PRIMA: Medical Termination of II Trimester Pregnancy
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Home administration Home administration of 0.8 mg misoprostol pv |
Other: Home administration of misoprostol
First dose of misoprostol administration at home
|
| No Intervention: Hospital administration Hospital administration of 0.8 mg misoprostol pv |
Outcome Measures
Primary Outcome Measures
- Number of women treated as day care patients [9 hours from admission to the out patient clinic]
No overnight hospitalization required.
Secondary Outcome Measures
- induction-to-abortion interval [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 in minutes
- Time spent in hospital [From admission until discharge up to 2 weeks FU]
Duration of time in hospital in hours
- the success rate of the termination of pregnancy at 24 hours [At 24 hours from first dose of misoprostol]
success will be defined as the expulsion of the foetus
- Dose of misoprostol [From the first dose to the last dose until 2 weeks FU]
Total dose
- Administration of misoprostol [From the first dose to the last dose until 2 weeks FU]
Number of doses
- Surgical intervention [From the administration of mifepristone until 2 weeks FU]
surgical interventions for incomplete or retained placenta (evacuation rates)
- ncidence of Treatment-Emergent Adverse Events [Safety and Tolerability [From the administration of mifepristone until 2 weeks FU]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0visit
- Acceptability [At follow up two weeks after abortion]
Acceptability with allocated treatment (evaluated by two pretested questions)
- Painscores [From the administration of mifepristone until 2 weeks FU]
maximal pain score during the abortion measured on a 10mm visual analogue scale from 1 to 10mm
Other Outcome Measures
- Premature admissions [Time form Intake of mifepristone until 54 hours]
number of women who need to be admitted to the hospital earlier prior to planned admission and for which reasons will be registered.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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,
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Department of Obstetrics and Gynaecology at Danderyd Hospital: | Stockholm | Danderyd | Sweden | 182 88 |
| 2 | WHOcentre, Karolinska University Hospital | Stockholm | Solna | Sweden | 17176 |
| 3 | Clinics of Obstetrics and Gynaecology at: The Department of Gynecology and reproductive Medicine at Östra sjukhuset, Sahlgrenska University Hospital, | Gothenburg | Sweden | 416 85 | |
| 4 | The Department of Obstetrics/Gynaecology, Stockholm South General Hospital (Södersjukhuset), | Stockholm | Sweden | 11883 |
Sponsors and Collaborators
- Karolinska Institutet
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WP2018