Time to Delivery of Preterm Birth
2 other identifiers
observational
128
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJanuary 12, 2024
January 1, 2024
7.4 years
July 27, 2016
January 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
diagnosis of heightened risk of imminent delivery
preterm birth at 7 days
7 days
diagnosis of heightened risk of imminent delivery
preterm birth at 14 days
14 days
Eligibility Criteria
Pregnant women with singleton pregnancy between 22-34 weeks gestation with signs and symptoms of pre term birth
You may qualify if:
- 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
You may not qualify if:
- 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
- cervical dilation ≥3cm dilated
- evidence of rupture of membranes
- had intercourse in last 24 hours
- cervical cerclage in situ
- placenta praevia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Basildon Hospital
Basildon, Essex, SS16 5NL, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Amaju Ikomi, MBBS FRCOG
Basildon and Thurrock University Hospitals NHS FT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2016
First Posted
August 3, 2016
Study Start
August 1, 2016
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
January 12, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share