IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Doxycycline Prophylaxis at Vacuum Aspiration Trial (Tu Du Doxy)
This study has been completed.
Sponsor:
University of Pittsburgh
Collaborator:
Tu Du Hospital
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00547170
First received: October 19, 2007
Last updated: May 14, 2008
Last verified: May 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Endometritis | Drug: Doxycycline pre-operatively Drug: Doxycycline post-operatively | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Efficacy and Side-Effects of Two Dosing Regimens of Doxycycline at Surgical Abortion: A Randomized Double-Blind Trial |
Resource links provided by NLM:
MedlinePlus related topics:
Nausea and Vomiting
Drug Information available for:
Doxycycline
Doxycycline monohydrate
Doxycycline hyclate
Doxycycline calcium
U.S. FDA Resources
Further study details as provided by University of Pittsburgh:
Primary Outcome Measures:
- Infection [ Time Frame: 2 weeks ]
Secondary Outcome Measures:
- nausea and emesis [ Time Frame: 2 weeks ]
- compliance (completion of study medication) [ Time Frame: 5 days ]
| Enrollment: | 1000 |
| Study Start Date: | January 2007 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Half of enrolled women will be randomly assigned to group 1.
|
Drug: 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)
|
|
Active Comparator: 2
Half of enrolled women will be randomly assigned to group 2
|
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)
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547170
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547170
Locations
| Vietnam | |
| Tu Du Hospital | |
| Ho Chi Minh City, Vietnam | |
Sponsors and Collaborators
University of Pittsburgh
Tu Du Hospital
Investigators
| Principal Investigator: | Matthew F Reeves, MD | University of Pittsburgh |
| Study Director: | Loi T Tran, MD | Tu Du Hospital, Ho Chi Minh City, Vietnam |
More Information
| Responsible Party: | Matthew Reeves, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00547170 History of Changes |
| Other Study ID Numbers: |
PRO06040005 |
| Study First Received: | October 19, 2007 |
| Last Updated: | May 14, 2008 |
Keywords provided by University of Pittsburgh:
|
pelvic infection abortion doxycycline |
Additional relevant MeSH terms:
|
Pelvic Inflammatory Disease Adnexal Diseases Genital Diseases, Female Uterine Diseases Endometritis Doxycycline |
Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on June 22, 2017