Clinical trial NCT03600857: Medical Termination of II Trimester Pregnancy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Unwanted Pregnancy
Keywords: medical abortion
mifepristone
misoprostol
home use
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 457
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label, multicentre, RCT
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Number of women treated as day care patients
timeFrame: 9 hours from admission to the out patient clinic
Secondary outcomes:
measure: induction-to-abortion interval
timeFrame: From first dose of misoprostol until the expulsion of the foetus or surgical intervention whichever comes first assessed up to 7 days of induction
measure: Time spent in hospital
timeFrame: From admission until discharge up to 2 weeks FU
measure: the success rate of the termination of pregnancy at 24 hours
timeFrame: At 24 hours from first dose of misoprostol
measure: Dose of misoprostol
timeFrame: From the first dose to the last dose until 2 weeks FU
measure: Administration of misoprostol
timeFrame: From the first dose to the last dose until 2 weeks FU
measure: Surgical intervention
timeFrame: From the administration of mifepristone until 2 weeks FU
measure: ncidence of Treatment-Emergent Adverse Events [Safety and Tolerability
timeFrame: From the administration of mifepristone until 2 weeks FU
measure: Acceptability
timeFrame: At follow up two weeks after abortion
measure: Painscores
timeFrame: From the administration of mifepristone until 2 weeks FU
Other outcomes:
measure: Premature admissions
timeFrame: Time form Intake of mifepristone until 54 hours
Locations:
city: Stockholm
country: Sweden
facility: The Department of Obstetrics and Gynaecology at Danderyd Hospital:
state: Danderyd
city: Stockholm
country: Sweden
facility: WHOcentre, Karolinska University Hospital
state: Solna
city: Gothenburg
country: Sweden
facility: Clinics of Obstetrics and Gynaecology at: The Department of Gynecology and reproductive Medicine at Östra sjukhuset, Sahlgrenska University Hospital,
city: Stockholm
country: Sweden
facility: The Department of Obstetrics/Gynaecology, Stockholm South General Hospital (Södersjukhuset),
Study officials:
References: