Skip to main content
OpenTrials
Completed

NCT Number: NCT00547170

Doxycycline Prophylaxis at Vacuum Aspiration Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Tu Du Hospital

Ho Chi Minh City, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Abortion procedure not performed

Treatment and study plan

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)

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)

Primary outcomes

  1. Infection

    Time frame: 2 weeks

Secondary outcomes

  1. nausea and emesis

    Time frame: 2 weeks

  2. compliance (completion of study medication)

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Tu Du Hospital

Registry information

Official study title

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

Acronym: Tu Du Doxy

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 22, 2007
Registry last updated
May 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.