4 Versus 6 cm Active Phase of Labour

Labor Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05339399
• Other study ID #: FF-2021-173
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: April 2022
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervix; Open
• Labor Complication
• Obstetric Labor Complications

Intervention

Other:
• oxytocin augmentation
Only observation of the outcome

Locations

Country	Name	City	State
Malaysia	National University of Malaysia	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caesarean section rate	in percentage	from recruitment up to birth of neonate
Secondary	duration from amniotomy until delivery	duration in minutes from recruitment until delivery	from recruitment until up to delivery of neonate
Secondary	oxytocin augmentation	percentage of those who required	from recruitment until up to delivery of neonate
Secondary	Percentage of women with complications	complications such as postpartum haemorrhage and extended perineal tear	from recruitment until up to 6 weeks post delivery
Secondary	Percentage of neonates with complications	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