Unwanted PregnancyPhase 4PRIMANCT03600857
Medical Termination of II Trimester Pregnancy
A Phase 4 study testing Home administration of misoprostol in people with Unwanted Pregnancy, run by Karolinska Institutet at 4 sites in Sweden.
Trial summary
The objective of this study is to compare two groups of women requiring termination of pregnancy from the gestational age of 85 days. All women will receive Mifepristone during their first visit to the out-patient ward. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Unwanted Pregnancy
- What is being tested?
- Home administration of misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 457 participants
- Where
- 4 sitesSweden
- Study dates
- 10 Dec 2018to 30 Jun 2023
- Phase
- Phase 4
- 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
Who may be able to join
- Women aged >/= 18 years requesting a termination of pregnancy, for social, medical or foetal indications
- gestational age 85 - 153 days (with ultrasonography),
- willing and able to understand and participate after the study has been explained, with good understanding of Swedish or English language,
- general good health,
- single intra-uterine pregnancy,
Who cannot join
- do not wish to participate or unable to communicate in Swedish or English.
- non-viable pregnancy (confirmed by ultrasonography).
- a history or evidence of disorders that represent a contraindication to the use of Mifepristone or Misoprostol (adrenal pathology, steroid dependent cancer, porphyria, known allergy to the medication).
- any pre-existing health conditions for whom the execution of a medical abortion as judged by the investigator could compromise their condition (Examples of health conditions of concern are: severe anaemia, severe asthma, haemorrhagic disorders, treatment with anticoagulants or corticoids, severe cardiac disease or hypertension, severe liver disease, severe kidney disease or severe psychiatric disorders).
- Fetal malformation that may impact time-to-expulsion (such as hydrocephalus, hydrops/edema) or a duplex pregnancy.
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Clinics of Obstetrics and Gynaecology at: The Department of Gynecology and reproductive Medicine at Östra sjukhuset, Sahlgrenska University Hospital,
Gothenburg, 416 85
The Department of Obstetrics and Gynaecology at Danderyd Hospital:
Stockholm, Danderyd, 182 88
WHOcentre, Karolinska University Hospital
Stockholm, Solna, 17176
The Department of Obstetrics/Gynaecology, Stockholm South General Hospital (Södersjukhuset),
Stockholm, 11883
About this study
Official title: Medical Termination of Pregnancy From Day 85 to Day 153 of Gestation: A Randomized Comparison Between Administration of the Initial Dose of Misoprostol at Home or in the Clinic
The objective of this study is to compare two groups of women requiring termination of pregnancy from the gestational age of 85 days. All women will receive Mifepristone during their first visit to the out-patient ward. One group of women will receive Misoprostol to administer the first dose (vaginally) at home and 2 hours later they will be admitted to the in-patient ward. They will be informed to present earlier if they start bleeding or experience pain corresponding to more than normal menstrual cramping.
The other group will receive the first dose of Misoprostol (vaginally) when admitted in the in-patient ward (usually in the morning) according to current practice.
- Conditions
- Unwanted Pregnancy
- Being tested
- Home administration of misoprostol
- Keywords
- medical abortion, mifepristone, misoprostol, home use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home administration of misoprostolOther
First dose of misoprostol administration at home
| Study group | Role | What they receive |
|---|---|---|
| Home administration | Experimental | Home administration of 0.8 mg misoprostol pv Receives: Other: Home administration of misoprostol |
| Hospital administration | No intervention | Hospital administration of 0.8 mg misoprostol pv |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women treated as day care patients
No overnight hospitalization required.
Measured: 9 hours from admission to the out patient clinic
Secondary outcomes (9)
induction-to-abortion interval
time in minutes
Measured: From first dose of misoprostol until the expulsion of the foetus or surgical intervention whichever comes first assessed up to 7 days of induction
Time spent in hospital
Duration of time in hospital in hours
Measured: From admission until discharge up to 2 weeks FU
the success rate of the termination of pregnancy at 24 hours
success will be defined as the expulsion of the foetus
Measured: At 24 hours from first dose of misoprostol
Dose of misoprostol
Total dose
Measured: From the first dose to the last dose until 2 weeks FU
Administration of misoprostol
Number of doses
Measured: From the first dose to the last dose until 2 weeks FU
Surgical intervention
surgical interventions for incomplete or retained placenta (evacuation rates)
Measured: From the administration of mifepristone until 2 weeks FU
ncidence of Treatment-Emergent Adverse Events [Safety and Tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0visit
Measured: From the administration of mifepristone until 2 weeks FU
Acceptability
Acceptability with allocated treatment (evaluated by two pretested questions)
Measured: At follow up two weeks after abortion
Painscores
maximal pain score during the abortion measured on a 10mm visual analogue scale from 1 to 10mm
Measured: From the administration of mifepristone until 2 weeks FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start10 Dec 2018
- Primary completion31 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unwanted PregnancyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, multicentre, RCT
- Masking
- None (open label)
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Gemzell Danielsson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600857
- Sponsor's protocol ID
- WP2018
- Acronym
- PRIMA
- Status last verified
- Oct 2023
- First submitted
- 2 Jun 2018
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Termination of Pregnancy From Day 85 to Day 153 of Gestation: A Randomized Comparison Between Administration of the Initial Dose of Misoprostol at Home or in the Clinic
- ClinicalTrials.gov ID
- NCT03600857
- Acronym / sponsor ID
- PRIMA / WP2018
- Conditions
- Unwanted Pregnancy
- Keywords
- medical abortion, mifepristone, misoprostol, home use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 Jul 2018 (actual)
- 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.
The objective of this study is to compare two groups of women requiring termination of pregnancy from the gestational age of 85 days. All women will receive Mifepristone during their first visit to the out-patient ward. One group of women will receive Misoprostol to administer the first dose (vaginally) at home and 2 hours later they will be admitted to the in-patient ward. They will be informed to present earlier if they start bleeding or experience pain corresponding to more than normal menstrual cramping.
The other group will receive the first dose of Misoprostol (vaginally) when admitted in the in-patient ward (usually in the morning) according to current practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, multicentre, RCT
| Arm | Type | Receives |
|---|---|---|
| Home administration | Experimental | Other: Home administration of misoprostolHome administration of 0.8 mg misoprostol pv |
| Hospital administration | No intervention | –Hospital administration of 0.8 mg misoprostol pv |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged >/= 18 years requesting a termination of pregnancy, for social, medical or foetal indications
- gestational age 85 - 153 days (with ultrasonography),
- willing and able to understand and participate after the study has been explained, with good understanding of Swedish or English language,
- general good health,
- single intra-uterine pregnancy,
Key exclusion criteria (5 listed)
- do not wish to participate or unable to communicate in Swedish or English.
- non-viable pregnancy (confirmed by ultrasonography).
- a history or evidence of disorders that represent a contraindication to the use of Mifepristone or Misoprostol (adrenal pathology, steroid dependent cancer, porphyria, known allergy to the medication).
- any pre-existing health conditions for whom the execution of a medical abortion as judged by the investigator could compromise their condition (Examples of health conditions of concern are: severe anaemia, severe asthma, haemorrhagic disorders, treatment with anticoagulants or corticoids, severe cardiac disease or hypertension, severe liver disease, severe kidney disease or severe psychiatric disorders).
- Fetal malformation that may impact time-to-expulsion (such as hydrocephalus, hydrops/edema) or a duplex pregnancy.
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 |
|---|---|---|
| Home administration of misoprostolFirst dose of misoprostol administration at home | Other | Home administration |
Primary outcome
Number of women treated as day care patients
Time frame: 9 hours from admission to the out patient clinic
No overnight hospitalization required.
9 secondary outcomes
induction-to-abortion interval
Time frame: From first dose of misoprostol until the expulsion of the foetus or surgical intervention whichever comes first assessed up to 7 days of induction
Time spent in hospital
Time frame: From admission until discharge up to 2 weeks FU
the success rate of the termination of pregnancy at 24 hours
Time frame: At 24 hours from first dose of misoprostol
Dose of misoprostol
Time frame: From the first dose to the last dose until 2 weeks FU
Administration of misoprostol
Time frame: From the first dose to the last dose until 2 weeks FU
Surgical intervention
Time frame: From the administration of mifepristone until 2 weeks FU
ncidence of Treatment-Emergent Adverse Events [Safety and Tolerability
Time frame: From the administration of mifepristone until 2 weeks FU
Acceptability
Time frame: At follow up two weeks after abortion
Painscores
Time frame: From the administration of mifepristone until 2 weeks FU
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 3 Oct 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Home administration of misoprostol in people with Unwanted Pregnancy, run by Karolinska Institutet at 4 sites 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 5 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 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 women treated as day care patients (time frame: 9 hours from admission to the out patient clinic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2023.