First Trimester AbortionNCT02756403
A Randomized Controlled Trial of Three Antibiotic Regimens for First Trimester Abortions
A study testing Azithromycin, Doxycycline and Metronidazole in people with First Trimester Abortion, run by Medstar Health Research Institute at 2 sites in United States.
Trial summary
This study, a double blinded randomized controlled trial, is being done to compare side effects of commonly used antibiotic regimens prior to same day abortion procedures. In total, 180 pregnant women in their first trimester of pregnancy (5 0/6-13 6/7 weeks gestation) will be randomized to receive one of the three… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- First Trimester Abortion
- What is being tested?
- Azithromycin, Doxycycline and Metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women in good general health.
- English speaking.
- Age 18 or over.
- Seeking non-urgent surgical termination of pregnancy.
- Gestational age of 5 0/7 to 13 6/7 weeks, confirmed by sonogram.
Who cannot join
- Less than 18 years of age.
- Early pregnancy failure or fetal demise.
- Poor general health that would prevent one from tolerating the medication or surgical procedure.
- Intolerance, allergy, or contraindication to any of the study medications.
- Inability to tolerate oral intake due to current nausea or vomiting.
- Diagnosis of hyperemesis gravidarum with current pregnancy.
- Need of an urgent surgical abortion.
- Gestational age outside of 5-13 6/7 weeks by sonogram.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Planned Parenthood Metropolitan Washington
Silver Spring, Maryland, 20910
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Randomized Controlled Trial of Three Prophylactic Antibiotic Regimens for First Trimester Surgical Abortion
This study, a double blinded randomized controlled trial, is being done to compare side effects of commonly used antibiotic regimens prior to same day abortion procedures.
In total, 180 pregnant women in their first trimester of pregnancy (5 0/6-13 6/7 weeks gestation) will be randomized to receive one of the three commonly used antibiotics (azithromycin, doxycycline, metronidazole) for same day abortion procedures or placebo prior to their abortion procedure. Approximately, 30-60 mins after study drug administration, the procedure will be performed.
A sub-study will be completed on 40 women who consent to endometrial sampling and to have their blood drawn.
Read the detailed description
Main Study:
Women will be randomized to receive single oral doses of azithromycin 500 mg, doxycycline 200 mg, metronidazole 500 mg, or placebo. Computer-generated randomization will be used to assign participants to one of the four treatment arms. Women receiving placebo will receive antibiotic prophylaxis after completion of the study.
Both the participants and the investigators will be blinded as to the treatment group. This will be accomplished by placing the study medication inside opaque gelatin capsules. We will randomize participants by assigning them to the next of the sequentially numbered sealed opaque study packets, containing the gelatin capsules with study medication inside. A second envelope will be opened after completion of all study procedure and will only say if the participant received placebo, so that additional antibiotics can be given.
Participants will swallow the appropriate medication approximately 30-60 minutes prior to the surgical abortion (15-90 minutes range is acceptable). Study population will be all eligible patients undergoing surgical abortion in the first trimester at Washington Hospital Center and Planned Parenthood Metropolitan Washington. We will assess pain and side effects via written questionnaire at three different time points throughout the day, once at time of consent, before and after the procedure. Patients will be contacted within 1-2 weeks for follow-up and again pain and side effects will be assessed, as well.
Sub-study:
Forty (n=40) women will be recruited to undergo immediate post-procedure endometrial sampling. Sub-study patients will have a blood sample collected via venipuncture before leaving the procedure room, as well. No testing will be performed for participants receiving placebo.
The primary objective is to determine if the side effects associated with individual medications are more similar to placebo than the others.
The sub-study aims to explore our ability to identify bacteria within the uterine cavity. The objective is to assess the feasibility of identifying bacteria within the uterus after abortion.
- Conditions
- First Trimester Abortion
- Being tested
- Azithromycin, Doxycycline, Metronidazole, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
500 mg
DoxycyclineDrug
200 mg
MetronidazoleDrug
500 mg
PlaceboDrug
Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Active comparator | 500 mg of Azithromycin Receives: Drug: Azithromycin |
| Doxycycline | Active comparator | 200 mg of Doxycycline Receives: Drug: Doxycycline |
| Metronidazole | Active comparator | 500 mg of Metronidazole Receives: Drug: Metronidazole |
| Placebo | Placebo comparator | Inactive Ingredient Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea Scale
Nausea symptom was collected at different time points via surveys (None, Mild, Moderate, Severe)
Measured: 1 Day
Emesis Severity
Emesis severity assessment collected at different time points (None, Mild, Moderate, Severe)
Measured: 1 Day
Secondary outcomes (3)
Pain Scale
Pain symptoms will be collected at different time points via surveys (None, Mild, Moderate, Severe)
Measured: Day 1
Serum Antibiotic Levels
Serum antibiotic levels drawn at time of endometrial sampling in subset of patients
Measured: 3 hours
Endometrial Growth
Endometrial Growth on non-selective, Staph Selective, Strep Selective, and Gram negative selective Agar
Measured: 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for First Trimester AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756403
- Sponsor's protocol ID
- 2015-159
- Status last verified
- Feb 2022
- First submitted
- 20 Mar 2016
- Last updated
- 11 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Three Prophylactic Antibiotic Regimens for First Trimester Surgical Abortion
- ClinicalTrials.gov ID
- NCT02756403
- Acronym / sponsor ID
- 2015-159
- Conditions
- First Trimester Abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Mar 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Posted 11 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study, a double blinded randomized controlled trial, is being done to compare side effects of commonly used antibiotic regimens prior to same day abortion procedures.
