Oxytocin Effectiveness in First Trimester Dilatation and Curettage

NCT ID: NCT06469203

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-06-30

Brief Summary

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.

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 6.0 to 11.6 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

Conditions

Missed Abortion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Participants will receive 100 ml of saline alone.

Group Type: PLACEBO_COMPARATOR

Sodium Chloride 0.9% Inj

Intervention Type: DRUG

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.

Oxytocin

Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

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.

Sodium Chloride 0.9% Inj

Intervention Type: DRUG

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.

Interventions

Oxytocin

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• individual intolerance to oxytocin
• mullerian anomalies
• Fibroid uterus
• thrombophilia or coagulation disorders
• cardiovascular disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assuta Ashdod Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

0127-23-AAA

Identifier Type: -

Identifier Source: org_study_id