Doxycycline Prophylaxis at Vacuum Aspiration Trial

NCT00547170 | Completed Phase 4

• 1 other identifier: PRO06040005
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometritis

Keywords

pelvic infection; abortion; doxycycline

Outcome Measures

Primary Outcomes (1)

• Infection

  2 weeks

Secondary Outcomes (2)

• nausea and emesis

  2 weeks

• compliance (completion of study medication)

  5 days

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Doxycycline pre-operatively

2

ACTIVE COMPARATOR

Half of enrolled women will be randomly assigned to group 2

Drug: Doxycycline post-operatively

Interventions

Doxycycline pre-operatively 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)

1

Doxycycline post-operatively 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)

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \) Abortion procedure not performed

Sponsors & Collaborators

• University of Pittsburgh: lead
• Tu Du Hospital: collaborator

Study Sites (1)

Tu Du Hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Endometritis; Pelvic Infection

Condition Hierarchy (Ancestors)

Pelvic Inflammatory Disease; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Diseases; Genital Diseases; Infections

Study Officials

• Matthew F Reeves, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Loi T Tran, MD

  Tu Du Hospital, Ho Chi Minh City, Vietnam

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 19, 2007
• First Posted: October 22, 2007
• Study Start: January 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: May 16, 2008

Record last verified: 2008-05

Locations

VN (1)