Oxytocin Effectiveness in First Trimester Dilatation and Curettage

NCT06469203 | Not Yet Recruiting DMC

• 1 other identifier: 0127-23-AAA
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Missed Abortion

Keywords

missed abortion; vaginal bleeding; dilation and curretage; pregnancy termination; oxytocin

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days

Secondary Outcomes (1)

• perioperative complications according to the Dindo-Clavien scale

  30 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will receive 100 ml of saline alone.

Drug: Sodium Chloride 0.9% Inj

Oxytocin

EXPERIMENTAL

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

Interventions

Oxytocin 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

Sodium Chloride 0.9% Inj 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; Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: including pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assuta Ashdod Hospital: lead

MeSH Terms

Conditions

Abortion, Missed; Uterine Hemorrhage; Dilatation, Pathologic

Interventions

Oxytocin; Sodium Chloride

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: randomization will be done by hospitals pharmacy. 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 21, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share