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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • AinshamsU

    Cairo, 123456

Other trials in Egypt

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 .

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted24 Apr 2019
  2. Study start26 Apr 2019
  3. Primary completion30 Jul 2019
  4. Study completion15 Aug 2019

Resources

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)
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

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.

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