4 Versus 6 cm Active Phase of Labour

April 21, 2022 updated by: National University of Malaysia

4 Versus 6 cm Cervical os Dilatation to Demarcate Active Phase of Labour: Comparative Cross Ectional Study

A study to compare maternal and perinatal outcome between 4 and 6 cm cervical dilatation at amniotomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Low risk women with singleton pregnancy are recruited. There are two groups which are 4 and 6 cm cervical os dilatation. The intrapartum management and labour outcomes are documented.

Study Type

Observational

Enrollment (Actual)

155

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • National University of Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Low risk pregnant women who delivers in our centre

Description

Inclusion Criteria:

  • singleton pregnancy
  • no medical disorders
  • no antenatal complications such as hypertension and diabetes

Exclusion Criteria:

  • fetal anomaly
  • one previous caesarean section
  • other uterine scars

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
4 cm cervical os dilatation
Low risk women with cervical os dilatation of 4 cm at amniotomy and whether they need oxytocin augmentation and analgesia.
Other: oxytocin augmentation
Only observation of the outcome
6 cm cervical os dilatation
Low risk women with cervical os dilatation of 6 cm at amniotomy and whether they need oxytocin augmentation and analgesia.
Other: oxytocin augmentation
Only observation of the outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caesarean section rate
Time Frame: from recruitment up to birth of neonate
in percentage
from recruitment up to birth of neonate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration from amniotomy until delivery
Time Frame: from recruitment until up to delivery of neonate
duration in minutes from recruitment until delivery
from recruitment until up to delivery of neonate
oxytocin augmentation
Time Frame: from recruitment until up to delivery of neonate
percentage of those who required
from recruitment until up to delivery of neonate
Percentage of women with complications
Time Frame: from recruitment until up to 6 weeks post delivery
complications such as postpartum haemorrhage and extended perineal tear
from recruitment until up to 6 weeks post delivery
Percentage of neonates with complications
Time Frame: from birth of neonate up tom 7 days
neonatal intensive care unit admission, Apgar score less than 7 at 5 minutes and cord pH <7.24
from birth of neonate up tom 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

February 10, 2022

Study Completion (Actual)

February 10, 2022

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 14, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF-2021-173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Labor Complication

Clinical Trials on oxytocin augmentation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe