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OpenTrials
Completed

NCT Number: NCT01033903

Optimal Treatment of Miscarriage

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.

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Key information

Conditions

Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Region Skane, Kvinnokliniken, University Hopsital MAS

Malmö, SE 20502, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

800 micrograms intravaginally ONCE

Primary outcomes

  1. complete miscarriage

    Time frame: 10 days

Secondary outcomes

  1. complete miscarriage

    Time frame: 17 days, 24 days, 31 days

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study 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?

Important dates

Study start
2008
Primary completion
2015
Study completion
2018
First posted
Dec 17, 2009
Registry last updated
Oct 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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