Paperless Parotograph in Evaluation of Labour | NCT03272282

Studies
Paperless Parotograph in Evaluation of Labour

NCT03272282

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Sep 6, 2017Actual

Enrollment

450Estimated

Phase

Not provided

Conditions

Labor Complication

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2017Actual

Primary Completion Date

Sep 12, 2017Estimated

Completion Date

Sep 12, 2017Estimated

First Submitted Date

Aug 23, 2017

First Submission Date that Met QC Criteria

Aug 31, 2017

First Posted Date

Sep 5, 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 1, 2017

Last Update Posted Date

Sep 6, 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

Using Paperless partograph management of labour as simple tool to prevent obstructed labour or prolonged labour or its complications at the mother or her fetus

Detailed Description

WHO PARTOGRAPH is very work load need more time and more stuff in both treaning and learning for plotting and for drowning but inside labour room needing simple partograph playing the simple partograph beast role in management of labour and stand test against time for saving live of labour women and her child Paperless parotograph can help obestitricianes to talk decision about when to transferr the labourus women to higher centers on to make medical intervention or what time to end labour by caesarian section

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

450Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progress of labour	Cervical dilatation 1 cm / hour	up to 5 months

Secondary Outcomes

Measure	Description	Time Frame
Charcteristics of new_born	Apgar score at1minute and Apgar score at 5minutes	up to 1 month
Time taken after ALERT EDT	Primgravida and Multipara

Other Outcomes

Measure	Description	Time Frame
Mode of delivery	Normal vaginal delivery or caesarean section	up to 9 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women ln active phase of labour
With single pregnanncy
living fetus
cephalic presentation
occipt anterior
36 weak gestional age up to full term

Exclusion Criteria:

preterm . .or women with antipartum hemorrhage .
or multipregnanncy
previous utrine surgery
or abnormal cardiotocograph(CTG )PATTERN
or any heart disease of mother or his fetus

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women ln active phase of labour cerivical dilution 4cm or more

Minimum Age

20 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

By following women during labour using well structured questions developed by researcher and filling well designed Paperless partograph stumped THE collected data will be analysed using special computer program SPSS tactical program for social science

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
abobaker khalil	Contact	00201003568474		kotbnetw@hotmail.com
said mostafa	Contact	00201007599819		saidmostafy9@gmail.com

Overall Officials

Name	Affiliation	Role
mohamed khalaph	assiut universty faculity of medicine	Study Director
ahmad abass	assiut university faclity of meficibe	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculity of Medicine Assiut University	Recruiting	Asyut	Asyut Governorate	71723	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24614997	Result	Fatehi F, Gray LC, Wootton R. How to improve your PubMed/MEDLINE searches: 3. advanced searching, MeSH and My NCBI. J Telemed Telecare. 2014 Mar;20(2):102-12. doi: 10.1177/1357633X13519036.
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.

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