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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home administration | Experimental | Home administration of 0.8 mg misoprostol pv |
|
| Hospital administration | No Intervention | Hospital administration of 0.8 mg misoprostol pv |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home administration of misoprostol | Other | First dose of misoprostol administration at home |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of women treated as day care patients | No overnight hospitalization required. | 9 hours from admission to the out patient clinic |
| Measure | Description | Time Frame |
|---|---|---|
| induction-to-abortion interval | time in minutes | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Premature admissions | number of women who need to be admitted to the hospital earlier prior to planned admission and for which reasons will be registered. | Time form Intake of mifepristone until 54 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Department of Obstetrics and Gynaecology at Danderyd Hospital: | Stockholm | Danderyd | 182 88 | Sweden | ||
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Open label, multicentre, RCT
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Duration of time in hospital in hours
| 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 | At 24 hours from first dose of misoprostol |
| Dose of misoprostol | Total dose | From the first dose to the last dose until 2 weeks FU |
| Administration of misoprostol | Number of doses | From the first dose to the last dose until 2 weeks FU |
| Surgical intervention | surgical interventions for incomplete or retained placenta (evacuation rates) | 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 | From the administration of mifepristone until 2 weeks FU |
| Acceptability | Acceptability with allocated treatment (evaluated by two pretested questions) | 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 | From the administration of mifepristone until 2 weeks FU |
| WHOcentre, Karolinska University Hospital |
| Stockholm |
| Solna |
| 17176 |
| Sweden |
| Clinics of Obstetrics and Gynaecology at: The Department of Gynecology and reproductive Medicine at Östra sjukhuset, Sahlgrenska University Hospital, | Gothenburg | 416 85 | Sweden |
| The Department of Obstetrics/Gynaecology, Stockholm South General Hospital (Södersjukhuset), | Stockholm | 11883 | Sweden |