Optimal Treatment of Miscarriage

Abortion, Spontaneous Clinical Trial

Official title:

Which is the Optimal Treatment for Miscarriage With a Gestational ac in the Uterus and Which Factors Can Predict if the Treatment Will be Successful?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033903
• Other study ID #: EudraCT 2007-007661-20
• Status: Completed
• Phase: N/A
• Start date: October 1, 2008
• Est. completion date: March 1, 2018

Study information

• Verified date: October 2018
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: March 1, 2018
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Spontaneous

Intervention

Drug:
• misoprostol
800 micrograms intravaginally ONCE

Locations

Country	Name	City	State
Sweden	Region Skane, Kvinnokliniken, University Hopsital MAS	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete miscarriage		10 days
Secondary	complete miscarriage		17 days, 24 days, 31 days