Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03703037
Enrollment
227
Registered
2018-10-11
Start date
2016-01-01
Completion date
2019-10-01
Last updated
2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Late term pregnancy, Doppler

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

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.

Interventions

DIAGNOSTIC_TESTUltrasound 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.

Sponsors

Hospital Universitario Dr. Jose E. Gonzalez
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Category III fetal heart rate tracings24 hoursAbsent baseline fetal heart rate variability and any of the following: recurrent late decelerations, recurrent variable decelerations, bradycardia, sinusoidal pattern

Secondary

MeasureTime frameDescription
Middle cerebral artery pulsatility index24 hours before deliveryThe 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
Mean uterine artery pulsatility index24 hours before deliveryThe 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.
Middle cerebral artery pulsatility index to mean uterine artery pulsatility index ratio24 hours before deliveryThe ratio between the pulsatility index of the middle cerebral artery and the mean pulsatility index value of both uterine arteries.
Oligohydramnios24 hours before deliveryAmniotic fluid index (Assessed acording to four-quadrant technique)

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026