NCT05339399

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

April 6, 2022

Last Update Submit

April 21, 2022

Conditions

Labor ComplicationCervix; Open

Keywords

active labour4 and 6 cmlow risk women

Outcome Measures

Primary Outcomes (1)

  • Caesarean section rate

    in percentage

    from recruitment up to birth of neonate

Secondary Outcomes (4)

  • duration from amniotomy until delivery

    from recruitment until up to delivery of neonate

  • oxytocin augmentation

    from recruitment until up to delivery of neonate

  • Percentage of women with complications

    from recruitment until up to 6 weeks post delivery

  • Percentage of neonates with complications

    from birth of neonate up tom 7 days

Study Arms (2)

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

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

Interventions

oxytocin augmentationOTHER

Only observation of the outcome

4 cm cervical os dilatation6 cm cervical os dilatation

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Low risk pregnant women who delivers in our centre

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Obstetric Labor ComplicationsUterine Cervical Incompetence

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesAbortion, HabitualAbortion, SpontaneousGenital Diseases

Study Officials

  • Rahana Abd Rahman

    National University of Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 21, 2022

Study Start

May 1, 2021

Primary Completion

February 10, 2022

Study Completion

February 10, 2022

Last Updated

April 29, 2022

Record last verified: 2022-04

Locations

MY(1)