NCT03272282

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

January 12, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2017

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

8 months

First QC Date

August 23, 2017

Last Update Submit

September 1, 2017

Conditions

Keywords

WHO PARTOGRAPG.OBSTRUCTED LABOUR. managment of labour

Outcome Measures

Primary Outcomes (1)

  • Progress of labour

    Cervical dilatation 1 cm / hour

    up to 5 months

Secondary Outcomes (2)

  • Charcteristics of new_born

    up to 1 month

  • Time taken after ALERT EDT

    up to 2 months

Other Outcomes (1)

  • Mode of delivery

    up to 9 weeks

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen ln active phase of labour cerivical dilution 4cm or more
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculity of Medicine Assiut University

Asyut, Asyut Governorate, 71723, Egypt

RECRUITING

Faculity of Medicine

Asyut, 71723, Egypt

RECRUITING

Related Publications (3)

  • 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.

  • 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.

  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

By fellowing women during labour when cervical dilation reach 4cm in active phase of labour all women with inclusion criteria are recorded all women with exclusion criteria are excluded

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • mohamed khalaph

    assiut universty faculity of medicine

    STUDY DIRECTOR
  • ahmad abass

    assiut university faclity of meficibe

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 23, 2017

First Posted

September 5, 2017

Study Start

January 12, 2017

Primary Completion

September 12, 2017

Study Completion

September 12, 2017

Last Updated

September 6, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol (prospective auther of journals)Access

Locations