Oxytocin Effectiveness in First Trimester Dilatation and Curettage - a Double Blind Placebo Controlled Randomized Trial

Missed Abortion Clinical Trial

Official title:

Oxytocin Effectiveness in First Trimester Dilatation and Curettage - a Double Blind Placebo Controlled Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06469203
• Other study ID #: 0127-23-AAA
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: June 2024
• Source: Assuta Ashdod Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 three days post-procedure.

Secondary outcomes

-perioperative complications according to the Dindo-Clavien scale

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Missed
• Missed Abortion

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Ashdod Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 three days post-procedure.	3 days
Secondary	perioperative complications according to the Dindo-Clavien scale	perioperative complications according to the Dindo-Clavien scale	3 days