Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06078501
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-22
First Post:
2023-10-05
Brief Title:
MisOpRostol Effect on Second Trimester Abortion Blood Loss
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Misoprostol Effect on Second Trimester Abortion Blood Loss
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
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:
MORESTABL
Brief Summary:
Although serious complications from second trimester abortion are rare hemorrhage is the most common cause of procedural abortion related morbidity and mortality Misoprostol is a prostaglandin E1 analogue that is used by 75 of clinicians prior to procedural abortion for the purpose of cervical preparation Misoprostol is also known to decrease blood loss in first trimester abortion and is used to treat postpartum hemorrhage however the effect of preprocedural misoprostol on procedural blood loss is not well described
We will conduct a double blinded placebo-controlled gestational age stratified superiority trial of those undergoing procedural abortion between 18 and 23 weeks gestation at Stanford Health care Participants will be randomized to either 400mcg buccal misoprostol or placebo on the day of the procedure A quantified blood loss QBL will be measured during the procedure and participants will complete a survey to assess symptoms Our primary outcome is quantified blood loss Secondary outcomes include clinical interventions to manage excess bleeding total procedure time provider reported experience patient reported experience
We will conduct a double blinded placebo-controlled gestational age stratified superiority trial of those undergoing procedural abortion between 18 and 23 weeks gestation at Stanford Health care Participants will be randomized to either 400mcg buccal misoprostol or placebo on the day of the procedure A quantified blood loss QBL will be measured during the procedure and participants will complete a survey to assess symptoms Our primary outcome is quantified blood loss Secondary outcomes include clinical interventions to manage excess bleeding total procedure time provider reported experience patient reported experience
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None