Medical Termination of II Trimester Pregnancy

NCT ID: NCT03600857

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 457 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-10
• Study Completion Date: 2023-06-30

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.

Conditions

Unwanted Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Home administration

Home administration of 0.8 mg misoprostol pv

Group Type: EXPERIMENTAL

Home administration of misoprostol

Intervention Type: OTHER

First dose of misoprostol administration at home

Hospital administration

Hospital administration of 0.8 mg misoprostol pv

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Home administration of misoprostol

First dose of misoprostol administration at home

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Kristina Gemzell Danielsson

Professor, Överläkare

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Department of Obstetrics and Gynaecology at Danderyd Hospital:

Stockholm, Danderyd, Sweden

WHOcentre, Karolinska University Hospital

Stockholm, Solna, 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/Gynaecology, Stockholm South General Hospital (Södersjukhuset),

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

WP2018

Identifier Type: -

Identifier Source: org_study_id