Medical Termination of II Trimester Pregnancy (PRIMA)

Karolinska Institute

Status and phase

Completed

Phase 4

Conditions

Unwanted Pregnancy

Treatments

Other: Home administration of misoprostol

Study type

Interventional

Funder types

Other

Identifiers

NCT03600857

WP2018

Details and patient eligibility

About

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.

Enrollment

457 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.