Effect of Glucose 5% on Labor Length | NCT04492150

Studies
Effect of Glucose 5% on Labor Length

NCT04492150

Sponsor

Suez Canal University

Status

Unknown status

Last Update Posted

Jul 30, 2020Actual

Enrollment

476Estimated

Phase

Not Applicable

Conditions

Induction of Labor Affected Fetus / Newborn

Interventions

Dextrose 5%/Nacl 0.3% Inj_#3
Saline

Countries

Egypt

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

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 9, 2019Actual

Primary Completion Date

Sep 10, 2020Estimated

Completion Date

Oct 10, 2020Estimated

First Submitted Date

Jul 27, 2020

First Submission Date that Met QC Criteria

Jul 27, 2020

First Posted Date

Jul 30, 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

Jul 27, 2020

Last Update Posted Date

Jul 30, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Salwa Hussein Ismaeil Tammam, principal investigator, Suez Canal UniversityPrincipal Investigator

Lead Sponsor

Suez Canal UniversityOTHER

Collaborators

Not provided

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

Induction of labor, is one of the most common obstetric procedures done routinely in modern obstetrics. For example, in USA, 23% of pregnant women in 2012 (about 1 million) underwent an induction of labor. However, accurate data about percentage of women undergoing induction of labor in Egypt is not accurately known.

One of the recent research era in current obstetrics is the optimal intravenous (IV) hydration of the pregnant women in labor.Current evidences available in our hands, suggest that maternal hydration appears to fasten labor progress and enhance the action of oxytocin, if the later is used for augmentation. However, the addition of glucose supplementation to this IV hydration to enhance uterine contraction, as a matter of safety and efficacy, is controversial

Detailed Description

Not provided

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

476Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group	Experimental	women who will receive 250 mL/hour of dextrose 5% with normal saline in a 1:1 ratio.	Drug: Dextrose 5%/Nacl 0.3% Inj_#3 Drug: Saline
control group	Active Comparator	women who will receive 250 mL/hour of normal saline for the whole duration of induction	Drug: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dextrose 5%/Nacl 0.3% Inj_#3	Drug	250 mL/hour of dextrose 5% intravenous drip	study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the duration of labor	the duration from the beginning of active labor (cervical exam between 3 and 5 cm with regular uterine contractions) to fetal delivery, reported in minutes.	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Rate of cesarean sections	the number of cases delivered by cesarean section	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult (>18 years) multiparous women
Late Term Pregnancy ( gestational Age Between 40-42 weeks)
Uncomplicated singleton pregnancy with cephalic presentation.
Favorable cervix for induction (Bishop score<6) without ruptured membranes.

Exclusion Criteria:

Women with chronic diseases or complicated pregnancy; gestational and pre gestational ( type 1 & 2)diabetes, preeclampsia and\or renal and\or maternal heart diseases.
Non-cephalic presentations, multiple pregnancies, or cervix unfavorable for induction.
Other indications for cesarean delivery

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Salwa H Tammam, M. B. B. Ch	Contact	00201012869258		Dr.salwa.hussein.tammam@gmail.com

Overall Officials

Name	Affiliation	Role
Zakia M Ibraheim, MD	Professor of Gynecology and Obstetrics	Study Chair
Mariam L Mohammed, MD	Assistant Professor of Gynecology and Obstetrics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Suez canal University	Recruiting	Ismailia			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005947	Glucose
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates
D002712

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Browse Branches

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