Wide Use of Paperless Partograph in Evaluation of Labour | NCT03276117

Studies
Wide Use of Paperless Partograph in Evaluation of Labour

NCT03276117

Sponsor

Assiut University

Status

Completed

Last Update Posted

Sep 8, 2017Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Labor Complication
Labor Pain

Interventions

Not provided

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

Sep 2017

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

Feb 2, 2017Actual

Primary Completion Date

Aug 21, 2017Actual

Completion Date

Aug 26, 2017Actual

First Submitted Date

Sep 4, 2017

First Submission Date that Met QC Criteria

Sep 6, 2017

First Posted Date

Sep 8, 2017Actual

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

Sep 6, 2017

Last Update Posted Date

Sep 8, 2017Actual

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

Paperless partograph wide using in labour room as simple tool in evaluation of labour

Detailed Description

Both world health organization ( WHO) PARTOGRAPH and modified world heath organization (WHO)PARTOGRAPH are too long labour tools in evaluation of labour so we need simple tool in evaluation of labour

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progress of labour	Cervical dilated 1 cm each hour	up to 2 month

Secondary Outcomes

Measure	Description	Time Frame
New born	Apgar scor at 1 minute and Apgar scor at 5 minutes	up to 1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Spontaneous labour
cephalic presentation
pregnant 37 weeks up to full term

Exclusion Criteria:

mail_presentation
induced labour

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

the collected data wail be analyzed using the statistical package for social science (version 10.0 for windows,SPSS.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
mohamed khalaph, professor	assiut universty faculity of medicine	Study Chair
ahmad abass, professor	assiut university faclity of meficibe	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculity of Medicine ,in Assiut,Egypt		Asyut		71723	Egypt
Faculity of Medicine Assiut University

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8343701	Result	Jadad AR, McQuay HJ. Searching the literature. Be systematic in your searching. BMJ. 1993 Jul 3;307(6895):66. doi: 10.1136/bmj.307.6895.66-a. No abstract available.
16467730	Result	Chang AA, Heskett KM, Davidson TM. Searching the literature using medical subject headings versus text word with PubMed. Laryngoscope. 2006 Feb;116(2):336-40. doi: 10.1097/01.mlg.0000195371.72887.a2.

ID	Term
D007744	Obstetric Labor Complications
D048949	Labor Pain

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D010146	Pain