Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fetal Head Circumference as a Predictor of Operative Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02739503
Recruitment Status : Unknown
Verified January 2017 by Hillel Yaffe Medical Center.
Recruitment status was:  Recruiting
First Posted : April 15, 2016
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

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.

Condition or disease Intervention/treatment
Pregnancy Device: Ultrasound

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fetal Head Circumference as a Predictor of Operative Delivery
Study Start Date : April 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Intervention Details:
  • Device: Ultrasound
    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.


Primary Outcome Measures :
  1. The rate of "operative delivery" including instrumental deliveries or cesarean sections. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Length (in hours) of the first and second stages of labor. [ Time Frame: 1 year ]
  2. Rate of obstetric anal sphincter injury. [ Time Frame: 1 year ]
  3. Rate of early postpartum hemorrhage (PPH). [ Time Frame: 1 year ]
  4. Rate of neonatal trauma. [ Time Frame: 1 year ]
  5. Rate of admission to the neonatal intensive care unit. [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women at term (37+0 - 42+0 weeks' gestation)
Criteria

Inclusion Criteria:

  1. Women at term (37+0 - 42+0 weeks' gestation)
  2. Singleton pregnancies
  3. Cephalic presentation
  4. Anticipated vaginal delivery

Exclusion Criteria:

  1. Younger than 18 years old and older than 45 years old
  2. Women who incapable of providing informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739503


Contacts
Layout table for location contacts
Contact: Ofer Limonad, M.D oferlimonad@gmail.com
Contact: Alon Shrim, M.D alon.shrim@gmail.com

Locations
Layout table for location information
Israel
Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center Recruiting
Hadera, Israel, 38100
Contact: Ofer Limonad, M.D    00-972-52-5322972    oferlimonad@gmail.com   
Principal Investigator: Ofer Limonad, M.D         
Principal Investigator: Alon Scrim, M.D         
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Ofer Limonad, M.D Hillel Yaffe Medical Center

Publications:

Layout table for additonal information
Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT02739503     History of Changes
Other Study ID Numbers: 0017-16-HYMC
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No