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

Fetal Heart Failure (Disorder) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478267
• Other study ID #: 0584-16-RMB
• Status: Completed
• Start date: February 17, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: May 2022
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Heart Failure (Disorder)
• Heart Failure

Intervention

Diagnostic Test:
• AChE levels
AChE levels in peripheral blood tests from maternal blood, fetal umbilical cord and placenta.

Locations

Country	Name	City	State
Israel	Rambam hospital	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AChE levels in fetal blood	AChE levels obtained from the fetal umbilical cord after birth	Up to 5 minutes post delivery (either vaginal or cesarean)
Secondary	AChE levels in maternal blood	AChE levels obtained from maternal peripheral blood after birth	Up to 5 minutes post delivery (either vaginal or cesarean)
Secondary	AChE levels in the placenta	AChE levels obtained from the placenta after birth	Up to 30 minutes post delivery (either vaginal or cesarean)