Induction of LabourNCT04477226
Transvaginal Ultrasound As Predictors of Successful Induction of Labour
An observational study of Induction of Labour, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial summary
To compare the use of transvaginal ultrasound (TVUS) of cervix to the Bishops score prior to induction of labour in term pregnancies, and the ability to predict Caesarean delivery for failure to progress. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Induction of Labour
- What is being tested?
- Transvaginal ultrasound scan
- How many people
- 294 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2019to 31 Dec 2019
- 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: All patients who are admitted for induction of labour and fulfils the criteria will be recruited from Patient Admission Centre (PAC), antenatal ward, labour room
Who may be able to join
- Nulliparous or multipara
- Singleton live pregnancy
- Gestational age between 37 - 42 weeks
- Cephalic presentation
- Intact membranes
- Reactive cardiotocograph tracing
- Low risk pregnancy
Who cannot join
- Previous history of uterine surgery
- Low lying placenta, placenta praevia and vaginal bleeding
- Multiple pregnancy
- Preterm Prelabour rupture of membrane/ prelabour rupture of membranes
- Known allergy towards prostaglandins
- Intrauterine fetal death
Show all 12Show fewer
- Known fetal anomaly
- Estimated fetal weight >3.8kg by scan
- Grandmultiparity (more than 5)
- BMI >40kg/m2
- Diabetes and hypertension on treatment
- Other medical illness on treatment
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Universiti Kebangsaan Malaysia Medical Centre
Kuala Lumpur, 56000
About this study
Official title: Pre-Induction Cervical Assessment Using Transvaginal Ultrasound Versus Bishop's Cervical Scoring in Term Pregnancies As Predictors of Successful Induction of Labour
To compare the use of transvaginal ultrasound (TVUS) of cervix to the Bishops score prior to induction of labour in term pregnancies, and the ability to predict Caesarean delivery for failure to progress.
Read the detailed description
The aim of this prospective study is to compare the use of transvaginal ultrasound (TVUS) of cervix to the Bishops score prior to induction of labour in term pregnancies, and the ability to predict Caesarean delivery for failure to progress.
- Conditions
- Induction of Labour
- Being tested
- Transvaginal ultrasound scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasound scanDiagnostic test
Transvaginal ultrasound is done to measure the cervical length, as per Fetal Medicine Foundation guidelines
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the optimal cutoff points for cervical length measurement as predictor of successful labour induction
measurement of cervical length in cm
Measured: before induction of labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of LabourStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kah Teik Chew, Principal investigator, UKMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477226
- Sponsor's protocol ID
- FF-2019-368
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Induction Cervical Assessment Using Transvaginal Ultrasound Versus Bishop's Cervical Scoring in Term Pregnancies As Predictors of Successful Induction of Labour
- ClinicalTrials.gov ID
- NCT04477226
- Acronym / sponsor ID
- FF-2019-368
- Conditions
- Induction of Labour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Jul 2020 (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.
To compare the use of transvaginal ultrasound (TVUS) of cervix to the Bishops score prior to induction of labour in term pregnancies, and the ability to predict Caesarean delivery for failure to progress.
Detailed description
The aim of this prospective study is to compare the use of transvaginal ultrasound (TVUS) of cervix to the Bishops score prior to induction of labour in term pregnancies, and the ability to predict Caesarean delivery for failure to progress.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- All patients who are admitted for induction of labour and fulfils the criteria will be recruited from Patient Admission Centre (PAC), antenatal ward, labour room
Key inclusion criteria (7 listed)
- Nulliparous or multipara
- Singleton live pregnancy
- Gestational age between 37 - 42 weeks
- Cephalic presentation
- Intact membranes
Key exclusion criteria (12 listed)
- Previous history of uterine surgery
- Low lying placenta, placenta praevia and vaginal bleeding
- Multiple pregnancy
- Preterm Prelabour rupture of membrane/ prelabour rupture of membranes
- Known allergy towards prostaglandins
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 |
|---|---|---|
| Transvaginal ultrasound scanTransvaginal ultrasound is done to measure the cervical length, as per Fetal Medicine Foundation guidelines | Diagnostic test | – |
Primary outcome
To determine the optimal cutoff points for cervical length measurement as predictor of successful labour induction
Time frame: before induction of labour
measurement of cervical length in cm
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 20 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Kah Teik Chew principal investigator
UKMMC
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 Induction of Labour, run by Universiti Kebangsaan Malaysia Medical Centre 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 7 inclusion and 12 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 20 Jul 2020. 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?
To determine the optimal cutoff points for cervical length measurement as predictor of successful labour induction (time frame: before induction of labour). 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 20 Jul 2020.