Pregnancy ComplicationsNCT02191774
Medical Abortion up to 10 Weeks Gestation at Home
An observational study of Pregnancy Complications and Legally Induced Abortion Without Mention of Complication, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Medical abortion performed in the womens home has shown to be safe and acceptable up to 9 weeks of gestation. Our project is aiming to confirm our hypothesis that it is equally effective, safe and acceptable when the gestation is more advanced, up to 10 weeks of gestation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Complications, Legally Induced Abortion Without Mention of Complication
- What is being tested?
- Medical abortion at home
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 273 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2014to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with an unwanted pregnancy opting for medical abortion
Who may be able to join
- Healthy
- Requesting and eligible for medical abortion
- Confirmed intrauterine pregnancy
- Gestational length no more than 70 days
- Hemoglobin over 100g/l
Who cannot join
- Anemia
- Contraindication to mifepristone (steroid-dependant cancer, porphyria)
- Breast feeding
- Advanced pregnancy (>70 days)
- Known liver disease
- Bleeding disorder
- Arterial hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Medical abortion performed in the womens home has shown to be safe and acceptable up to 9 weeks of gestation. Our project is aiming to confirm our hypothesis that it is equally effective, safe and acceptable when the gestation is more advanced, up to 10 weeks of gestation.
Read the detailed description
The study will include 600 women opting for medical abortion. Women wanting to perform the last part of the abortion in their homes will be invited to participate. 300 women with a pregnancy up to 9 weeks of gestation (63 days) will be compared to 300 women with a gestation length between 64 and 70 days of gestation. The primary endpoints will be number of patients with an incomplete abortion, with a need for surgical or pharmaceutical intervention.
Secondary endpoints include duration of bleeding, acceptance and satisfaction with the method and number of additional visits to the clinic/facility.
The study will be performed in five abortion clinics in Sweden.
- Being tested
- Medical abortion at home
- Keywords
- Medical abortion, Home abortion
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical abortion at homeProcedure or surgery
Medical abortion using Mifepristone at the clinic followed by Cytotec at home
| Study group | Role | What they receive |
|---|---|---|
| Gestational length up to 63 days | Medical abortion at home using 200 mg of Mifepristone orally at the clinic followed by 0.8 mg Cytotec vaginally at home 48 hours later Receives: Procedure: Medical abortion at home | |
| Gestational length 64-70 days | Medical abortion at home using 200 mg of Mifepristone orally at the clinic followed by 0.8 mg Cytotec vaginally at home 48 hours later Receives: Procedure: Medical abortion at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of incomplete abortions
Need for surgical or pharmaceutical intervention
Measured: 4 weeks after treatment
Secondary outcomes (3)
Duration of bleeding
Measured by diary and questionnaires
Measured: 4 weeks after treatment
Acceptance and satisfaction of treatment
Questionnaires
Measured: 4 weeks after treatment
Number of additional visits to the clinic
Measured: 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lena Marions, Karolinska Institutet
- Investigators
- Lena Marions, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191774
- Sponsor's protocol ID
- Marions 2014 1.2
- Other IDs
- 2013-004749-18
- Status last verified
- Jun 2022
- First submitted
- 14 Jul 2014
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Podolskyi V, Gemzell-Danielsson K, Maltzman LL, Marions L. Effectiveness and acceptability of home use of misoprostol for medical abortion up to 10 weeks of pregnancy. Acta Obstet Gynecol Scand. 2023 May;102(5):541-548. doi: 10.1111/aogs.14549. Epub 2023 Mar 18.
PubMed 36933004
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Abortion up to 10 Weeks Gestation at Home
- ClinicalTrials.gov ID
- NCT02191774
- Acronym / sponsor ID
- Marions 2014 1.2
- Keywords
- Medical abortion, Home abortion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Medical abortion performed in the womens home has shown to be safe and acceptable up to 9 weeks of gestation. Our project is aiming to confirm our hypothesis that it is equally effective, safe and acceptable when the gestation is more advanced, up to 10 weeks of gestation.
Detailed description
The study will include 600 women opting for medical abortion. Women wanting to perform the last part of the abortion in their homes will be invited to participate. 300 women with a pregnancy up to 9 weeks of gestation (63 days) will be compared to 300 women with a gestation length between 64 and 70 days of gestation. The primary endpoints will be number of patients with an incomplete abortion, with a need for surgical or pharmaceutical intervention.
Secondary endpoints include duration of bleeding, acceptance and satisfaction with the method and number of additional visits to the clinic/facility.
The study will be performed in five abortion clinics in Sweden.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gestational length up to 63 days | – | Procedure: Medical abortion at homeMedical abortion at home using 200 mg of Mifepristone orally at the clinic followed by 0.8 mg Cytotec vaginally at home 48 hours later |
| Gestational length 64-70 days | – | Procedure: Medical abortion at homeMedical abortion at home using 200 mg of Mifepristone orally at the clinic followed by 0.8 mg Cytotec vaginally at home 48 hours later |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with an unwanted pregnancy opting for medical abortion
Key inclusion criteria (5 listed)
- Healthy
- Requesting and eligible for medical abortion
- Confirmed intrauterine pregnancy
- Gestational length no more than 70 days
- Hemoglobin over 100g/l
Key exclusion criteria (7 listed)
- Anemia
- Contraindication to mifepristone (steroid-dependant cancer, porphyria)
- Breast feeding
- Advanced pregnancy (>70 days)
- Known liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical abortion at homeMedical abortion using Mifepristone at the clinic followed by Cytotec at home | Procedure or surgery | Gestational length 64-70 days, Gestational length up to 63 days |
Primary outcome
Number of incomplete abortions
Time frame: 4 weeks after treatment
Need for surgical or pharmaceutical intervention
3 secondary outcomes
Duration of bleeding
Time frame: 4 weeks after treatment
Acceptance and satisfaction of treatment
Time frame: 4 weeks after treatment
Number of additional visits to the clinic
Time frame: 4 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Derived from this study: PubMed 36933004Podolskyi V, Gemzell-Danielsson K, Maltzman LL, Marions L. Effectiveness and acceptability of home use of misoprostol for medical abortion up to 10 weeks of pregnancy. Acta Obstet Gynecol Scand. 2023 May;102(5):541-548. doi: 10.1111/aogs.14549. Epub 2023 Mar 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena Marions, MD PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complications and Legally Induced Abortion Without Mention of Complication, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of incomplete abortions (time frame: 4 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02191774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.