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

NCT03703037 | Completed DMC

• 1 other identifier: GI17-00009
• Study Type: observational
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abnormality in Fetal Heart Rate or Rhythm; Ultrasound; Late Pregnancy

Keywords

Late term pregnancy; Doppler

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Middle cerebral artery pulsatility index

  24 hours before delivery

• Mean uterine artery pulsatility index

  24 hours before delivery

• Middle cerebral artery pulsatility index to mean uterine artery pulsatility index ratio

  24 hours before delivery

• Oligohydramnios

  24 hours before delivery

Study Arms (3)

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

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

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

Interventions

Ultrasound and Doppler ultrasound DIAGNOSTIC_TEST

Assessment of fetal cerebral and maternal uterine pulsatility index using Doppler ultrasound. Measurement of amniotic fluid index according to four-quadrant technique.

Also known as: Pulsatility index, Amniotic fluid index

Cases; Cohort; Controls

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (5)

• 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.

  PMID: 28738721 BACKGROUND

• 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.

  PMID: 16097973 BACKGROUND

• 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.

  PMID: 8142046 BACKGROUND

• 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.

  PMID: 8096472 BACKGROUND

• 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.

  PMID: 25763408 BACKGROUND

MeSH Terms

Interventions

Ultrasonography, Doppler

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Flavio Hernández-Castro, MD PhD

  Hospital Universitario Dr. José Eleuterio González UANL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator Flavio Hernández Castro MD PhD

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 11, 2018
• Study Start: January 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Locations

ME (1)