Medical abortion in very early pregnancy

Efficacy of Very Early Medical Abortion – a randomized controlled non-inferiority trial - VEMA – Very Early Medical Abortion Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003675-35-SE

Enrollment

1500

Registered

2018-09-24

Start date

2018-11-01

Completion date

Unknown

Last updated

2023-12-12

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

Conditions

Unwanted pregnancy

Interventions

Trade Name: Cytotec Product Name: Cytotec Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Women 18 years of age or above eligible for medical abortion 2. No signs of pathological pregnancy 3. No confirmed IUP 4. Willing and able to participate after the study has been explained 5. Signed informed consent 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 1500 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Allergy towards mifepristone or misoprostol 2. A medical condition or disease that requires special treatment, care or precaution (e.g. corticosteroid or anticoagulant therapy) in conjunction with abortion

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate is if the efficacy of VEMA is non-inferior within a non-inferiority margin of 3 percent to delayed abortion treatment initiated when an intrauterine pregnancy (IUP) can be confirmed on ultrasound? ;Secondary Objective: 1.Safety; Proportions of adverse events (AE), and serious AE (SAE)) includes bleeding, genital infections and complications to surgical interventions will be compared between the treatment groups. 2.Ectopic and other pathologic pregnancies (time point at diagnosis, treatment, numbers, percentage ruptured/unruptured). Defined as “outcome of special interest”. 3.Any additional medical treatment of incomplete abortion or ongoing pregnancy, bleeding (days), pain (VAS score), surgical treatment for ongoing pregnancy, incomplete abortion or any other indications, unscheduled contacts and visits, acceptability with the time of the abortion treatment (early/delayed, would recommend to a friend yes/no) and initiation of postabortion contraception (yes/no, type). ;Primary end point(s): Complete abortion without surgical intervention;Timepoint(s) of evaluation of this end point: within 30 days of the abortion treatment	—

Measure

Time frame

Main Objective: To investigate is if the efficacy of VEMA is non-inferior within a non-inferiority margin of 3 percent to delayed abortion treatment initiated when an intrauterine pregnancy (IUP) can be confirmed on ultrasound? ;Secondary Objective: 1.Safety; Proportions of adverse events (AE), and serious AE (SAE)) includes bleeding, genital infections and complications to surgical interventions will be compared between the treatment groups. 2.Ectopic and other pathologic pregnancies (time point at diagnosis, treatment, numbers, percentage ruptured/unruptured). Defined as “outcome of special interest”. 3.Any additional medical treatment of incomplete abortion or ongoing pregnancy, bleeding (days), pain (VAS score), surgical treatment for ongoing pregnancy, incomplete abortion or any other indications, unscheduled contacts and visits, acceptability with the time of the abortion treatment (early/delayed, would recommend to a friend yes/no) and initiation of postabortion contraception (yes/no, type). ;Primary end point(s): Complete abortion without surgical intervention;Timepoint(s) of evaluation of this end point: within 30 days of the abortion treatment

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Safety; Proportions of adverse events (AE), and serious AE (SAE)) includes bleeding, genital infections and complications to surgical interventions will be compared between the treatment groups. 2. Ectopic and other pathologic pregnancies (time point at diagnosis, treatment, numbers, percentage ruptured/unruptured). Defined as “outcome of special interest”. 3. Any additional medical treatment of incomplete abortion or ongoing pregnancy, bleeding (days), pain (VAS score), surgical treatment for ongoing pregnancy, incomplete abortion or any other indications, unscheduled contacts and visits, acceptability with the time of the abortion treatment (early/delayed, would recommend to a friend yes/no) and initiation of postabortion contraception (yes/no, type). ;Timepoint(s) of evaluation of this end point: within 30 days of the abortion treatment	—

Measure

Time frame

Secondary end point(s): 1. Safety; Proportions of adverse events (AE), and serious AE (SAE)) includes bleeding, genital infections and complications to surgical interventions will be compared between the treatment groups. 2. Ectopic and other pathologic pregnancies (time point at diagnosis, treatment, numbers, percentage ruptured/unruptured). Defined as “outcome of special interest”. 3. Any additional medical treatment of incomplete abortion or ongoing pregnancy, bleeding (days), pain (VAS score), surgical treatment for ongoing pregnancy, incomplete abortion or any other indications, unscheduled contacts and visits, acceptability with the time of the abortion treatment (early/delayed, would recommend to a friend yes/no) and initiation of postabortion contraception (yes/no, type). ;Timepoint(s) of evaluation of this end point: within 30 days of the abortion treatment

—

Countries

Austria, Denmark, Finland, Sweden

Contacts

Public ContactKristina Gemzell Danielsson

Karolinska Instituet

kristina.gemzell@ki.se4608517700002128

Outcome results

None listed

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