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Doxycycline Prophylaxis at Vacuum Aspiration Trial

NCT ID: NCT00547170

Last Updated: 2008-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-03-31

Brief Summary

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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

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Conditions

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Endometritis

Keywords

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pelvic infection abortion doxycycline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Half of enrolled women will be randomly assigned to group 1.

Group Type EXPERIMENTAL

Doxycycline pre-operatively

Intervention Type DRUG

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)

2

Half of enrolled women will be randomly assigned to group 2

Group Type ACTIVE_COMPARATOR

Doxycycline post-operatively

Intervention Type DRUG

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)

Interventions

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Doxycycline pre-operatively

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)

Intervention Type DRUG

Doxycycline post-operatively

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)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Women seeking elective surgical abortion
2. Gestational age 6 weeks 0 days to 12 weeks 6 days, confirmed by ultrasound.
3. Willing and able to sign an informed consent.
4. Willing to comply with the study protocol.
5. Age at enrollment of 18 years or more.

Exclusion Criteria

1. Allergy to doxycycline or any tetracycline
2. Evidence of current pelvic infection
3. Breastfeeding
4. Current or recent use (within the past 7 days) of any other antibiotic.
5. Prior cardiac valve surgery or cardiac valve replacement.
6. Active use of alcohol, heroin, or cocaine.


1\) Abortion procedure not performed
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tu Du Hospital

OTHER_GOV

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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University of Pittsburgh

Principal Investigators

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Matthew F Reeves, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Loi T Tran, MD

Role: STUDY_DIRECTOR

Tu Du Hospital, Ho Chi Minh City, Vietnam

Locations

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Tu Du Hospital

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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PRO06040005

Identifier Type: -

Identifier Source: org_study_id