Cervical LengthNCT04922671
Development of a Screening Tool By Utilising Cervical Length Measurement In Relation To Body Mass Index (BMI) For Early Identification And Intervention Of Preterm Birth
An observational study of Cervical Length and Preterm Birth, run by Universiti Putra Malaysia at 2 sites in Malaysia.
Trial summary
This is a prospective study where pregnant women between 16-24 weeks gestation attending the Antenatal Clinic, Fetomaternal clinic or Obstetrics \& Gynaecology Admission Centre (OGAC) at Hospital Serdang or Hospital Pengajar UPM will be recruited. BMI will be taken both during booking of pregnancy and at recruitment. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Length, Preterm Birth
- How many people
- 145 participants
- Where
- 2 sitesMalaysia
- Study dates
- 1 Jun 2021to 31 Oct 2023
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Antenatal women between 16-24 weeks gestation attending the Antenatal Clinic, Fetomaternal clinic or Obstetrics \& Gynaecology Admission Centre (OGAC) at Hospital Serdang or Hospital Pengajar UPM
Who may be able to join
- Singleton pregnancy between 16-24 weeks gestation
- No history of previous spontaneous preterm birth (gestation between 24-36+6 weeks)
- Agreement to follow up and consented for the study
Who cannot join
- Major fetal anomaly
- Multiple pregnancy
- Uterine anatomic malformation
- Those require iatrogenic preterm delivery due to various condition
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites
Hospital Pengajar UPM
Serdang, Selangor, 43400
Hospital Serdang
Serdang, Selangor, 43400
About this study
Official title: Towards Development of an Individualised Screening Tool By Utilising Cervical Length Measurement In Relation To Body Mass Index (BMI) For Early Identification And Intervention Of Preterm Birth
This is a prospective study where pregnant women between 16-24 weeks gestation attending the Antenatal Clinic, Fetomaternal clinic or Obstetrics \& Gynaecology Admission Centre (OGAC) at Hospital Serdang or Hospital Pengajar UPM will be recruited. BMI will be taken both during booking of pregnancy and at recruitment. Cervical length will be measured via transvaginal scan at recruitment time. We aim to assess the association between body mass index, cervical length and risk of preterm birth.
Read the detailed description
General Objective To assess the association between body mass index, cervical length and risk of preterm birth.
Specific Objectives
- To examine the relationship between body mass index and cervical length
- To identify cut-off value of cervical length leading to high risk of spontaneous preterm birth among Malaysian women
- To assess the association between different cervical length and preterm birth
- To examine the association between body mass index and preterm birth
- To develop an individualised screening tool for assessing risk of preterm birth
- Conditions
- Cervical Length, Preterm Birth
- Keywords
- body mass index, preterm labour, preterm birth, cervical length
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature
What is being measured
The primary outcome is the main question the study is designed to answer.
1. To examine the relationship between body mass index (BMI) and cervical length (CL)
Association of BMI and CL
Measured: till February 2023
2. To identify cut-off value of cervical length
Value leading to high risk of spontaneous preterm birth among Malaysian women
Measured: till February 2023
3. To assess the association between different cervical length and preterm birth
Association of CL and PTB
Measured: till February 2023
4. To examine the association between body mass index and preterm birth
Association of BMI and PTB
Measured: till February 2023
5. To develop an individualised screening tool for assessing risk of preterm birth
Attributable risk of preterm birth with relation to BMI and CL
Measured: Till May 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jun 2021
- Primary completion28 Feb 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical LengthStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurul Iftida Binti Basri, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922671
- Sponsor's protocol ID
- GM-IPM/2021/9695300
- Status last verified
- Nov 2023
- First submitted
- 8 Jun 2021
- Last updated
- 3 Nov 2023
- 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 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Development of an Individualised Screening Tool By Utilising Cervical Length Measurement In Relation To Body Mass Index (BMI) For Early Identification And Intervention Of Preterm Birth
- ClinicalTrials.gov ID
- NCT04922671
- Acronym / sponsor ID
- GM-IPM/2021/9695300
- Conditions
- Cervical Length, Preterm Birth
- Keywords
- body mass index, preterm labour, preterm birth, cervical length
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 10 Jun 2021 (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 is a prospective study where pregnant women between 16-24 weeks gestation attending the Antenatal Clinic, Fetomaternal clinic or Obstetrics \& Gynaecology Admission Centre (OGAC) at Hospital Serdang or Hospital Pengajar UPM will be recruited. BMI will be taken both during booking of pregnancy and at recruitment. Cervical length will be measured via transvaginal scan at recruitment time. We aim to assess the association between body mass index, cervical length and risk of preterm birth.
Detailed description
General Objective To assess the association between body mass index, cervical length and risk of preterm birth.
Specific Objectives
- To examine the relationship between body mass index and cervical length
- To identify cut-off value of cervical length leading to high risk of spontaneous preterm birth among Malaysian women
- To assess the association between different cervical length and preterm birth
- To examine the association between body mass index and preterm birth
- To develop an individualised screening tool for assessing risk of preterm birth
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Antenatal women between 16-24 weeks gestation attending the Antenatal Clinic, Fetomaternal clinic or Obstetrics \& Gynaecology Admission Centre (OGAC) at Hospital Serdang or Hospital Pengajar UPM
Key inclusion criteria (3 listed)
- Singleton pregnancy between 16-24 weeks gestation
- No history of previous spontaneous preterm birth (gestation between 24-36+6 weeks)
- Agreement to follow up and consented for the study
Key exclusion criteria (4 listed)
- Major fetal anomaly
- Multiple pregnancy
- Uterine anatomic malformation
- Those require iatrogenic preterm delivery due to various condition
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
1. To examine the relationship between body mass index (BMI) and cervical length (CL)
Time frame: till February 2023
Association of BMI and CL
2. To identify cut-off value of cervical length
Time frame: till February 2023
Value leading to high risk of spontaneous preterm birth among Malaysian women
3. To assess the association between different cervical length and preterm birth
Time frame: till February 2023
Association of CL and PTB
4. To examine the association between body mass index and preterm birth
Time frame: till February 2023
Association of BMI and PTB
5. To develop an individualised screening tool for assessing risk of preterm birth
Time frame: Till May 2023
Attributable risk of preterm birth with relation to BMI and CL
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 3 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Length and Preterm Birth, run by Universiti Putra Malaysia at 2 sites 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 4 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 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
1. To examine the relationship between body mass index (BMI) and cervical length (CL) (time frame: till February 2023). The study lists 5 primary outcomes in all. 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 3 Nov 2023.