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

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ClinicalTrials.gov Identifier: NCT03478267
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Vered Lamhot MD, 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.

Condition or disease Intervention/treatment
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:

  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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Days
Official Title: The Relationship Between Fetal Baseline Heart-rate and the Level of Acetyl-choline Esterase in Fetal Blood
Actual Study Start Date : February 17, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. AChE levels in fetal blood [ Time Frame: Up to 5 minutes post delivery (either vaginal or cesarean) ]
    AChE levels obtained from the fetal umbilical cord after birth


Secondary Outcome Measures :
  1. AChE levels in maternal blood [ Time Frame: Up to 5 minutes post delivery (either vaginal or cesarean) ]
    AChE levels obtained from maternal peripheral blood after birth

  2. AChE levels in the placenta [ Time Frame: Up to 30 minutes post delivery (either vaginal or cesarean) ]
    AChE levels obtained from the placenta after birth



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female pregnant patients and their fetuses
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478267


Contacts
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Contact: Vered Lamhot, MD 0547720990 veryshick@hotmal.com

Locations
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Israel
Rambam hospital Recruiting
Haifa, Israel
Contact: Vered Lamhot, MD         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Vered Lamhot, MD Rambam Health Care Campus

Additional Information:

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Responsible Party: Vered Lamhot MD, Primary investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03478267     History of Changes
Other Study ID Numbers: 0584-16-RMB
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Acetylcholine
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents
Vasodilator Agents
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs