Uterine, Fetal Cerebral Doppler and Oligohydramnios to Predict Abnormal Heart Rate Tracings in Postterm Pregnancies

Clinical Utility of Uterine, Fetal Cerebral Doppler and Oligohydramnios to Predict Abnormal Heart Rate Tracings in Pregnancies at or Beyond 41 Weeks

Objective: To estimate the value of uterine, fetal cerebral Doppler and oligohydramnios to predict abnormal fetal heart rate tracings in pregnancies at or beyond 41 weeks

Study Overview

• Status: Completed
• Conditions: Ultrasound; Late Pregnancy; Abnormality in Fetal Heart Rate or Rhythm
• Intervention / Treatment: Diagnostic test: Ultrasound and Doppler ultrasound

Detailed Description

This will be a nested case-control study that was conducted at University Hospital Dr. Jose E. Gonzalez after the approval of Institutional ethical committee. Women with low risk late term or postterm pregnancy (at least 41 weeks) with confirm gestational age who will be referred to our Maternal-fetal unit and admitted 1 to 2 days prior to induction of labour according institutional protocol will be recruited and constitute the cohort.

Cases will be patients with abnormal intrapartum cardiotocogram (category III fetal heart rate tracing). For each case, four controls will be matched. The primary outcome will be to obtain odds ratios for the Doppler parameters (middle cerebral artery pulsatility index, mean uterine artery pulsatility index and Middle cerebral artery pulsatility index to mean uterine artery pulsatility index ratio) and amniotic fluid index that would be associated with intrapartum category III fetal heart rate tracing.

• Study Type: Observational
• Enrollment (Actual): 227

Contacts and Locations

Study Locations

• Mexico
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Hospital Universitario Dr. Jose Eleuterio Gonzalez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women with low risk late term or postterm pregnancy (at least 41 weeks) with confirm gestational age by first trimester ultrasound examination, who will be referred to our Maternal-fetal unit and admitted 1 to 2 days prior to induction of labour according institutional protocol.

Description

Inclusion Criteria:

• Singleton pregnancy
• Gestational age of at least 287 days (41 weeks)
• Low risk pregnancy (defined as the absence of maternal or fetal complications other than postterm pregnancy)

Exclusion Criteria:

• Twin or multiple gestation
• Uncertain gestational age
• Non vertex presentation
• Estimated fetal weight below the 10th percentile for gestational age (Hadlock´s formula)
• Fetal macrosomia (estimated fetal weight ≥ 4 Kilos) diagnosed by clinical measurement (Johnson´s technique) or ultrasound measurement (Hadlock´s formula).
• Fetal abnormalities found on routine anomaly scan.
• Maternal medical disorder (preeclampsia, chronic hypertension, diabetes, lupus, hyperthyroidism)
• Prelabour rupture of membranes
• Antepartum hemorrhage
• Any fetopelvic disproportion that could create dystocia during labor.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort; This will be a nested case-control study. Women with low risk pregnancies at or beyond 41 weeks, who will be referred to our Maternal-fetal unit and admitted 1 to 2 days prior to induction of labour according institutional protocol will constitute the cohort. Then women with intrapartum abnormal fetal heart rate tracings (cases) will be identified and match with controls. The primary outcome will be to obtain odds ratios for the Doppler ultrasound parameters (middle cerebral artery pulsatility index, mean uterine artery pulsatility index and Middle cerebral artery pulsatility index to mean uterine artery pulsatility index ratio) and Ultrasound assessment of amniotic fluid index that would be associated with intrapartum category III fetal heart rate tracing.	Diagnostic test: Ultrasound and Doppler ultrasound; Assessment of fetal cerebral and maternal uterine pulsatility index using Doppler ultrasound. Measurement of amniotic fluid index according to four-quadrant technique.; Other Names: Pulsatility index; Amniotic fluid index
Cases; Cases will be patients with abnormal intrapartum cardiotocogram (category III fetal heart rate tracing). Intervention: Ultrasound and Doppler ultrasound	Diagnostic test: Ultrasound and Doppler ultrasound; Assessment of fetal cerebral and maternal uterine pulsatility index using Doppler ultrasound. Measurement of amniotic fluid index according to four-quadrant technique.; Other Names: Pulsatility index; Amniotic fluid index
Controls; Those will be patients with normal intrapartum cardiotocogram (category I fetal heart rate tracing) or category II that converted into category I after intrauterine resuscitation methods. Intervention: Ultrasound and Doppler ultrasound	Diagnostic test: Ultrasound and Doppler ultrasound; Assessment of fetal cerebral and maternal uterine pulsatility index using Doppler ultrasound. Measurement of amniotic fluid index according to four-quadrant technique.; Other Names: Pulsatility index; Amniotic fluid index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Category III fetal heart rate tracings	Absent baseline fetal heart rate variability and any of the following: recurrent late decelerations, recurrent variable decelerations, bradycardia, sinusoidal pattern	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Middle cerebral artery pulsatility index	The middle cerebral artery pulsatility index will be obtained in a transversal view of the fetal head, at the level of its origin from the circle of Willis. Measurements will be obtained during periods of fetal apnea, and the angle of insonation will be maintained as close to 0° as possible when interrogating the middle cerebral artery	24 hours before delivery
Mean uterine artery pulsatility index	The probe will be placed on the lower quadrant of the abdomen, angled medially, and again color Doppler imaging will be used to identify the uterine artery at the apparent crossover with the external iliac artery. Measurements will be taken approximately 1 cm distal to the crossover point. In all cases, once it had been ensured that the angle was less than 20◦, the pulsed Doppler gate will be placed over the whole width of the vessel. Angle correction was then applied and the signal updated until three to five similar consecutive waveforms had been obtained. Mean pulsatility index will be calculated as the average pulsatility index of right and left arteries.	24 hours before delivery
Middle cerebral artery pulsatility index to mean uterine artery pulsatility index ratio	The ratio between the pulsatility index of the middle cerebral artery and the mean pulsatility index value of both uterine arteries.	24 hours before delivery
Oligohydramnios	Amniotic fluid index (Assessed acording to four-quadrant technique)	24 hours before delivery

