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Completed

NCT Number: NCT03703037

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

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

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, 64460, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Pulsatility index, Amniotic fluid index

Primary outcomes

  1. Category III fetal heart rate tracings

    Time frame: 24 hours

    Absent baseline fetal heart rate variability and any of the following: recurrent late decelerations, recurrent variable decelerations, bradycardia, sinusoidal pattern

Secondary outcomes

  1. Middle cerebral artery pulsatility index

    Time frame: 24 hours before delivery

    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

  2. Mean uterine artery pulsatility index

    Time frame: 24 hours before delivery

    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.

  3. Middle cerebral artery pulsatility index to mean uterine artery pulsatility index ratio

    Time frame: 24 hours before delivery

    The ratio between the pulsatility index of the middle cerebral artery and the mean pulsatility index value of both uterine arteries.

  4. Oligohydramnios

    Time frame: 24 hours before delivery

    Amniotic fluid index (Assessed acording to four-quadrant technique)

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 11, 2018
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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