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

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Completed

CT.gov ID

NCT03478267

Collaborator

(none)

101

Enrollment

Location

24.4

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fetal Heart Failure (Disorder)	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:

st group-fetal heart rate between 110-130 beats per minute (bpm).
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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

101 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 17, 2019

Actual Primary Completion Date :

Feb 1, 2021

Actual Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam hospital	Haifa		Israel

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator: Vered Lamhot, MD, Rambam Health Care Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vered Lamhot MD, Primary investigator, Rambam Health Care Campus

ClinicalTrials.gov Identifier:

NCT03478267

Other Study ID Numbers:

0584-16-RMB

First Posted:

Mar 27, 2018

Last Update Posted:

May 4, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of May 4, 2022