Collaborators and Investigators

• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Investigators: Principal Investigator: Flavio Hernández-Castro, MD PhD, Hospital Universitario Dr. Jose Eleuterio Gonzalez UANL

Publications and helpful links

General Publications

• Lebovitz O, Barzilay E, Mazaki-Tovi S, Gat I, Achiron R, Gilboa Y. The clinical value of maternal and fetal Doppler parameters in low-risk postdates pregnancies - a prospective study. J Matern Fetal Neonatal Med. 2018 Nov;31(21):2893-2897. doi: 10.1080/14767058.2017.1359531. Epub 2017 Aug 9.
• Lam H, Leung WC, Lee CP, Lao TT. The use of fetal Doppler cerebroplacental blood flow and amniotic fluid volume measurement in the surveillance of postdated pregnancies. Acta Obstet Gynecol Scand. 2005 Sep;84(9):844-8. doi: 10.1111/j.0001-6349.2005.00741.x.
• Arabin B, Becker R, Mohnhaupt A, Vollert W, Weitzel HK. Prediction of fetal distress and poor outcome in prolonged pregnancy using Doppler ultrasound and fetal heart rate monitoring combined with stress tests (II). Fetal Diagn Ther. 1994 Jan-Feb;9(1):1-6. doi: 10.1159/000263899.
• Tongsong T, Srisomboon J. Amniotic fluid volume as a predictor of fetal distress in postterm pregnancy. Int J Gynaecol Obstet. 1993 Mar;40(3):213-7. doi: 10.1016/0020-7292(93)90833-i.
• Adiga P, Kantharaja I, Hebbar S, Rai L, Guruvare S, Mundkur A. Predictive value of middle cerebral artery to uterine artery pulsatility index ratio in hypertensive disorders of pregnancy. Int J Reprod Med. 2015;2015:614747. doi: 10.1155/2015/614747. Epub 2015 Feb 1.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): February 1, 2019
• Study Completion (ACTUAL): October 1, 2019

Study Registration Dates

• First Submitted: October 9, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (ACTUAL): October 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 27, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Doppler; Late term pregnancy
• Additional Relevant MeSH Terms: Pregnancy Complications; Oligohydramnios
• Other Study ID Numbers: GI17-00009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No