NCT06575387

Brief Summary

The partograph serves as "early warning system" and it has shown to be effective in preventing prolonged labour, in reducing operative interventions and in improving the neonatal outcome. "A picture is worth a thousand words". A partograph review if well recorded provides rapid and comprehensive information about progress of labour when compared with a review of detailed handwritten case sheets. Partograph is a Latin/Greek hybrid word synonymous with parturition recorded in a graphic form.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
Last Updated

August 29, 2025

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

August 25, 2024

Last Update Submit

August 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mode of Delivery

    The mode of delivery was assessed by the condition of the mother and the fetus by BISHOP score (The Bishop score is a cervical assessment system used to predict the success of labor induction. This scoring system evaluates several clinical parameters of the cervix, including dilation, effacement, position, consistency, and the fetal head's station in the pelvis).

    24 hours

Study Arms (3)

Group A: Uncomplicated Normal Labour

ACTIVE COMPARATOR

About 140 prime gravidae females delivered before or at alert line

Procedure: Partogram

Group B: Complicated Normal Labour

ACTIVE COMPARATOR

About 40 prime gravidae females delivered between alert and action line

Procedure: Partogram

Group C: Cesarean Section Labour

ACTIVE COMPARATOR

About 20 prime gravidae females delivered after action line

Procedure: Partogram

Interventions

PartogramPROCEDURE

to evaluate the utility of partogram in management and progress of active labor in Primigravidae.

Group A: Uncomplicated Normal LabourGroup B: Complicated Normal LabourGroup C: Cesarean Section Labour

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primigravida, 20 and 35 years old
  • Gestational age 37 - 41 weeks with vertex presentation
  • Singleton pregnancy
  • Spontaneous or induced labour
  • First stage of labour with cervical dilatation \< than 7 cm.

You may not qualify if:

  • Abnormal presentation
  • Macrosomic baby
  • Contacted pelvis
  • Multifetal gestations
  • Antepartum haemorrhage
  • Cases with high risk pregnancy as Severe PIH, Severe anaemia and gestational diabetes mellitus.
  • Patient refused to enrolled in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University hospitals

Asyut, Egypt

Location

Study Officials

  • Abd El-Aziz Galal El-Din El-Darwish, Professor

    Al-Azhar University, Faculty of medicine, Assuit.

    STUDY CHAIR
  • Khaled Mohamed Ahmed M. Abdallah, Assist.Professor

    Al-Azhar University, Faculty of medicine, Assuit.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2024

First Posted

August 28, 2024

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 10, 2024

Last Updated

August 29, 2025

Record last verified: 2023-09

Locations