Fetal Heart Failure (Disorder)NCT03478267
The Relationship Between Fetal Baseline Heart-rate and the Level of Acetyl-choline Esterase in Fetal Blood
An observational study of Fetal Heart Failure (Disorder), run by Rambam Health Care Campus at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Fetal Heart Failure (Disorder)
- What is being tested?
- AChE levels
- How many people
- 101 participants
- Where
- 1 siteIsrael
- Study dates
- 17 Feb 2019to 1 Mar 2021
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fetal Heart Failure (Disorder)
- Being tested
- AChE levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AChE levelsDiagnostic test
AChE levels in peripheral blood tests from maternal blood, fetal umbilical cord and placenta.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: AChE levels | |
| 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. Receives: Diagnostic Test: AChE levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
AChE levels in fetal blood
AChE levels obtained from the fetal umbilical cord after birth
Measured: Up to 5 minutes post delivery (either vaginal or cesarean)
Secondary outcomes (2)
AChE levels in maternal blood
AChE levels obtained from maternal peripheral blood after birth
Measured: Up to 5 minutes post delivery (either vaginal or cesarean)
AChE levels in the placenta
AChE levels obtained from the placenta after birth
Measured: Up to 30 minutes post delivery (either vaginal or cesarean)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start17 Feb 2019
- Primary completion1 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Heart Failure (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vered Lamhot MD, Rambam Health Care Campus
- Investigators
- Vered Lamhot, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478267
- Sponsor's protocol ID
- 0584-16-RMB
- Status last verified
- May 2022
- First submitted
- 20 Mar 2018
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Fetal Baseline Heart-rate and the Level of Acetyl-choline Esterase in Fetal Blood
- ClinicalTrials.gov ID
- NCT03478267
- Acronym / sponsor ID
- 0584-16-RMB
- Conditions
- Fetal Heart Failure (Disorder)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 17 Feb 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fetal heart rate 110-130 bpm | – | Diagnostic Test: AChE levelsPregnancies in which the fetal baseline heart rate is between 110 beats per minute and 130 beats per minute. |
| Fetal heart rate 140-160 bpm | – | Diagnostic Test: AChE levelsPregnancies in which the fetal baseline heart rate is between 140 beats per minute and 160 beats per minute. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AChE levelsAChE levels in peripheral blood tests from maternal blood, fetal umbilical cord and placenta. | Diagnostic test | Fetal heart rate 110-130 bpm, Fetal heart rate 140-160 bpm |
Primary outcome
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
2 secondary outcomes
AChE levels in maternal blood
Time frame: Up to 5 minutes post delivery (either vaginal or cesarean)
AChE levels in the placenta
Time frame: Up to 30 minutes post delivery (either vaginal or cesarean)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vered Lamhot, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Heart Failure (Disorder), run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AChE levels in fetal blood (time frame: Up to 5 minutes post delivery (either vaginal or cesarean)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.