Repeated doses of misoprostol for medical treatment of intact miscarriage

Repeated doses of misoprostol for medical treatment of missed abortion

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001505-26-SE

Enrollment

140

Registered

2011-08-12

Start date

2011-11-02

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

Intact miscarriage which has not been expelled from the body (missed abortion)

Interventions

Trade Name: Cytotec Product Name: Cytotec Pharmaceutical Form: Tablet CAS Number: 59122-46-2 Other descriptive name: MISOPROSTOL Concentration unit: mg milligram(s) Concentration type: equal Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with missed abortion with visible fetal structures without progress in time or stable or sinking levels of s-hcg, over 18 years of age and in good general health, opting for medical treatment and willing to participate in the study will be included. 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 140 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with an empty gestational sac, more than a sparse ongoing bleeding or cervical dilation as signs of ongoing miscarriage, mental instability after the diagnosis or any contraindication to medical treatment such as bleeding disorder or contraindication to any medication given during medical treatment will be excluded

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary obejctive of this study is to evaluate the efficacy of repeated doses of oral misoprostol after initial vaginal misoprostol for the medical treatment of missed abortion. The hypothesis is that treatment with repeated doses of misoprostol increases the proportion of patients who abort during the same day the treatment is administered. ;Secondary Objective: The secondary objectives are evaluation of efficacy, bleeding time and side effects at follow up after one, two, three and five weeks and to evaluate the acceptance of this treatment.;Primary end point(s): Expulsion of miscarriage on the same day as treament;Timepoint(s) of evaluation of this end point: same day as treatment	—

Measure

Time frame

Main Objective: The primary obejctive of this study is to evaluate the efficacy of repeated doses of oral misoprostol after initial vaginal misoprostol for the medical treatment of missed abortion. The hypothesis is that treatment with repeated doses of misoprostol increases the proportion of patients who abort during the same day the treatment is administered. ;Secondary Objective: The secondary objectives are evaluation of efficacy, bleeding time and side effects at follow up after one, two, three and five weeks and to evaluate the acceptance of this treatment.;Primary end point(s): Expulsion of miscarriage on the same day as treament;Timepoint(s) of evaluation of this end point: same day as treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Length of bleeding, frequency of side effects, number of emergency visits;Timepoint(s) of evaluation of this end point: Follow up at 1,2,3 and 5 weeks	—

Countries

Sweden

Contacts

Public ContactKristina Gemzell Danielsson

Karolinska Institutet

4685177 00 00

Outcome results

None listed

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