Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310921
Status:
COMPLETED
Last Update Posted:
2007-04-11
First Post:
2006-04-03
Brief Title:
A Randomized Study of Cervical Priming With Misoprostol Prior to Elective First Trimester Pregnancy Termination
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
A Randomized Study of Cervical Priming With Misoprostol Prior to Elective First Trimester Pregnancy Termination Effects on Pain Ease of Procedure and Complications
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether misoprostol administered prior to elective first trimester pregnancy has an effect on pain and ease of procedure and complications
Detailed Description:
Previous studies suggest that cervical priming with misoprostol may facilitate vacuum aspiration for first trimester termination by inducing cervical dilation This medication is used routinely at some abortion clinics not at all at others and is used sporadically at most Kaiser facilities The present study is designed to investigate whether the use of misoprostol noticeably improves the clinical experience We will determine whether use of misoprostol compared with placebo during first trimester abortion 1 positively impacts ratings of pain experienced by the patient 2 positively impacts physicians ratings regarding difficulty of the procedure and 3 reduces complications
Misoprostol is effective for cervical priming prior to vacuum aspiration for first trimester pregnancy termination2 Previous studies examined dose34 route of administration oral5 or vaginal67 and time interval to allow maximum dilation while limiting side effects and bleeding prior to procedure8910 There is evidence supporting a specific dose route and time interval10 Previous studies also examined amount of bleeding length of procedure force used to dilate the cervix and cervical dilation in mm10 However it is unknown whether these statistically significant changes translate into clinically relevant changes For example Ngai et al10 report that the blood loss is significantly decreased However the mean blood loss differed at most by 68 ml It is widely accepted that during surgical procedures a difference of 68 ml of blood will not change the patients hematocrit or postoperative clinical course In the same study preoperative baseline cervical dilation was only 17 mm different also found to be statistically significant but there is no evidence that this difference changes the clinical experience for either the physician or the patient All previous studies reviewed were also performed with the patient under general anesthesia so the patients perception of pain was not examined Because the majority of first trimester terminations in the US are done with the patient awake it is important to consider pain
Misoprostol is effective for cervical priming prior to vacuum aspiration for first trimester pregnancy termination2 Previous studies examined dose34 route of administration oral5 or vaginal67 and time interval to allow maximum dilation while limiting side effects and bleeding prior to procedure8910 There is evidence supporting a specific dose route and time interval10 Previous studies also examined amount of bleeding length of procedure force used to dilate the cervix and cervical dilation in mm10 However it is unknown whether these statistically significant changes translate into clinically relevant changes For example Ngai et al10 report that the blood loss is significantly decreased However the mean blood loss differed at most by 68 ml It is widely accepted that during surgical procedures a difference of 68 ml of blood will not change the patients hematocrit or postoperative clinical course In the same study preoperative baseline cervical dilation was only 17 mm different also found to be statistically significant but there is no evidence that this difference changes the clinical experience for either the physician or the patient All previous studies reviewed were also performed with the patient under general anesthesia so the patients perception of pain was not examined Because the majority of first trimester terminations in the US are done with the patient awake it is important to consider pain
Study Oversight
Has Oversight DMC:
None
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?:
None