Medical Termination of II Trimester Pregnancy

NCT03600857 | Completed Phase 4 DMC

• 1 other identifier: WP2018
• Study Type: interventional
• Target: 457
• Locations: 1 country
• Sites: 4

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

Keywords

medical abortion; mifepristone; misoprostol; home use

Outcome Measures

Primary Outcomes (1)

• Number of women treated as day care patients

  No overnight hospitalization required.

  9 hours from admission to the out patient clinic

Secondary Outcomes (9)

• induction-to-abortion interval

  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

  From admission until discharge up to 2 weeks FU

• the success rate of the termination of pregnancy at 24 hours

  At 24 hours from first dose of misoprostol

• Dose of misoprostol

  From the first dose to the last dose until 2 weeks FU

• Administration of misoprostol

  From the first dose to the last dose until 2 weeks FU

Other Outcomes (1)

• Premature admissions

  Time form Intake of mifepristone until 54 hours

Study Arms (2)

Home administration

EXPERIMENTAL

Home administration of 0.8 mg misoprostol pv

Other: Home administration of misoprostol

Hospital administration

NO INTERVENTION

Hospital administration of 0.8 mg misoprostol pv

Interventions

Home administration of misoprostol OTHER

First dose of misoprostol administration at home

Home administration

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (4)

The Department of Obstetrics and Gynaecology at Danderyd Hospital:

Stockholm, Danderyd, 182 88, Sweden

Location

WHOcentre, Karolinska University Hospital

Stockholm, Solna, 17176, Sweden

Location

Clinics of Obstetrics and Gynaecology at: The Department of Gynecology and reproductive Medicine at Östra sjukhuset, Sahlgrenska University Hospital,

Gothenburg, 416 85, Sweden

Location

The Department of Obstetrics/Gynaecology, Stockholm South General Hospital (Södersjukhuset),

Stockholm, 11883, Sweden

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Överläkare

Model Details: Open label, multicentre, RCT

Study Record Dates

• First Submitted: June 2, 2018
• First Posted: July 26, 2018
• Study Start: December 10, 2018
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)