Fetal Fibronectin (Ffn)NCT03925922
Comparison Between Fetal Fibronectin (Ffn) vs Cervical Length in Patient With Unfavourable Cervix in Prediction of Successful Induction of Labor
An observational study of Fetal Fibronectin (Ffn), run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to assess the efficacy of fFN compared to transvaginal ultrasound of cervix in prediction of successful induction of labor for unfavorable cervix (bishop score 5 or less). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Fibronectin (Ffn)
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Apr 2019to 15 Aug 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
- Healthy volunteers accepted
- Adult
Study population: patient will be recruited in this study from those attending to obstetric ER of Ainshams OB/GYN hospital who are nullipara pregnant women gestational age between 37-42 weeks
Who may be able to join
- Nulliparous singleton pregnancy
- gestational age between 37week and 42 weeks
- Cephalic presentation
- Bishop score of 5 or less
- No clinical evidence of regular contraction
Who cannot join
- Rupture of membrane
- Vaginal bleeding
- Any contraindication to vaginal delivery
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the efficacy of fFN compared to transvaginal ultrasound of cervix in prediction of successful induction of labor for unfavorable cervix (bishop score 5 or less).
Read the detailed description
Induction of labor should be undertaken when the benefits of delivery to either mother or fetus outweigh the risks of pregnancy continuation. Many accepted medical and obstetric indications for labor induction like Hypertensive disorders, Preeclampsia/ eclampsia, Gestational hypertension, Maternal medical conditions, Diabetes mellitus, Renal disease, Chronic pulmonary disease, Chorioamnionitis and Oligohydramnios .Sonographic assessment of cervical length for predicting the outcome of labor induction has been evaluated in numerous studies. The role of ultrasound examination as a tool for selecting women likely to have a successful induction is uncertain . transvaginal sonographic measurements of cervical length in nulliparous women independently predict the likelihood of progress in nulliparous women undergoing labor induction. These observations strongly support the notion that in nulliparous women undergoing labor induction preinduction cervical length plays a key role in labor progression during the latent phase, but not during the active phase of labor .Entering the active phase within 24 hr of induction. On the other hand, cervical length appears to poorly predict the likelihood of cesarean delivery for failure to Bishop's score has the advantage of being universally known . The cutoff point at which delivery can be induced without increasing the risk of cesarean delivery is generally 7 or 6, but this varies from one country to another depending on different local guidelines 6 7 8. However, that point is rarely reached in reality. What's more, Bishop's score does not include parity, even though this variable is known for being closely associated with the induction success. Last, several authors have shown that some components of Bishop's score have a low prognostic value for the success or the failure of the induction .The Bishop score is a poor predictor for the outcome of induced labor at term and should not be used to decide whether to induce labor or not .Fibronectin is large glycoprotein (molecular mass about 420kDa) is normally present in essentially all tissues and body fluids. Its primary function is its role in cell adhesion and phagocytosis .Fetal fibronectin, a glycoprotein thought to act as an adherent at the maternal fetal interface, is uncommonly present in cervicovaginal secretions in the late second and early third trimesters. Although the risk for preterm birth increases as the level of fetal fibronectin rises, it has been evaluated only as a qualitative test, with a value of 50ng/dL or greater being called positive. A positive test is believed to indicate disruption of the maternal-fetal decidual attachment. Asymptomatic women with a positive fetal fibronectin test have an increased risk for preterm birth before 35 weeks, especially within 2 weeks of a positive result. Although the sensitivity of the fibronectin test at 22 to 24 weeks for all spontaneous births before 35 weeks was only 25%, sensitivity for births before 28 weeks was 65% in one study .fFN has been proposed as a new tool for cervical evaluation before labor induction. fFN in cervicovaginal secretion of term deliveries yield a high probability of success of induction women with fibronective negative cervicovaginal secretion and unfavorable cervix score induction of labour should not be attempted .
