Comparing Buccal and Vaginal Misoprostol in Management of Early Pregnancy Loss

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

First trimester miscarriages are common. When the failed pregnancy does not pass spontaneously on its own, it is called a missed abortion. There are several ways in which missed abortions are managed, one of which involves administering a medication called misoprostol which causes uterine contractions inducing expulsion of the failed pregnancy. Misoprostol can be administered in multiple ways but has been traditionally inserted vaginally when used for management of missed abortions. Some studies have shown that some women are not comfortable with vaginal insertion of misoprostol and prefer oral administration. Buccal misoprostol is a way of administering misoprostol by having the patients insert the tablets of misoprostol between their gum and cheek, letting it dissolve for 30 minutes, then swallowing the remaining remnants. Buccal misoprostol is used safely in medical abortion. In fact a study by Fjerstad et al (2009), found a decrease in infection rate for medical abortion when misoprostol administration was switched from vaginal to buccal route combined with routine administration of doxycycline. The efficacy of using buccal misoprostol to treat missed abortions has not been studied previously to the investigators' knowledge. In this pilot study, investigators aim to test the hypotheses that buccal misoprostol is equally effective as vaginal misoprostol in the medical management of early pregnancy loss. As secondary outcomes, investigators suspect that buccal misoprostol may be associated with higher rates of gastrointestinal side effect but that patient satisfaction will remain equally as high for buccal misoprostol as for vaginal misoprostol.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Diego
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

• Women ages 18-50 who are English or Spanish speaking

• First trimester pregnancy (less than 13 weeks and 0 days)

• Desires medical management of an early pregnancy loss with misoprostol

• Diagnosed with an early pregnancy failure by UCSD Radiology or diagnosed early pregnancy failure defined by any of the following criteria (Bourne 2013):

• Crown-rump length > 7mm with no cardiac activity

• Mean gestational sac diameter of > 25 mm and no embryo

• Absence of an embryo with heartbeat > 2 weeks after a scan showing a gestational sac without a yolk sac

• Absence of embryo with heartbeat > 11 days after a scan showing a gestational sac with a yolk sac

Exclusion Criteria:

• Evidence of infection, acute hemorrhage, or hemodynamic instability

• Hemoglobin less than 9.5 including use of point of care Hgb testing

• Known allergy to misoprostol

• Underwent surgical or medical abortion during current pregnancy

• Currently breastfeeding

• Currently has intrauterine device in place

• Suspicion of ectopic or gestational trophoblastic disease

• History of clotting disorder or on anticoagulant therapy (excluding aspirin)

• Unreliable for follow up