In total, 180 pregnant women in their first trimester of pregnancy (5 0/6-13 6/7 weeks gestation) will be randomized to receive one of the three commonly used antibiotics (azithromycin, doxycycline, metronidazole) for same day abortion procedures or placebo prior to their abortion procedure. Approximately, 30-60 mins after study drug administration, the procedure will be performed.
A sub-study will be completed on 40 women who consent to endometrial sampling and to have their blood drawn.
Detailed description
Main Study:
Women will be randomized to receive single oral doses of azithromycin 500 mg, doxycycline 200 mg, metronidazole 500 mg, or placebo. Computer-generated randomization will be used to assign participants to one of the four treatment arms. Women receiving placebo will receive antibiotic prophylaxis after completion of the study.
Both the participants and the investigators will be blinded as to the treatment group. This will be accomplished by placing the study medication inside opaque gelatin capsules. We will randomize participants by assigning them to the next of the sequentially numbered sealed opaque study packets, containing the gelatin capsules with study medication inside. A second envelope will be opened after completion of all study procedure and will only say if the participant received placebo, so that additional antibiotics can be given.
Participants will swallow the appropriate medication approximately 30-60 minutes prior to the surgical abortion (15-90 minutes range is acceptable). Study population will be all eligible patients undergoing surgical abortion in the first trimester at Washington Hospital Center and Planned Parenthood Metropolitan Washington. We will assess pain and side effects via written questionnaire at three different time points throughout the day, once at time of consent, before and after the procedure. Patients will be contacted within 1-2 weeks for follow-up and again pain and side effects will be assessed, as well.
Sub-study:
Forty (n=40) women will be recruited to undergo immediate post-procedure endometrial sampling. Sub-study patients will have a blood sample collected via venipuncture before leaving the procedure room, as well. No testing will be performed for participants receiving placebo.
The primary objective is to determine if the side effects associated with individual medications are more similar to placebo than the others.
The sub-study aims to explore our ability to identify bacteria within the uterine cavity. The objective is to assess the feasibility of identifying bacteria within the uterus after abortion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Active comparator | Drug: Azithromycin500 mg of Azithromycin |
| Doxycycline | Active comparator | Drug: Doxycycline200 mg of Doxycycline |
| Metronidazole | Active comparator | Drug: Metronidazole500 mg of Metronidazole |
| Placebo | Placebo comparator | Drug: PlaceboInactive Ingredient |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women in good general health.
- English speaking.
- Age 18 or over.
- Seeking non-urgent surgical termination of pregnancy.
- Gestational age of 5 0/7 to 13 6/7 weeks, confirmed by sonogram.
Key exclusion criteria (8 listed)
- Less than 18 years of age.
- Early pregnancy failure or fetal demise.
- Poor general health that would prevent one from tolerating the medication or surgical procedure.
- Intolerance, allergy, or contraindication to any of the study medications.
- Inability to tolerate oral intake due to current nausea or vomiting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin500 mg | Drug | Azithromycin |
| Doxycycline200 mg | Drug | Doxycycline |
| Metronidazole500 mg | Drug | Metronidazole |
| PlaceboPlacebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration. | Drug | Placebo |
Primary outcome
Nausea Scale
Time frame: 1 Day
Nausea symptom was collected at different time points via surveys (None, Mild, Moderate, Severe)
Emesis Severity
Time frame: 1 Day
Emesis severity assessment collected at different time points (None, Mild, Moderate, Severe)
3 secondary outcomes
Pain Scale
Time frame: Day 1
Serum Antibiotic Levels
Time frame: 3 hours
Endometrial Growth
Time frame: 3 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Azithromycin, Doxycycline and Metronidazole in people with First Trimester Abortion, run by Medstar Health Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nausea Scale (time frame: 1 Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.