An interventional study of Oxytocin and Sodium Chloride 0.9% Inj in Missed Abortion, sponsored by Assuta Ashdod Hospital. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by Assuta Ashdod Hospital · Not applicable, Interventional, and Prevention
The aim of this study is to investigate the impact of oxytocin on perioperative blood loss during the D\&C procedure, as well as to assess early and late complications associated with it's use.
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 6.0 to 11.6 weeks.
Patients aged 18 years and older who are capable to provide informed consent.
Exclusion criteria
Primary outcome
Perioperative Blood Loss Assessment:
We will assess perioperative blood loss by:
Secondary outcomes
-perioperative complications according to the Dindo-Clavien scale
53 studies on the registry are indexed under Abortion, Missed; 10 are open to participants now.
This study's planned enrollment of 160 is above the median of 142 across 44 interventional studies indexed under Abortion, Missed.
Browse Abortion, Missed studies →Assuta Ashdod Hospital is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged 18 years and older who are capable to provide informed consent.
Exclusion Criteria:
Participants will receive 100 ml of saline alone.
Drug: Sodium Chloride 0.9% Inj
Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.
Drug: Oxytocin · Drug: Sodium Chloride 0.9% Inj
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.
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.
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.
Time frame: 14 days
perioperative complications according to the Dindo-Clavien scale
perioperative complications according to the Dindo-Clavien scale
Time frame: 30 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Assuta Ashdod Hospital