NCT04328870

Brief Summary

To determine if combining intravenous oxytocin infusion and spinal anesthesia will reduce the amount of glycine absorption in patients undergoing operative hysteroscopy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

March 25, 2020

Last Update Submit

March 30, 2020

Conditions

Fluid Overload

Outcome Measures

Primary Outcomes (1)

  • fluid overload

    Fluid (glycine) excessive absorption into the patient

    16 months

Study Arms (2)

oxytocin and spinal anesthesia

ACTIVE COMPARATOR

spinal anesthesia combined with intravenous oxytocin infusion

Other: oxytocin and spinal anesthesia

general anesthsia

ACTIVE COMPARATOR

general anesthesia alone

Other: General anesthsia

Interventions

oxytocin and spinal anesthesiaOTHER

start oxytocin 10 IU/200 ml saline at the insertion of the spinal anesthesia

oxytocin and spinal anesthesia
General anesthsiaOTHER

General anesthesia alone.

general anesthsia

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspre-menopausal
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • premenopausal with no cardiovascular comorbidities

You may not qualify if:

  • endometrial cancer cases, patients who received pre-operative hormonal preparations, previously resected cases and cases done using bipolar diathermy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jordan

Amman, 11942, Jordan

Location

MeSH Terms

Conditions

Edema

Interventions

OxytocinAnesthesia, Spinal

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Abdelkarim ALoweidi, consultant

    jordan university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor and Consultant

Study Record Dates

First Submitted

March 25, 2020

First Posted

March 31, 2020

Study Start

May 20, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

on reasonable request

Locations

JO(1)