A Comparison of Sublingual and Buccal Misoprostol Regimens After Mifepristone for Mid-trimester Abortion

Gynuity Health Projects

Status and phase: Unknown; Phase 4

Conditions: Legally Induced Abortion Without Mention of Complication

Treatments: Drug: Sublingual misoprostol; Drug: Buccal misoprostol; Drug: Mifepristone

Study type: Interventional

Funder types: Other

Identifiers

NCT02708446

1013

Details and patient eligibility

About

The primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to determine if sublingual route confers an advantage with respect to efficacy and median time to complete abortion.

Full description

Eligible women 13-21 weeks gestation who give informed consent will be randomized to receive buccal or sublingual misoprostol. Participants will take 200mg mifepristone and return to the hospital 24 hours later to begin induction with misoprostol. 400mcg misoprostol will be given every 3 hours until the expulsion of the fetus and placenta.

Enrollment: 320 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Meet criteria to obtain abortion
• Present with closed cervical os and no vaginal bleeding
• Live fetus at time of presentation for service
• Have no contraindications to study procedures, according to provider
• Be able to consent to procedure, either by reading consent document or by having consent document read to her
• Be willing to follow study procedures

Exclusion criteria

• Known previous transmural uterine incision
• Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
• Any contraindications to vaginal delivery
• Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

320 participants in 2 patient groups

Sublingual misoprostol

Active Comparator group

Description:

200mg mifepristone + 400mcg sublingual misoprostol q3h

Treatment:

Drug: Mifepristone

Drug: Sublingual misoprostol

Buccal misoprostol

Active Comparator group

Description:

200mg mifepristone + 400mcg buccal misoprostol q3h

Treatment:

Drug: Mifepristone

Drug: Buccal misoprostol