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OpenTrials
Completed

NCT Number: NCT03478267

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.

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Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

Rambam hospital

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AChE levels

Diagnostic Test

AChE levels in peripheral blood tests from maternal blood, fetal umbilical cord and placenta.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 27, 2018
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.