Medical Termination of II Trimester Pregnancy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Unwanted Pregnancy

Intervention / Treatment
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* Other: Home administration of misoprostol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open label, multicentre, RCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home administration<br>Home administration of 0.8 mg misoprostol pv | Other: Home administration of misoprostol<br>* First dose of misoprostol administration at home<br>|
| No Intervention: Hospital administration<br>Hospital administration of 0.8 mg misoprostol pv | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical abortion, mifepristone, misoprostol, home use