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

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medstar Health Research Institute
• Collaborator: Society of Family Planning
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Azithromycin; Doxycycline; Metronidazole

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.