- Conditions
- Fetal Fibronectin (Ffn)
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of fetal fibronectin in prediction of successful induction of labour
Comparison between fetal fibronectin versus transvaginal sonography in prediction of successful induction of labour of unfavorable cervix
Measured: 24 hours of induction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start26 Apr 2019
- Primary completion30 Jul 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Fibronectin (Ffn)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hytham elhamy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925922
- Sponsor's protocol ID
- Ffn and induction of labour
- Status last verified
- Aug 2019
- First submitted
- 22 Apr 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Fetal Fibronectin (Ffn) vs Cervical Length in Patient With Unfavourable Cervix in Prediction of Successful Induction of Labor
- ClinicalTrials.gov ID
- NCT03925922
- Acronym / sponsor ID
- Ffn and induction of labour
- Conditions
- Fetal Fibronectin (Ffn)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 24 Apr 2019 (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 aims to assess the efficacy of fFN compared to transvaginal ultrasound of cervix in prediction of successful induction of labor for unfavorable cervix (bishop score 5 or less).
Detailed description
Induction of labor should be undertaken when the benefits of delivery to either mother or fetus outweigh the risks of pregnancy continuation. Many accepted medical and obstetric indications for labor induction like Hypertensive disorders, Preeclampsia/ eclampsia, Gestational hypertension, Maternal medical conditions, Diabetes mellitus, Renal disease, Chronic pulmonary disease, Chorioamnionitis and Oligohydramnios .Sonographic assessment of cervical length for predicting the outcome of labor induction has been evaluated in numerous studies. The role of ultrasound examination as a tool for selecting women likely to have a successful induction is uncertain . transvaginal sonographic measurements of cervical length in nulliparous women independently predict the likelihood of progress in nulliparous women undergoing labor induction. These observations strongly support the notion that in nulliparous women undergoing labor induction preinduction cervical length plays a key role in labor progression during the latent phase, but not during the active phase of labor .Entering the active phase within 24 hr of induction. On the other hand, cervical length appears to poorly predict the likelihood of cesarean delivery for failure to Bishop's score has the advantage of being universally known . The cutoff point at which delivery can be induced without increasing the risk of cesarean delivery is generally 7 or 6, but this varies from one country to another depending on different local guidelines 6 7 8. However, that point is rarely reached in reality. What's more, Bishop's score does not include parity, even though this variable is known for being closely associated with the induction success. Last, several authors have shown that some components of Bishop's score have a low prognostic value for the success or the failure of the induction .The Bishop score is a poor predictor for the outcome of induced labor at term and should not be used to decide whether to induce labor or not .Fibronectin is large glycoprotein (molecular mass about 420kDa) is normally present in essentially all tissues and body fluids. Its primary function is its role in cell adhesion and phagocytosis .Fetal fibronectin, a glycoprotein thought to act as an adherent at the maternal fetal interface, is uncommonly present in cervicovaginal secretions in the late second and early third trimesters. Although the risk for preterm birth increases as the level of fetal fibronectin rises, it has been evaluated only as a qualitative test, with a value of 50ng/dL or greater being called positive. A positive test is believed to indicate disruption of the maternal-fetal decidual attachment. Asymptomatic women with a positive fetal fibronectin test have an increased risk for preterm birth before 35 weeks, especially within 2 weeks of a positive result. Although the sensitivity of the fibronectin test at 22 to 24 weeks for all spontaneous births before 35 weeks was only 25%, sensitivity for births before 28 weeks was 65% in one study .fFN has been proposed as a new tool for cervical evaluation before labor induction. fFN in cervicovaginal secretion of term deliveries yield a high probability of success of induction women with fibronective negative cervicovaginal secretion and unfavorable cervix score induction of labour should not be attempted .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patient will be recruited in this study from those attending to obstetric ER of Ainshams OB/GYN hospital who are nullipara pregnant women gestational age between 37-42 weeks
Key inclusion criteria (5 listed)
- Nulliparous singleton pregnancy
- gestational age between 37week and 42 weeks
- Cephalic presentation
- Bishop score of 5 or less
- No clinical evidence of regular contraction
Key exclusion criteria (3 listed)
- Rupture of membrane
- Vaginal bleeding
- Any contraindication to vaginal delivery
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
Efficacy of fetal fibronectin in prediction of successful induction of labour
Time frame: 24 hours of induction.
Comparison between fetal fibronectin versus transvaginal sonography in prediction of successful induction of labour of unfavorable cervix
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 28 Aug 2019.
- Individual participant dataSharing planned: Yes
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.
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 Fetal Fibronectin (Ffn), run by Ain Shams University at 1 site in Egypt.
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 5 inclusion and 3 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 28 Aug 2019. 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 Egypt. 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?
Efficacy of fetal fibronectin in prediction of successful induction of labour (time frame: 24 hours of induction.). 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 28 Aug 2019.