Fetal Head Circumference as a Predictor of Operative Delivery
1 other identifier
observational
500
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 7, 2016
CompletedFirst Posted
Study publicly available on registry
April 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJanuary 10, 2017
January 1, 2017
1.2 years
April 7, 2016
January 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The rate of "operative delivery" including instrumental deliveries or cesarean sections.
1 year
Secondary Outcomes (5)
Length (in hours) of the first and second stages of labor.
1 year
Rate of obstetric anal sphincter injury.
1 year
Rate of early postpartum hemorrhage (PPH).
1 year
Rate of neonatal trauma.
1 year
Rate of admission to the neonatal intensive care unit.
1 year
Interventions
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.
Eligibility Criteria
Women at term (37+0 - 42+0 weeks' gestation)
You may qualify if:
- Women at term (37+0 - 42+0 weeks' gestation)
- Singleton pregnancies
- Cephalic presentation
- Anticipated vaginal delivery
You may not qualify if:
- Younger than 18 years old and older than 45 years old
- Women who incapable of providing informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center
Hadera, 38100, Israel
Related Publications (9)
ACOG Practice Bulletin No. 154: Operative Vaginal Delivery. Obstet Gynecol. 2015 Nov;126(5):e56-e65. doi: 10.1097/AOG.0000000000001147. No abstract available.
PMID: 26488523BACKGROUNDMurphy 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.
PMID: 11675055BACKGROUNDMaharaj D. Assessing cephalopelvic disproportion: back to the basics. Obstet Gynecol Surv. 2010 Jun;65(6):387-95. doi: 10.1097/OGX.0b013e3181ecdf0c.
PMID: 20633305BACKGROUNDLenhard 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.
PMID: 19443160BACKGROUNDPeregrine 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.
PMID: 17290365BACKGROUNDIrion O, Boulvain M. Induction of labour for suspected fetal macrosomia. Cochrane Database Syst Rev. 2000;(2):CD000938. doi: 10.1002/14651858.CD000938.
PMID: 10796221BACKGROUNDElvander 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.
PMID: 22229662BACKGROUNDMujugira 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.
PMID: 23651454BACKGROUNDVerburg 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.
PMID: 18348183BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ofer Limonad, M.D
Hillel Yaffe Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2016
First Posted
April 15, 2016
Study Start
April 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
January 10, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share