Pre Term BirthNCT02853656
Time to Delivery of Preterm Birth
An observational study of Pre Term Birth, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Preterm birth (babies being born before 34 weeks pregnancy) occurs in approximately 11% of pregnancies; preterm birth can lead to complications for the baby. When mothers are identified as being at risk of going into preterm birth (giving birth within the next 14 days) there are several treatments available that may… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre Term Birth
- How many people
- 128 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to 31 Dec 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women with singleton pregnancy between 22-34 weeks gestation with signs and symptoms of pre term birth
Who may be able to join
- aged ≥ 18 years
- confirmed pregnancy
- gestational age between 22 and 34 weeks
- self-reported signs, symptoms or complaints suggestive of preterm labour;
- abdominal pain
- contractions
- pelvic pressure
Who cannot join
- unable to provide written informed consent
- multiple pregnancy
- participating in an interventional clinical trial
- a symptom not associated with idiopathic threatened preterm delivery (e.g. trauma)
- contraindicated to either fFN or PhIGFBP-1; e.g.
- vaginal bleeding
Show all 11Show fewer
- cervical dilation ≥3cm dilated
- evidence of rupture of membranes
- had intercourse in last 24 hours
- cervical cerclage in situ
- placenta praevia
Trial locations and contacts
1 site in 1 country.
About this study
Preterm birth (babies being born before 34 weeks pregnancy) occurs in approximately 11% of pregnancies; preterm birth can lead to complications for the baby.
When mothers are identified as being at risk of going into preterm birth (giving birth within the next 14 days) there are several treatments available that may help reduce the likelihood of complications for the baby. These treatments usually need to be started within 24 hours so it is very important that diagnosing preterm labour in not only fast but accurate.
Read more
There are several methods commonly used within hospitals for diagnosing mothers who may be at risk of going into preterm labour. The two most common ones are foetal fibronectin (fFN) and phosphorylated insulin-like growth factor binding protein 1 (phIGFBP-1).
The purpose of this study is to compare the two tests to see which is more accurate at predicting preterm birth.
Read the detailed description
Preterm birth (babies being born before 34 weeks pregnancy) occurs in approximately 11% of pregnancies; preterm birth can lead to complications for the baby.
When mothers are identified as being at risk of going into preterm birth (giving birth within the next 14 days) there are several treatments available that may help reduce the likelihood of complications for the baby. These treatments usually need to be started within 24 hours so it is very important that diagnosing preterm labour in not only fast but accurate.
There are several methods commonly used within hospitals for diagnosing mothers who may be at risk of going into preterm labour. The two most common ones are foetal fibronectin (fFN) and phosphorylated insulin-like growth factor binding protein 1 (phIGFBP-1).
The purpose of this study is to compare the two tests to see which is more accurate at predicting preterm birth.
This is a prospective comparative study of fFN (control) and PhIGFBP-1 test (comparator) for women with singleton pregnancies between 22-34 weeks gestation presenting with self-reported signs, symptoms or complaints suggestive of preterm labour.
Both tests will be done on every participant - the tests will be sequenced so that every 5 participants the fFN test is undertaken first and then the next cohort of 5 will have the PhIGFBP-1 swab taken first. This is to remove any potential biases surrounding which test was undertaken first. Data collection (case report forms (CRFs)) will clearly document which test was performed 1st and 2nd.
- Conditions
- Pre Term Birth
- Keywords
- preterm birth, gestation
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of heightened risk of imminent delivery
preterm birth at 7 days
Measured: 7 days
diagnosis of heightened risk of imminent delivery
preterm birth at 14 days
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre Term 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amaju Ikomi, MBBS FRCOG, Study director, Basildon and Thurrock University Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853656
- Sponsor's protocol ID
- B868
- Other IDs
- 194502
- Status last verified
- Jan 2024
- First submitted
- 27 Jul 2016
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Delivery of Preterm Birth
- ClinicalTrials.gov ID
- NCT02853656
- Acronym / sponsor ID
- B868
- Conditions
- Pre Term Birth
- Keywords
- preterm birth, gestation
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 3 Aug 2016 (estimated)
- 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.
Preterm birth (babies being born before 34 weeks pregnancy) occurs in approximately 11% of pregnancies; preterm birth can lead to complications for the baby.
When mothers are identified as being at risk of going into preterm birth (giving birth within the next 14 days) there are several treatments available that may help reduce the likelihood of complications for the baby. These treatments usually need to be started within 24 hours so it is very important that diagnosing preterm labour in not only fast but accurate.
There are several methods commonly used within hospitals for diagnosing mothers who may be at risk of going into preterm labour. The two most common ones are foetal fibronectin (fFN) and phosphorylated insulin-like growth factor binding protein 1 (phIGFBP-1).
The purpose of this study is to compare the two tests to see which is more accurate at predicting preterm birth.
Detailed description
Preterm birth (babies being born before 34 weeks pregnancy) occurs in approximately 11% of pregnancies; preterm birth can lead to complications for the baby.
When mothers are identified as being at risk of going into preterm birth (giving birth within the next 14 days) there are several treatments available that may help reduce the likelihood of complications for the baby. These treatments usually need to be started within 24 hours so it is very important that diagnosing preterm labour in not only fast but accurate.
There are several methods commonly used within hospitals for diagnosing mothers who may be at risk of going into preterm labour. The two most common ones are foetal fibronectin (fFN) and phosphorylated insulin-like growth factor binding protein 1 (phIGFBP-1).
The purpose of this study is to compare the two tests to see which is more accurate at predicting preterm birth.
This is a prospective comparative study of fFN (control) and PhIGFBP-1 test (comparator) for women with singleton pregnancies between 22-34 weeks gestation presenting with self-reported signs, symptoms or complaints suggestive of preterm labour.
Both tests will be done on every participant - the tests will be sequenced so that every 5 participants the fFN test is undertaken first and then the next cohort of 5 will have the PhIGFBP-1 swab taken first. This is to remove any potential biases surrounding which test was undertaken first. Data collection (case report forms (CRFs)) will clearly document which test was performed 1st and 2nd.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with singleton pregnancy between 22-34 weeks gestation with signs and symptoms of pre term birth
Key inclusion criteria (7 listed)
- aged ≥ 18 years
- confirmed pregnancy
- gestational age between 22 and 34 weeks
- self-reported signs, symptoms or complaints suggestive of preterm labour;
Key exclusion criteria (11 listed)
- unable to provide written informed consent
- multiple pregnancy
- participating in an interventional clinical trial
- a symptom not associated with idiopathic threatened preterm delivery (e.g. trauma)
- contraindicated to either fFN or PhIGFBP-1; e.g.
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
diagnosis of heightened risk of imminent delivery
Time frame: 7 days
preterm birth at 7 days
diagnosis of heightened risk of imminent delivery
Time frame: 14 days
preterm birth at 14 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- 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.
Amaju Ikomi, MBBS FRCOG study director
Basildon and Thurrock University Hospitals NHS FT
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 Pre Term Birth, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
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 11 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: stopped early, as of the sponsor's last update on 12 Jan 2024. 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 United Kingdom. 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 was stopped early. Results are not available in the source record.
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?
diagnosis of heightened risk of imminent delivery (time frame: 7 days). The study lists 2 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 12 Jan 2024.