Medical Termination of II Trimester Pregnancy

Unwanted Pregnancy Clinical Trial

— PRIMA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03600857
• Other study ID #: WP2018
• Status: Completed
• Phase: Phase 4
• Start date: December 10, 2018
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 457
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Unwanted Pregnancy

Intervention

Other:
• Home administration of misoprostol
First dose of misoprostol administration at home

Locations

Country	Name	City	State
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 and Gynaecology at Danderyd Hospital:	Stockholm	Danderyd
Sweden	The Department of Obstetrics/Gynaecology, Stockholm South General Hospital (Södersjukhuset),	Stockholm
Sweden	WHOcentre, Karolinska University Hospital	Stockholm	Solna

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Number of women treated as day care patients	No overnight hospitalization required.	9 hours from admission to the out patient clinic
Secondary	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
Secondary	Time spent in hospital	Duration of time in hospital in hours	From admission until discharge up to 2 weeks FU
Secondary	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
Secondary	Dose of misoprostol	Total dose	From the first dose to the last dose until 2 weeks FU
Secondary	Administration of misoprostol	Number of doses	From the first dose to the last dose until 2 weeks FU
Secondary	Surgical intervention	surgical interventions for incomplete or retained placenta (evacuation rates)	From the administration of mifepristone until 2 weeks FU
Secondary	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
Secondary	Acceptability	Acceptability with allocated treatment (evaluated by two pretested questions)	At follow up two weeks after abortion
Secondary	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