Outcome, Adverse BirthNCT07121491
Effects and Childbirth Experience Between Zhang and WHO Partograph
An observational study of Outcome, Adverse Birth and Childbirth Experience, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
This study compared the labour outcomes and childbirth experience between Zhang and WHO partograph. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Outcome, Adverse Birth, Childbirth Experience
- How many people
- 713 participants
- Where
- 1 siteMalaysia
- Study dates
- 27 Jun 2024to 28 Feb 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All women who fulfil the inclusion criteria
Who may be able to join
- cervical dilatation 4 or 6 cm
- singleton
- cephalic presentation
- at 37 weeks or more
- normal cardiotocograph tracing on admission
- understands Malay or English
Show all 9Show fewer
- no uterine scar
- no pre-existing medical disorders
- no antenatal complications such as diabetes or hypertension
Who cannot join
- multiple pregnancy
- none cephalic presentation
- abnormal admission cardiotocograph tracing
- less than 37 weeks gestation
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Zhang's Guidelines Versus Who Partograph On Childbirth Experience According To Ceq-My
This study compared the labour outcomes and childbirth experience between Zhang and WHO partograph.
Read the detailed description
A prospective cross-sectional observational study that compared the cervical os dilatation i.e 4 and 6 cm upon admission to the labour room. Eligible patients were recruited during postnatal period in the ward before discharged home. The details of clinical characteristics and labour outcomes were collected. Patients then answered the CEQ-My questionnaire form that assess their childbirth experiences. The primary outcome measure was caesarean section rate and the secondary outcome measure was the childbirth experience.
- Conditions
- Outcome, Adverse Birth, Childbirth Experience
- Keywords
- Labour outcome, Childbirth experience
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cervical dilatation 4 cm | Women with cervical dilatation 4 cm | |
| Cervical dilatation 6 cm | Women with cervical dilatation 6 cm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caesarean section rate
Rate of delivery via caesarean section in percentage
Measured: from cervical dilatation of 4 or 6 cm through study completion up to delivery of the foetus
Secondary outcomes (1)
Childbirth experience
Assessment of experience during delivery using questionnaire based on based on total childbirth experience questionnaire score using Likert scale from 1 to 4. Score of 4 is a total agreement and score of 1 is total disagreement.
Measured: from Day 1 throughout study completion, an average of 7 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start27 Jun 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outcome, Adverse BirthStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 713 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahana Abd Rahman, National University of Malaysia
- Investigators
- Rahana Abd Rahman, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121491
- Sponsor's protocol ID
- FF-2024-280
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Zhang's Guidelines Versus Who Partograph On Childbirth Experience According To Ceq-My
- ClinicalTrials.gov ID
- NCT07121491
- Acronym / sponsor ID
- FF-2024-280
- Conditions
- Outcome, Adverse Birth, Childbirth Experience
- Keywords
- Labour outcome, Childbirth experience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 713 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 13 Aug 2025 (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.
This study compared the labour outcomes and childbirth experience between Zhang and WHO partograph.
Detailed description
A prospective cross-sectional observational study that compared the cervical os dilatation i.e 4 and 6 cm upon admission to the labour room. Eligible patients were recruited during postnatal period in the ward before discharged home. The details of clinical characteristics and labour outcomes were collected. Patients then answered the CEQ-My questionnaire form that assess their childbirth experiences. The primary outcome measure was caesarean section rate and the secondary outcome measure was the childbirth experience.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical dilatation 4 cm | – | –Women with cervical dilatation 4 cm |
| Cervical dilatation 6 cm | – | –Women with cervical dilatation 6 cm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women who fulfil the inclusion criteria
Key inclusion criteria (9 listed)
- cervical dilatation 4 or 6 cm
- singleton
- cephalic presentation
- at 37 weeks or more
- normal cardiotocograph tracing on admission
Key exclusion criteria (5 listed)
- multiple pregnancy
- none cephalic presentation
- abnormal admission cardiotocograph tracing
- less than 37 weeks gestation
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Caesarean section rate
Time frame: from cervical dilatation of 4 or 6 cm through study completion up to delivery of the foetus
Rate of delivery via caesarean section in percentage
1 secondary outcome
Childbirth experience
Time frame: from Day 1 throughout study completion, an average of 7 days after delivery
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 13 Aug 2025.
- Individual participant dataSharing planned: Undecided. IPD will be shared upon request
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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 Outcome, Adverse Birth and Childbirth Experience, 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 9 inclusion and 5 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 13 Aug 2025. 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 cervical dilatation of 4 or 6 cm through study completion up to delivery of the foetus). 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 13 Aug 2025.