusion criteria

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Vietnam

Administrative Information

NCT ID ^ICMJE

NCT00547170

Responsible Party

Matthew Reeves, University of Pittsburgh

Study ID Numbers ^ICMJE

PRO06040005

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

Tu Du Hospital

Investigators ^ICMJE

Principal Investigator:	Matthew F Reeves, MD	University of Pittsburgh
Study Director:	Loi T Tran, MD	Tu Du Hospital, Ho Chi Minh City, Vietnam

Information Provided By

University of Pittsburgh

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP