Medical Termination of II Trimester Pregnancy (PRIMA)

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

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 Overview

• Status: Completed
• Conditions: Unwanted Pregnancy
• Intervention / Treatment: Other: Home administration of misoprostol

• Study Type: Interventional
• Enrollment (Actual): 457
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 416 85
    • Clinics of Obstetrics and Gynaecology at: The Department of Gynecology and reproductive Medicine at Östra sjukhuset, Sahlgrenska University Hospital,
  • Stockholm, Sweden, 11883
    • The Department of Obstetrics/Gynaecology, Stockholm South General Hospital (Södersjukhuset),
  • Danderyd
    • Stockholm, Danderyd, Sweden, 182 88
      • The Department of Obstetrics and Gynaecology at Danderyd Hospital:
  • Solna
    • Stockholm, Solna, Sweden, 17176
      • WHOcentre, Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home administration; Home administration of 0.8 mg misoprostol pv	Other: Home administration of misoprostol; First dose of misoprostol administration at home
No Intervention: Hospital administration; Hospital administration of 0.8 mg misoprostol pv

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Premature admissions	number of women who need to be admitted to the hospital earlier prior to planned admission and for which reasons will be registered.	Time form Intake of mifepristone until 54 hours

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: June 2, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: medical abortion; mifepristone; misoprostol; home use
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: WP2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No