Fetal Head Circumference as a Predictor of Operative Delivery

• Conditions: Pregnancy

• Registration Number: NCT02739503
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-15
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-06
• Last Update Posted: 2017-01-10
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of "operative delivery" including instrumental deliveries or cesarean sections.	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center; 🇮🇱 Hadera, Israel