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

Completed

• Conditions: Fetal Heart Failure (Disorder)
• Interventions: Diagnostic Test: AChE levels

• Registration Number: NCT03478267
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-27
• Study Start: 2019-02-17
• Primary Completion: 2021-02-01
• Study Completion: 2021-03-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fetal heart rate 140-160 bpm	AChE levels	Pregnancies in which the fetal baseline heart rate is between 140 beats per minute and 160 beats per minute.
Fetal heart rate 110-130 bpm	AChE levels	Pregnancies in which the fetal baseline heart rate is between 110 beats per minute and 130 beats per minute.

Primary Outcome Measures

Name	Time	Method
AChE levels in fetal blood	Up to 5 minutes post delivery (either vaginal or cesarean)	AChE levels obtained from the fetal umbilical cord after birth

Secondary Outcome Measures

Name	Time	Method
AChE levels in maternal blood	Up to 5 minutes post delivery (either vaginal or cesarean)	AChE levels obtained from maternal peripheral blood after birth
AChE levels in the placenta	Up to 30 minutes post delivery (either vaginal or cesarean)	AChE levels obtained from the placenta after birth

Trial Locations

Locations (1)

Rambam hospital; 🇮🇱 Haifa, Israel