Which is the optimal treatment for miscarriage with a gestational sac in the uterus and which factors can predict if the treatment will be successful?

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007661-20-SE

Enrollment

240

Registered

2008-02-28

Start date

2008-04-21

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Miscarriage before 14 gestational weeks with a gestational sac in the uterus identified at ultrasound examiantion MedDRA version: 9.1 Level: LLT Classification code 10027650 Term: Miscarriage of pregnancy

Interventions

Trade Name: cytotec Product Name: cytotec (misoprostol) Pharmaceutical Form: Tablet INN or Proposed INN: misoprostol Current Sponsor code: misoprostol

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -at least 18 years of age -able to understand the information -incomplete miscarriage before 14 weeks, bleeding, closed cervix, gestational sac retained in the uterus (empty with size 16 mm or more or dead embryo 5 - 33 mm, or arrest in development of the pregnancy during at least 7 days of observation) -circulatory stable -Hemoglobin level at least 80g/L -no contraindications against use of misoprostol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: (exclusion criteria = Not eligible) -Intrauterine pregnancy of uncertain viability -non-viable pregnancy WITHOUT bleeding -profuse bleeding requiring immediate surgical evacuation of the uterus -contraindications against misoprostol Exclusions Lost to follow-up Severe hitherto unknown side effects of misoprostol

Design outcomes

Primary

Measure	Time frame
Main Objective: Main objective: to determine if there is a difference in the number of women with a complete miscarriage (contents in uterine cavity measuring < 16 mm in anterior-posterior diameter at transvaginal ultrasound examination and no or minimal bleeding) after 10 days between expectant management and treatment with 800 micrograms of misoprostol intravaginally in women with an incomplete miscarriage before 14 weeks and a gestational sac retained in the uterus;Secondary Objective: To determine if there is a difference between the two treatments in number of women with a complete miscarriage after 17, 24 and 31 days number and type of short time complications (infection, anemia) number of women who undergo surgical evacuation of the uterine cavity use of resources (medical consultations, telephone contacts, sick leave, hospitalisation) anxiety level, depression level and grief of the patients patient satisfaction number of women who are pregnant again within 14 months of their miscarriage being complete (calculated only for women with active desire of pregnancy) To determine which factors can predict the success (complete miscarriage at 10 days) of the two treatments ;Primary end point(s): Complete miscarriage, defined as contents in uterine cavity measuring < 16 mm in anteroposterior diameter at transvaginal ultrasound examiantion and no or minimal bleeding, after 10 days	—

Measure

Time frame

Main Objective: Main objective: to determine if there is a difference in the number of women with a complete miscarriage (contents in uterine cavity measuring < 16 mm in anterior-posterior diameter at transvaginal ultrasound examination and no or minimal bleeding) after 10 days between expectant management and treatment with 800 micrograms of misoprostol intravaginally in women with an incomplete miscarriage before 14 weeks and a gestational sac retained in the uterus;Secondary Objective: To determine if there is a difference between the two treatments in number of women with a complete miscarriage after 17, 24 and 31 days number and type of short time complications (infection, anemia) number of women who undergo surgical evacuation of the uterine cavity use of resources (medical consultations, telephone contacts, sick leave, hospitalisation) anxiety level, depression level and grief of the patients patient satisfaction number of women who are pregnant again within 14 months of their miscarriage being complete (calculated only for women with active desire of pregnancy) To determine which factors can predict the success (complete miscarriage at 10 days) of the two treatments ;Primary end point(s): Complete miscarriage, defined as contents in uterine cavity measuring < 16 mm in anteroposterior diameter at transvaginal ultrasound examiantion and no or minimal bleeding, after 10 days

—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026