Oxytocin Effectiveness in First Trimester Dilatation and Curettage

August 12, 2024 updated by: Assuta Ashdod Hospital
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive 100 ml of saline alone.
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.
Experimental: Oxytocin
Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.
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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Blood Loss Assessment
Time Frame: 14 days

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
perioperative complications according to the Dindo-Clavien scale
Time Frame: 30 days
perioperative complications according to the Dindo-Clavien scale
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assuta Ashdod Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0127-23-AAA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Missed Abortion

Clinical Trials on Sodium Chloride 0.9% Inj

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe