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The Relationship Between Fetal Baseline Heart-rate and the Level of Acetyl-choline Esterase in Fetal Blood

The Relationship Between Fetal Baseline Heart-rate and the Level of Acetyl-choline Esterase in Fetal Blood

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03478267
Enrollment
101
Registered
2018-03-27
Start date
2019-02-17
Completion date
2021-03-01
Last updated
2022-05-04

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

Conditions

Fetal Heart Failure (Disorder)

Brief summary

Pregnant women between 32-41 weeks' gestation designated for either vaginal birth or cesarean section will be recruited for the study. Data regarding maternal resting heart rate and fetal baseline heart rate as depicted on the monitor will be collected. A blood sample will be acquired from the parturient and the umbilical cord as well as a sample from the placenta will be obtained. Levels of Acetyl Choline Esterase (AChE) will be determined from all aforementioned samples. Statistical correlation between fetal baseline heart rate and fetal and maternal AChE levels will be assessed.

Detailed description

Pregnant women between 32-41 weeks' gestation designated for either vaginal birth or cesarean section will be recruited for the study. After signing an informed consent, data regarding maternal resting heart rate and fetal baseline heart rate as depicted on the monitor will be collected. Patients will be divided into 2 equal groups according to fetal baseline heart rate: 1. st group-fetal heart rate between 110-130 beats per minute (bpm). 2. nd group-fetal heart rate between 140-160 bpm. A blood sample will be acquired from the parturient and the umbilical cord as well as a sample from the placenta will be obtained. Levels of Acetyl Choline Esterase (AChE) will be determined from all aforementioned samples. Statistical correlation between fetal baseline heart rate and fetal and maternal AChE levels will be assessed. Data regarding demographic, medical and obstetric information of the participants will be obtained from the hospital's electronic records.

Interventions

DIAGNOSTIC_TESTAChE levels

AChE levels in peripheral blood tests from maternal blood, fetal umbilical cord and placenta.

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No

Inclusion criteria

* Pregnant women between 32 and 41 weeks' gestation undergoing either vaginal or cesarean delivery with a fetal baseline heart rate of 110-130 beats per minute and 140-160 beats per minute.

Exclusion criteria

1. Delivery before 32 weeks of gestation 2. Maternal bradycardic (\<60) or tachycardic (\>100) resting heart rate. 3. Fetal bradycardia (\<110) or tachycardia (\>160). 4. Suspected chorioamnionitis 5. Maternal diseases which can affect her heart rate such as: 1. Cardiac disease (including arrhythmias) 2. Diseases of the thyroid gland 3. Rheumatic diseases 6. Use of medication which alters heart rate such as: 1. Beta blockers 2. Beta agonists 3. Cocaine, amphetamines 7. Use of Pethidine and Phenergan during delivery

Design outcomes

Primary

MeasureTime frameDescription
AChE levels in fetal bloodUp to 5 minutes post delivery (either vaginal or cesarean)AChE levels obtained from the fetal umbilical cord after birth

Secondary

MeasureTime frameDescription
AChE levels in maternal bloodUp to 5 minutes post delivery (either vaginal or cesarean)AChE levels obtained from maternal peripheral blood after birth
AChE levels in the placentaUp to 30 minutes post delivery (either vaginal or cesarean)AChE levels obtained from the placenta after birth

Countries

Israel

Outcome results

None listed

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