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OpenTrials
Completed

NCT Number: NCT05339399

4 Versus 6 cm Active Phase of Labour

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

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Key information

Conditions

Labor Complication Abortion, Habitual Abortion, Spontaneous Cervix; Open Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Obstetric Labor Complications Pregnancy Complications Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Incompetence Uterine Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

National University of Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oxytocin augmentation

Other

Only observation of the outcome

Primary outcomes

  1. Caesarean section rate

    Time frame: from recruitment up to birth of neonate

    in percentage

Secondary outcomes

  1. duration from amniotomy until delivery

    Time frame: from recruitment until up to delivery of neonate

    duration in minutes from recruitment until delivery

  2. oxytocin augmentation

    Time frame: from recruitment until up to delivery of neonate

    percentage of those who required

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2022
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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