Clinical trial NCT02756403: A Randomized Controlled Trial of Three Antibiotic Regimens for First Trimester Abortions
Official title: A Randomized Controlled Trial of Three Prophylactic Antibiotic Regimens for First Trimester Surgical Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: First Trimester Abortion
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2016-04-29
Enrollment: 181
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Nausea Scale
timeFrame: 1 Day
measure: Emesis Severity
timeFrame: 1 Day
Secondary outcomes:
measure: Pain Scale
timeFrame: Day 1
measure: Serum Antibiotic Levels
timeFrame: 3 hours
measure: Endometrial Growth
timeFrame: 3 Days
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Silver Spring
country: United States
facility: Planned Parenthood Metropolitan Washington
state: Maryland
Study officials:
References: