Fluid Absorption in Patients Undergoing Operative Hystero... | NCT04328870

Studies
Fluid Absorption in Patients Undergoing Operative Hysteroscopy; Results From a Prospective Controlled Study

NCT04328870

Sponsor

University of Jordan

Status

Completed

Last Update Posted

Mar 31, 2020Actual

Enrollment

88Actual

Phase

Not Applicable

Conditions

Fluid Overload

Interventions

oxytocin and spinal anesthesia
General anesthsia

Countries

Jordan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2018Actual

Primary Completion Date

Sep 30, 2019Actual

Completion Date

Sep 30, 2019Actual

First Submitted Date

Mar 25, 2020

First Submission Date that Met QC Criteria

Mar 30, 2020

First Posted Date

Mar 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2020

Last Update Posted Date

Mar 31, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Prospective controlled study in premenopausal patients who had hysteroscopic surgery including endometrial resection, endometrial polypectomy, myomectomy resection and uterine septal resection. The effect of combined spinal anesthetic with oxytocin infusion on fluid deficit was studied.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
oxytocin and spinal anesthesia	Other	start oxytocin 10 IU/200 ml saline at the insertion of the spinal anesthesia	oxytocin and spinal anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fluid overload	Fluid (glycine) excessive absorption into the patient	16 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

premenopausal with no cardiovascular comorbidities

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pre-menopausal

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abdelkarim ALoweidi, consultant	jordan university	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Jordan		Amman		11942	Jordan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

on reasonable request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004487	Edema

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010121	Oxytocin
D000775	Anesthesia, Spinal

Ancestor Terms

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided