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CompletedNCT00177333Updated Jan 29, 2016

Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens

A Phase 4 interventional study of Doxycycline in Abortion, Induced and Vomiting, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-29.

Sponsored by University of Pittsburgh · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

This is a randomized double-blind, controlled trial comparing two regimens of pre-abortion doxycycline. The aims of the study are to determine the serum levels of doxycycline when administered pre-operatively 4 hours or approximately 18 hours before a dilation and evacuation (D \& E) abortion. The hypotheses being tested are that subjects who receive doxycycline with food the night before an abortion will have adequate serum levels, but less nausea and vomiting compared to women who take the doxycycline on an empty stomach on the morning of the abortion. Subjects will either take 200mg doxycycline on the night before and 2 caps placebo with a sip of water on the morning of surgery or 2 caps placebo the night before and 200mg doxycycline on the morning of surgery with a sip of water. All capsules will look identical. Diaries, questionnaires and a 10cc sample of blood for doxycycline levels will be collected from the subjects at the time of surgery.

Read the detailed description

This is a randomized double-blind, controlled trial comparing two regimens of pre-abortion doxycycline. The aims of the study are to determine the serum levels of doxycycline when administered pre-operatively 4 hours or approximately 18 hours before a dilation and evacuation (D \& E) abortion. The hypotheses being tested are that subjects who receive doxycycline with food the night before an abortion will have adequate serum levels, but less nausea and vomiting compared to women who take the doxycycline on an empty stomach on the morning of the abortion. Subjects will either take 200mg doxycycline on the night before and 2 caps placebo with a sip of water on the morning of surgery or 2 caps placebo the night before and 200mg doxycycline on the morning of surgery with a sip of water. All capsules will look identical. Diaries, questionnaires and a 10cc sample of blood for doxycycline levels will be collected from the subjects at the time of surgery.

02

Conditions studied

  • Abortion, Induced
  • Vomiting

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Keywords

  • Abortion, Induced
  • Doxycycline
  • Antibiotic Prophylaxis
  • Vomiting
  • Abortion, Therapeutic
03

In context

Vomiting

1,123 studies on the registry are indexed under Vomiting; 137 are open to participants now.

This study's enrollment of 40 is below the median of 105 across 954 interventional studies indexed under Vomiting.

Browse Vomiting studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Gestational age 15-23 weeks by ultrasound.
  2. Willing and able to sign an informed consent.
  3. Placement of cervical dilators. Dilators must be placed before giving any subject doxycycline in order to ensure that all subjects who receive doxycycline will have an abortion.
  4. Willing to comply with the study protocol.
  5. Age at enrollment of 18 years or more.

Exclusion criteria

Exclusion Criteria:

  1. Need for an urgent D \& E. Indications for this include ruptured membranes, advanced cervical dilation, infection, and fetal demise.
  2. Allergy to doxycycline or any tetracycline
  3. Exposure to or treatment for gonorrhea or chlamydia within the past 90 days.
  4. Current or recent (within the past week) use of any other antibiotic.
  5. Prior cardiac valve surgery or cardiac valve replacement. These patients should all receive alternative antibiotics for endocarditis prophylaxis.
  6. Active use of alcohol, heroin, or cocaine. Active use of alcohol will be defined as more than 2 drinks per day. Any use of heroin or cocaine will be considered exclusionary.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
40 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. doxycycline side effects

    Time frame: 24 hours

Secondary outcomes

  1. nausea

    Time frame: 24 hours

  2. vomiting

    Time frame: 24 hours

  3. other side effects

    Time frame: 24 hours

07

Study locations

1 site
  • Magee-Womens Hospital
    Pittsburgh, Pennsylvania 15213, United States
08

References and documents

Publications

  • Reeves MF, Lohr PA, Harwood BJ, Creinin MD. Ultrasonographic endometrial thickness after medical and surgical management of early pregnancy failure. Obstet Gynecol. 2008 Jan;111(1):106-12. doi: 10.1097/01.AOG.0000296655.26362.6d. PubMed 18165398 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2005, a primary completion of May 2006 and a completion of May 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2005
First posted
Sep 15, 2005
Start
Sep 2005
Primary completionActual
May 2006
CompletionActual
May 2006
Last update
Jan 29, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00177333
Responsible party
Sponsor
First posted
Sep 15, 2005
Start date
Sep 2005
Primary completion
May 2006
Completion
May 2006
Last update
Jan 29, 2016

Study contacts

M Reeves, MD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Doxycycline

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