Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-27 @ 12:35 AM
Study NCT ID:
NCT03600857
Status:
COMPLETED
Last Update Posted:
2023-10-03
First Post:
2018-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical Termination of II Trimester Pregnancy
Sponsor:
Karolinska Institutet
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIMA
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: