Optimal Treatment of Miscarriage

Region Skane

Status: Completed

Conditions: Abortion, Spontaneous

Treatments: Drug: misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01033903

EudraCT 2007-007661-20

Details and patient eligibility

About

The main objective of the study is to determine if there is a difference in the number of women with a complete miscarriage after 10 days between expectant management versus treatment with 800 micrograms of misoprostol intravaginally in women with an an incomplete miscarriage before 14 weeks and a gestational sac retained in the uterus.

Enrollment: 190 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• nonviable intrauterine pregnancy with retained gestational sac in the uterus
• the embryo if visible 5 to 35 mm without a heart beat
• vaginal bleeding
• circulatory stable
• hemoglobin at least 80 g/L

Exclusion criteria

• contraindications against misoprostol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

Misoprostol 800 micrograms intravaginally

Experimental group

Treatment:

Drug: misoprostol

expectant managment

No Intervention group