Clinical trial NCT03703037: Uterine, Fetal Cerebral Doppler and Oligohydramnios to Predict Abnormal Heart Rate Tracings in Postterm Pregnancies
Official title: Clinical Utility of Uterine, Fetal Cerebral Doppler and Oligohydramnios to Predict Abnormal Heart Rate Tracings in Pregnancies at or Beyond 41 Weeks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abnormality in Fetal Heart Rate or Rhythm
Ultrasound
Late Pregnancy
Keywords: Late term pregnancy
Doppler
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 227
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Category III fetal heart rate tracings
timeFrame: 24 hours
Secondary outcomes:
measure: Middle cerebral artery pulsatility index
timeFrame: 24 hours before delivery
measure: Mean uterine artery pulsatility index
timeFrame: 24 hours before delivery
measure: Middle cerebral artery pulsatility index to mean uterine artery pulsatility index ratio
timeFrame: 24 hours before delivery
measure: Oligohydramnios
timeFrame: 24 hours before delivery
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. José Eleuterio González
state: Nuevo León
Study officials:
affiliation: Hospital Universitario Dr. José Eleuterio González UANL
name: Flavio Hernández-Castro, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.