Medical Termination of II Trimester Pregnancy

Karolinska Institutet457 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

457

Conditions

Unwanted Pregnancy

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

The Department of Obstetrics and Gynaecology at Danderyd Hospital:

Stockholm, Danderyd, Sweden

WHOcentre, Karolinska University Hospital

Stockholm, Solna, Sweden

Clinics of Obstetrics and Gynaecology at: The Department of Gynecology and reproductive Medicine at Östra sjukhuset, Sahlgrenska University Hospital,

Gothenburg, Sweden

The Department of Obstetrics/Gynaecology, Stockholm South General Hospital (Södersjukhuset),

Stockholm, Sweden

Outcomes

Primary Outcomes

Number of women treated as day care patients

No overnight hospitalization required.

Time frame: 9 hours from admission to the out patient clinic

Secondary Outcomes

induction-to-abortion interval

time in minutes

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

Duration of time in hospital in hours

Time frame: 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

Time frame: At 24 hours from first dose of misoprostol

Dose of misoprostol

Total dose

Time frame: From the first dose to the last dose until 2 weeks FU

Administration of misoprostol

Number of doses

Time frame: From the first dose to the last dose until 2 weeks FU

Surgical intervention

surgical interventions for incomplete or retained placenta (evacuation rates)

Time frame: 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

Time frame: From the administration of mifepristone until 2 weeks FU

Acceptability

Acceptability with allocated treatment (evaluated by two pretested questions)

Time frame: 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

Time frame: From the administration of mifepristone until 2 weeks FU