4 Versus 6 cm Active Phase of Labour

Completed

• Conditions: Labor Complication; Cervix; Open
• Interventions: Other: oxytocin augmentation

• Registration Number: NCT05339399
• Lead Sponsor: National University of Malaysia

Brief Summary

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

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 Timeline

• Study Start: 2021-05-01
• Primary Completion: 2022-02-10
• Study Completion: 2022-02-10
• Status Verified: 2022-04
• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-21
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 155

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
4 cm cervical os dilatation	oxytocin augmentation	Low risk women with cervical os dilatation of 4 cm at amniotomy and whether they need oxytocin augmentation and analgesia.
6 cm cervical os dilatation	oxytocin augmentation	Low risk women with cervical os dilatation of 6 cm at amniotomy and whether they need oxytocin augmentation and analgesia.

Primary Outcome Measures

Name	Time	Method
Caesarean section rate	from recruitment up to birth of neonate	in percentage

Secondary Outcome Measures

Name	Time	Method
duration from amniotomy until delivery	from recruitment until up to delivery of neonate	duration in minutes from recruitment until delivery
oxytocin augmentation	from recruitment until up to delivery of neonate	percentage of those who required
Percentage of women with complications	from recruitment until up to 6 weeks post delivery	complications such as postpartum haemorrhage and extended perineal tear
Percentage of neonates with complications	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

Trial Locations

Locations (1)

National University of Malaysia; 🇲🇾 Cheras, Kuala Lumpur, Malaysia