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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03703037
Recruitment Status : Completed
First Posted : October 11, 2018
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez

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

Condition or disease Intervention/treatment
Abnormality in Fetal Heart Rate or Rhythm Ultrasound Late Pregnancy 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.

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Study Type : Observational
Actual Enrollment : 227 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Clinical Utility of Uterine, Fetal Cerebral Doppler and Oligohydramnios to Predict Abnormal Heart Rate Tracings in Pregnancies at or Beyond 41 Weeks
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : October 1, 2019

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703037


Locations
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Mexico
Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
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Principal Investigator: Flavio Hernández-Castro, MD PhD Hospital Universitario Dr. José Eleuterio González UANL

Publications:
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Responsible Party: Flavio Hernández Castro, Principal investigator Flavio Hernández Castro MD PhD, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT03703037    
Other Study ID Numbers: GI17-00009
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez:
Late term pregnancy
Doppler
Additional relevant MeSH terms:
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Oligohydramnios
Pregnancy Complications