A Randomized Controlled Trial of Three Antibiotic Regimens for First Trimester Abortions

NCT ID: NCT02756403

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-07-31

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.

Conditions

First Trimester Abortion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Azithromycin

500 mg of Azithromycin

Group Type: ACTIVE_COMPARATOR

Azithromycin

Intervention Type: DRUG

500 mg

Doxycycline

200 mg of Doxycycline

Group Type: ACTIVE_COMPARATOR

Doxycycline

Intervention Type: DRUG

200 mg

Metronidazole

500 mg of Metronidazole

Group Type: ACTIVE_COMPARATOR

Metronidazole

Intervention Type: DRUG

500 mg

Placebo

Inactive Ingredient

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.

Interventions

Azithromycin

500 mg

Intervention Type: DRUG

Doxycycline

200 mg

Intervention Type: DRUG

Metronidazole

500 mg

Intervention Type: DRUG

Placebo

Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Planned Parenthood Metropolitan Washington

Silver Spring, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015-159

Identifier Type: -

Identifier Source: org_study_id