Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-17
Brief Title:
Oxytocin Effectiveness in First Trimester Dilatation and Curettage
Sponsor:
Assuta Ashdod Hospital
Organization:
Assuta Ashdod Hospital
Study Overview
Official Title:
Oxytocin Effectiveness in First Trimester Dilatation and Curettage
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
The aim of this study is to investigate the impact of oxytocin on perioperative blood loss during the DC procedure as well as to assess early and late complications associated with its use
Detailed Description:
Study Design
This study is a prospective randomized placebo-controlled double-blind trial Women undergoing dilation and curettage who meet the eligibility criteria for the study will be divided into two groups They will receive the assigned medication at the beginning of the procedure after cervical dilation but before using suction curettage
Group 1 Participants will receive 100 ml of saline alone Group 2 Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline
The medication bags will be prepared by the Assuta Ashdod University Hospital Pharmacy coded with serial numbers and randomized using computerized software Both the investigators and patients will remain unaware of the composition of the distension medium to ensure blinding
A total of 160 patients will be included in the sample size resulting in a net total of 80 patients per group as described below Patients who choose to withdraw from the study will still be analyzed as intention-to-treat patients
Inclusion Criteria
All patients admitted to the OBGYN Assuta Ashdod Hospital for elective surgical termination of pregnancy due to missed miscarriages in the first trimester with gestational age range of 60 to 116 weeks
Patients aged 18 years and older who are capable to provide informed consent
Exclusion criteria
individual intolerance to oxytocin
mullerian anomalies
Fibroid uterus
thrombophilia or coagulation disorders
cardiovascular disease
Primary outcome
Perioperative Blood Loss Assessment
We will assess perioperative blood loss by
Measuring the content collected in the vacuum apparatus after the procedure
Recording hemoglobin and hematocrit levels prior to the procedure
Measuring hemoglobin and hematocrit levels immediately after the procedure
Monitoring hemoglobin and hematocrit levels two weeks post-procedure
Secondary outcomes
-perioperative complications according to the Dindo-Clavien scale
This study is a prospective randomized placebo-controlled double-blind trial Women undergoing dilation and curettage who meet the eligibility criteria for the study will be divided into two groups They will receive the assigned medication at the beginning of the procedure after cervical dilation but before using suction curettage
Group 1 Participants will receive 100 ml of saline alone Group 2 Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline
The medication bags will be prepared by the Assuta Ashdod University Hospital Pharmacy coded with serial numbers and randomized using computerized software Both the investigators and patients will remain unaware of the composition of the distension medium to ensure blinding
A total of 160 patients will be included in the sample size resulting in a net total of 80 patients per group as described below Patients who choose to withdraw from the study will still be analyzed as intention-to-treat patients
Inclusion Criteria
All patients admitted to the OBGYN Assuta Ashdod Hospital for elective surgical termination of pregnancy due to missed miscarriages in the first trimester with gestational age range of 60 to 116 weeks
Patients aged 18 years and older who are capable to provide informed consent
Exclusion criteria
individual intolerance to oxytocin
mullerian anomalies
Fibroid uterus
thrombophilia or coagulation disorders
cardiovascular disease
Primary outcome
Perioperative Blood Loss Assessment
We will assess perioperative blood loss by
Measuring the content collected in the vacuum apparatus after the procedure
Recording hemoglobin and hematocrit levels prior to the procedure
Measuring hemoglobin and hematocrit levels immediately after the procedure
Monitoring hemoglobin and hematocrit levels two weeks post-procedure
Secondary outcomes
-perioperative complications according to the Dindo-Clavien scale
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None