Labor ComplicationNCT05339399
4 Versus 6 cm Active Phase of Labour
An observational study of Labor Complication and Cervix; Open, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
A study to compare maternal and perinatal outcome between 4 and 6 cm cervical dilatation at amniotomy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Labor Complication, Cervix; Open
- What is being tested?
- oxytocin augmentation
- How many people
- 155 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 May 2021to 10 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
Study population: Low risk pregnant women who delivers in our centre
Who may be able to join
- singleton pregnancy
- no medical disorders
- no antenatal complications such as hypertension and diabetes
Who cannot join
- fetal anomaly
- one previous caesarean section
- other uterine scars
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Labor Complication, Cervix; Open
- Being tested
- oxytocin augmentation
- Keywords
- active labour, 4 and 6 cm, low risk women
- Medical subject headings
- Obstetric Labor Complications, Uterine Cervical Incompetence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocin augmentationOther
Only observation of the outcome
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: oxytocin augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caesarean section rate
in percentage
Measured: from recruitment up to birth of neonate
Secondary outcomes (4)
duration from amniotomy until delivery
duration in minutes from recruitment until delivery
Measured: from recruitment until up to delivery of neonate
oxytocin augmentation
percentage of those who required
Measured: from recruitment until up to delivery of neonate
Percentage of women with complications
complications such as postpartum haemorrhage and extended perineal tear
Measured: from recruitment until up to 6 weeks post delivery
Percentage of neonates with complications
neonatal intensive care unit admission, Apgar score less than 7 at 5 minutes and cord pH <7.24
Measured: from birth of neonate up tom 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 May 2021
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rahana Abd Rahman, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339399
- Sponsor's protocol ID
- FF-2021-173
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4 Versus 6 cm Cervical os Dilatation to Demarcate Active Phase of Labour: Comparative Cross Ectional Study
- ClinicalTrials.gov ID
- NCT05339399
- Acronym / sponsor ID
- FF-2021-173
- Conditions
- Labor Complication, Cervix; Open
- Keywords
- active labour, 4 and 6 cm, low risk women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 cm cervical os dilatation | – | Other: oxytocin augmentationLow risk women with cervical os dilatation of 4 cm at amniotomy and whether they need oxytocin augmentation and analgesia. |
| 6 cm cervical os dilatation | – | Other: oxytocin augmentationLow risk women with cervical os dilatation of 6 cm at amniotomy and whether they need oxytocin augmentation and analgesia. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Low risk pregnant women who delivers in our centre
Key inclusion criteria (3 listed)
- singleton pregnancy
- no medical disorders
- no antenatal complications such as hypertension and diabetes
Key exclusion criteria (3 listed)
- fetal anomaly
- one previous caesarean section
- other uterine scars
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxytocin augmentationOnly observation of the outcome | Other | 4 cm cervical os dilatation, 6 cm cervical os dilatation |
Primary outcome
Caesarean section rate
Time frame: from recruitment up to birth of neonate
in percentage
4 secondary outcomes
duration from amniotomy until delivery
Time frame: from recruitment until up to delivery of neonate
oxytocin augmentation
Time frame: from recruitment until up to delivery of neonate
Percentage of women with complications
Time frame: from recruitment until up to 6 weeks post delivery
Percentage of neonates with complications
Time frame: from birth of neonate up tom 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahana Abd Rahman principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Complication and Cervix; Open, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caesarean section rate (time frame: from recruitment up to birth of neonate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.