Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT01678703
Status:
COMPLETED
Last Update Posted:
2012-09-05
First Post:
2012-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion
Sponsor:
Wolfson Medical Center
Organization:
Study Overview
Official Title:
Randomized Controlled Study: Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion
Status:
COMPLETED
Status Verified Date:
2012-07
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:
None
Brief Summary:
This study compares the effectiveness of cervical preparation before second trimester abortion using laminaria versus vaginal Misoprostol.
The investigators hypothesize that medical preparation of the cervix with vaginal Misoprostol is superior to mechanical preparation using laminaria.
The investigators believe that medical preparation makes the procedure easier to perform, equally safe, without addition of pain or discomfort.
The investigators hypothesize that medical preparation of the cervix with vaginal Misoprostol is superior to mechanical preparation using laminaria.
The investigators believe that medical preparation makes the procedure easier to perform, equally safe, without addition of pain or discomfort.
Detailed Description:
This is a prospective randomized study.
The aim of the study is to compare preparation of the cervix before surgical abortion with laminaria and misoprostol.
Primary outcome measures will include:
Initial cervical opening and the need for further dilatation at the procedure Procedure duration
Difficulty score performing the abortion
Complications during and after the procedure
Assessment of pain, using VAS scale, and the need for analgesia before and after the procedure
The aim of the study is to compare preparation of the cervix before surgical abortion with laminaria and misoprostol.
Primary outcome measures will include:
Initial cervical opening and the need for further dilatation at the procedure Procedure duration
Difficulty score performing the abortion
Complications during and after the procedure
Assessment of pain, using VAS scale, and the need for analgesia before and after the procedure
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: