Abnormality in Fetal Heart Rate or RhythmNCT03703037
Uterine, Fetal Cerebral Doppler and Oligohydramnios to Predict Abnormal Heart Rate Tracings in Postterm Pregnancies
An observational study of Abnormality in Fetal Heart Rate or Rhythm and Ultrasound, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial 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 Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abnormality in Fetal Heart Rate or Rhythm, Ultrasound, Late Pregnancy
- What is being tested?
- Ultrasound and Doppler ultrasound
- How many people
- 227 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2016to 1 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
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- Maternal medical disorder (preeclampsia, chronic hypertension, diabetes, lupus, hyperthyroidism)
- Prelabour rupture of membranes
- Antepartum hemorrhage
- Any fetopelvic disproportion that could create dystocia during labor.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, 64460
About this study
Official title: Clinical Utility of Uterine, Fetal Cerebral Doppler and Oligohydramnios to Predict Abnormal Heart Rate Tracings in Pregnancies at or Beyond 41 Weeks
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
Read the 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.
- Being tested
- Ultrasound and Doppler ultrasound
- Keywords
- Late term pregnancy, Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound and Doppler ultrasoundDiagnostic test
Also called Pulsatility index, Amniotic fluid index
Assessment of fetal cerebral and maternal uterine pulsatility index using Doppler ultrasound. Measurement of amniotic fluid index according to four-quadrant technique.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: Diagnostic Test: Ultrasound and Doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (4)
Middle cerebral artery pulsatility index
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
Measured: 24 hours before delivery
Mean uterine artery pulsatility index
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.
Measured: 24 hours before delivery
Middle cerebral artery pulsatility index to mean uterine artery pulsatility index ratio
The ratio between the pulsatility index of the middle cerebral artery and the mean pulsatility index value of both uterine arteries.
Measured: 24 hours before delivery
Oligohydramnios
Amniotic fluid index (Assessed acording to four-quadrant technique)
Measured: 24 hours before delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start1 Jan 2016
- Primary completion1 Feb 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Abnormality in Fetal Heart Rate or RhythmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Flavio Hernández-Castro, MD PhD, Principal investigator, Hospital Universitario Dr. José Eleuterio González UANL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703037
- Sponsor's protocol ID
- GI17-00009
- Status last verified
- Oct 2019
- First submitted
- 9 Oct 2018
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28738721Lam 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.
PubMed 16097973Arabin 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.
PubMed 8142046Tongsong 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.
PubMed 8096472Adiga 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.
PubMed 25763408
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Uterine, Fetal Cerebral Doppler and Oligohydramnios to Predict Abnormal Heart Rate Tracings in Pregnancies at or Beyond 41 Weeks
- ClinicalTrials.gov ID
- NCT03703037
- Acronym / sponsor ID
- GI17-00009
- Keywords
- Late term pregnancy, Doppler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 11 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Diagnostic Test: Ultrasound and Doppler ultrasoundThis 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. |
| Cases | – | Diagnostic Test: Ultrasound and Doppler ultrasoundCases will be patients with abnormal intrapartum cardiotocogram (category III fetal heart rate tracing). Intervention: Ultrasound and Doppler ultrasound |
| Controls | – | Diagnostic Test: Ultrasound and Doppler ultrasoundThose 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound and Doppler ultrasoundAlso: Pulsatility index, Amniotic fluid indexAssessment of fetal cerebral and maternal uterine pulsatility index using Doppler ultrasound. Measurement of amniotic fluid index according to four-quadrant technique. | Diagnostic test | Cases, Cohort, Controls |
Primary outcome
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
4 secondary outcomes
Middle cerebral artery pulsatility index
Time frame: 24 hours before delivery
Mean uterine artery pulsatility index
Time frame: 24 hours before delivery
Middle cerebral artery pulsatility index to mean uterine artery pulsatility index ratio
Time frame: 24 hours before delivery
Oligohydramnios
Time frame: 24 hours before delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Background: PubMed 28738721Lebovitz 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.
- Background: PubMed 16097973Lam 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.
- Background: PubMed 8142046Arabin 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.
- Background: PubMed 8096472Tongsong 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.
- Background: PubMed 25763408Adiga 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flavio Hernández-Castro, MD PhD principal investigator
Hospital Universitario Dr. José Eleuterio González UANL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormality in Fetal Heart Rate or Rhythm and Ultrasound, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Category III fetal heart rate tracings (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03703037, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.