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

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.

Study Overview

• Status: Completed
• Conditions: Fetal Heart Failure (Disorder)
• Intervention / Treatment: Diagnostic test: AChE levels

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 Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fetal heart rate 110-130 bpm; Pregnancies in which the fetal baseline heart rate is between 110 beats per minute and 130 beats per minute.	Diagnostic test: AChE levels; AChE levels in peripheral blood tests from maternal blood, fetal umbilical cord and placenta.
Fetal heart rate 140-160 bpm; Pregnancies in which the fetal baseline heart rate is between 140 beats per minute and 160 beats per minute.	Diagnostic test: AChE levels; AChE levels in peripheral blood tests from maternal blood, fetal umbilical cord and placenta.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Vered Lamhot, MD, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 17, 2019
• Primary Completion (ACTUAL): February 1, 2021
• Study Completion (ACTUAL): March 1, 2021

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (ACTUAL): March 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 0584-16-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No