Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester Dilation and Evacuation Abortion

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Misoprostol is a medication used extensively in obstetrics and gynecology for its ability to aid in softening the cervix as well as decreasing blood loss after abortion or vaginal delivery. Opinions vary as to its usefulness in aiding in cervical dilation, and in decreasing blood loss. The investigators propose to conduct a randomized, placebo-controlled trial to evaluate whether misoprostol given buccally 2 hours prior to second trimester surgical abortion decreases blood loss from the procedure. The investigators will also assess whether misoprostol improves cervical dilation, changes the length of the procedure, changes the need for additional mechanical dilation, changes the subjective ease of the procedure, and changes a woman's pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston University
• Treatments: Folic Acid; Misoprostol; Vitamin B Complex

Criteria

Inclusion Criteria:

• English or Spanish speaking

• Gestational age between 16 weeks 6 days and 20 weeks 6 days gestation by ultrasound dating on the day of enrollment

• Ultrasound used for dating purposes must be within the last two weeks.

• Women 18-50 years of age undergoing surgical termination of pregnancy

Exclusion Criteria:

• Spontaneous fetal demise

• Ruptured membranes or intrauterine infection

• Fibroids that significantly distort the uterine shape

• Uterine abnormality such as unicornuate uterus

• Prior transmural myomectomy

• Severe oligohydramnios

• Morbid obesity with BMI>45

• Inability to place osmotic dilators