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Completed

NCT Number: NCT03600857

Medical Termination of II Trimester Pregnancy

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.

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Key information

Conditions

Unwanted Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The Department of Obstetrics and Gynaecology at Danderyd Hospital:, Stockholm, Danderyd, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home administration of misoprostol

Other

First dose of misoprostol administration at home

Primary outcomes

  1. Number of women treated as day care patients

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

    No overnight hospitalization required.

Secondary outcomes

  1. induction-to-abortion interval

    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 in minutes

  2. Time spent in hospital

    Time frame: From admission until discharge up to 2 weeks FU

    Duration of time in hospital in hours

  3. the success rate of the termination of pregnancy at 24 hours

    Time frame: At 24 hours from first dose of misoprostol

    success will be defined as the expulsion of the foetus

  4. Dose of misoprostol

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

    Total dose

  5. Administration of misoprostol

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

    Number of doses

  6. Surgical intervention

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

    surgical interventions for incomplete or retained placenta (evacuation rates)

  7. ncidence of Treatment-Emergent Adverse Events [Safety and Tolerability

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

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0visit

  8. Acceptability

    Time frame: At follow up two weeks after abortion

    Acceptability with allocated treatment (evaluated by two pretested questions)

  9. Painscores

    Time frame: 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

Other outcomes

  1. Premature admissions

    Time frame: Time form Intake of mifepristone until 54 hours

    number of women who need to be admitted to the hospital earlier prior to planned admission and for which reasons will be registered.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study 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

Acronym: PRIMA

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Jul 26, 2018
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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