Medical Termination of II Trimester Pregnancy

Phase 4

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Home administration	Home administration of misoprostol	Home administration of 0.8 mg misoprostol pv

Primary Outcome Measures

Name	Time	Method
Number of women treated as day care patients	9 hours from admission to the out patient clinic	No overnight hospitalization required.

Secondary Outcome Measures

Name	Time	Method
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
Surgical intervention	From the administration of mifepristone until 2 weeks FU	surgical interventions for incomplete or retained placenta (evacuation rates)
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
Time spent in hospital	From admission until discharge up to 2 weeks FU	Duration of time in hospital in hours
Administration of misoprostol	From the first dose to the last dose until 2 weeks FU	Number of doses
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
Dose of misoprostol	From the first dose to the last dose until 2 weeks FU	Total dose
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
Acceptability	At follow up two weeks after abortion	Acceptability with allocated treatment (evaluated by two pretested questions)

Locations (4): The Department of Obstetrics/Gynaecology, Stockholm South General Hospital (Södersjukhuset),
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Stockholm, Sweden
The Department of Obstetrics and Gynaecology at Danderyd Hospital:
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Stockholm, Danderyd, Sweden
WHOcentre, Karolinska University Hospital
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Stockholm, Solna, Sweden
Clinics of Obstetrics and Gynaecology at: The Department of Gynecology and reproductive Medicine at Östra sjukhuset, Sahlgrenska University Hospital,
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Gothenburg, Sweden