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PregnancyNCT02739503

Fetal Head Circumference as a Predictor of Operative Delivery

An observational study of Pregnancy, run by Hillel Yaffe Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study set out to investigate whether antenatal ultrasound evaluation of the Fetal Head Circumference (FHC) could potentially possess a predictive role in determining women at increased risk for operative delivery or cesarean section. 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
Pregnancy
What is being tested?
Ultrasound
Type of treatment
Medical device
How many people
500 participants
Where
1 siteIsrael
Study dates
Apr 2016to Jun 2017
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: Women at term (37+0 - 42+0 weeks' gestation)

Who may be able to join

  • Women at term (37+0 - 42+0 weeks' gestation)
  • Singleton pregnancies
  • Cephalic presentation
  • Anticipated vaginal delivery

Who cannot join

  • Younger than 18 years old and older than 45 years old
  • Women who incapable of providing informed consent

Trial locations and contacts

1 site in 1 country.

Ofer Limonad, M.D contact

oferlimonad@gmail.com

Alon Shrim, M.D contact

alon.shrim@gmail.com

Israel1 site, 1 recruiting

  • Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center

    Hadera, 38100

    Ofer Limonad, M.D, 00-972-52-5322972, oferlimonad@gmail.com

    Ofer Limonad, M.D

    Recruiting

Other trials in Israel

About this study

This study set out to investigate whether antenatal ultrasound evaluation of the Fetal Head Circumference (FHC) could potentially possess a predictive role in determining women at increased risk for operative delivery or cesarean section.

Read the detailed description

When vaginal delivery poses a danger to the mother or newborn infant, operative delivery (instrumental or cesarean section) is indicated. Some specific indications for operative delivery include prolonged second-stage of labor, suspected compromise of the fetus, health-related disorders of the fetus or the mother that justify shortening of the second-stage of active labor and more. In cases where cephalo-pelvic disproportion (CPD) is suspected or when instrumental delivery is not possible or fails, cesarean section plays a critical role . Studies trying to identify women at greatest risk of CPD have concluded that neither x ray, nor computed tomography or magnetic resonance imaging have a proven value in labor management or in predicting clinical outcomes . Previous studies assessing fetal factors that are associated with operative delivery have focused mainly on estimated fetal weight to predict macrosomia. Nonetheless, ultrasound estimation of the fetal weight was shown to differ by as much as 20% from actual birth weight, and identifying cases with suspected fetal macrosomia, other than for diabetic pregnancies, was not found to improve labor outcome . As weeks may possibly elapse between the time of last antenatal assessment and onset of labor, a further challenge is related to the timing of ultrasound assessment. Several studies have shown an association between increased Fetal Head Circumference (FHC) and prolonged second-stage of labor, instrumental delivery and cesarean section . However, FHC can only be acquired following delivery and has no predictive value for interventions in labor.

Conditions
Pregnancy
Being tested
Ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltrasoundDevice

    Patients will receive ultrasound in the ultrasound unit at Hillel Yaffe Medical Center within 10 days before onset of induced or spontaneous labors. The ultrasound team has been trained in FHC , Estimated Fetal Weight (EFW) and Biparietal Diameter (BPD) measurement .Optimal ultrasound measurements of FHC and BPD will be obtained. The average of 3 fetal head circumference measurements will be recorded. Investigators consider the FHC and BPD to be optimal when a clear outline of the entire fetal skull is measured, and the landmarks (the thalamus, cavum septum pellucidum and choroid plexus in the atrium of the lateral ventricles) are visualized. Subsequent information of labor outcome as well as normal head circumference ,post-delivery will be obtained from maternal and neonatal medical records.

What is being measured

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

  1. The rate of "operative delivery" including instrumental deliveries or cesarean sections.

    Measured: 1 year

Secondary outcomes (5)

  1. Length (in hours) of the first and second stages of labor.

    Measured: 1 year

  2. Rate of obstetric anal sphincter injury.

    Measured: 1 year

  3. Rate of early postpartum hemorrhage (PPH).

    Measured: 1 year

  4. Rate of neonatal trauma.

    Measured: 1 year

  5. Rate of admission to the neonatal intensive care unit.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionJun 2017 (estimated)
  4. Study completionJun 2017 (estimated)

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
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02739503
Sponsor's protocol ID
0017-16-HYMC
Status last verified
Jan 2017
First submitted
7 Apr 2016
Last updated
10 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • ACOG Practice Bulletin No. 154: Operative Vaginal Delivery. Obstet Gynecol. 2015 Nov;126(5):e56-e65. doi: 10.1097/AOG.0000000000001147. No abstract available.

    PubMed 26488523

  • Murphy DJ, Liebling RE, Verity L, Swingler R, Patel R. Early maternal and neonatal morbidity associated with operative delivery in second stage of labour: a cohort study. Lancet. 2001 Oct 13;358(9289):1203-7. doi: 10.1016/S0140-6736(01)06341-3.

    PubMed 11675055

  • Maharaj D. Assessing cephalopelvic disproportion: back to the basics. Obstet Gynecol Surv. 2010 Jun;65(6):387-95. doi: 10.1097/OGX.0b013e3181ecdf0c.

    PubMed 20633305

  • Lenhard MS, Johnson TR, Weckbach S, Nikolaou K, Friese K, Hasbargen U. Pelvimetry revisited: analyzing cephalopelvic disproportion. Eur J Radiol. 2010 Jun;74(3):e107-11. doi: 10.1016/j.ejrad.2009.04.042. Epub 2009 May 13.

    PubMed 19443160

  • Peregrine E, O'Brien P, Jauniaux E. Clinical and ultrasound estimation of birth weight prior to induction of labor at term. Ultrasound Obstet Gynecol. 2007 Mar;29(3):304-9. doi: 10.1002/uog.3949.

    PubMed 17290365

  • Irion O, Boulvain M. Induction of labour for suspected fetal macrosomia. Cochrane Database Syst Rev. 2000;(2):CD000938. doi: 10.1002/14651858.CD000938.

    PubMed 10796221

  • Elvander C, Hogberg U, Ekeus C. The influence of fetal head circumference on labor outcome: a population-based register study. Acta Obstet Gynecol Scand. 2012 Apr;91(4):470-5. doi: 10.1111/j.1600-0412.2012.01358.x. Epub 2012 Feb 28.

    PubMed 22229662

  • Mujugira A, Osoti A, Deya R, Hawes SE, Phipps AI. Fetal head circumference, operative delivery, and fetal outcomes: a multi-ethnic population-based cohort study. BMC Pregnancy Childbirth. 2013 May 7;13:106. doi: 10.1186/1471-2393-13-106.

    PubMed 23651454

  • Verburg BO, Steegers EA, De Ridder M, Snijders RJ, Smith E, Hofman A, Moll HA, Jaddoe VW, Witteman JC. New charts for ultrasound dating of pregnancy and assessment of fetal growth: longitudinal data from a population-based cohort study. Ultrasound Obstet Gynecol. 2008 Apr;31(4):388-96. doi: 10.1002/uog.5225.

    PubMed 18348183

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy, run by Hillel Yaffe Medical Center at 1 site in Israel.

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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Jan 2017. 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 Israel. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ofer Limonad, M.D (oferlimonad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of "operative delivery" including instrumental deliveries or cesarean sections. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02739503, which also lists 9 linked publications.

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 10 Jan 2017.

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