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

Rambam Health Care Campus

Status: Completed

Conditions: Fetal Heart Failure (Disorder)

Treatments: Diagnostic Test: AChE levels

Study type: Observational

Funder types: Other

Identifiers

NCT03478267

0584-16-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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

Trial design

101 participants in 2 patient groups

Fetal heart rate 110-130 bpm

Description:

Pregnancies in which the fetal baseline heart rate is between 110 beats per minute and 130 beats per minute.

Treatment:

Diagnostic Test: AChE levels

Fetal heart rate 140-160 bpm

Description:

Pregnancies in which the fetal baseline heart rate is between 140 beats per minute and 160 beats per minute.

Treatment:

Diagnostic Test: AChE levels