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NCT Number: NCT05873218

Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE

Labor analgesia is an important component of the care of laboring patients. A known side effect of combined spinal and epidural anesthesia (a type of labor analgesia) is an increased incidence of category II fetal heart rate tracing (defined below) and low blood pressure. The study team aims to study if a prophylactic dose of ephedrine will decrease the occurrence of this type of tracing after combined spinal epidural (CSE) anesthesia placement. Ephedrine is not currently routinely used as prevention for category II tracings or low blood pressure. The use of Ephedrine in this study is investigational (this is the first time that the drug has been studied for its effect on these conditions).

Fetal heart rate (FHR) tracings are classified into three categories. In clinical practice, FHR tracing categories are used as a guide to obstetric management and suggest the following approach:

* Category I tracing is "reactive" and reassuring → may continue labor * Category II tracing is neither category I nor category III. For obvious reasons, category II is the broadest and largest category, consisting of various FHR tracing patterns that do not fit into either category I or category III. * Category III tracing is non-reassuring → expedited vaginal or cesarean delivery recommended.

A Category II tracing is not diagnostic. Most pregnancies have at least one Category II tracing. There is not always an identifiable reason for a Category II tracing.

Ephedrine is a medication that causes an increase in heart rate and blood pressure while also causing some degree of relaxation of the uterus therefore improving uterine blood flow. It has been used in the obstetric population for over 50 years without issues. The dose that the research team will administer, 7.5 mg, is below the dose the research team will often administer to treat hypotension (low blood pressure).

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Icahn School of Medicine at Mount SInai

New York, 10029, United States

Location status: Recruiting

Location contact

Daniel Katz

PRINCIPAL_INVESTIGATOR

Daniel Katz, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women aged 18-55 years
  • Requesting labor analgesia
  • Able to provide informed written consent
  • Category 1 fetal tracing prior to placement of neuraxial anesthesia

Exclusion criteria

  • Refusal of neuraxial anesthesia
  • History of hypertension
  • Suspected pre-eclampsia
  • Category 2 or 3 fetal tracing prior to placement of neuraxial anesthesia

Treatment and study plan

Ephedrine

Drug

The intervention will be up to two 7.5 mg doses of ephedrine given after the placement of a combined spinal epidural with 25 mcg intrathecal fentanyl timed 3 and 15 minutes after intrathecal opiate administration.

Normal Saline Placebo

Drug

Placebo will be administered at matching rate.

Primary outcomes

  1. Incidence of category II fetal heart rate tracing

    Time frame: day 1, 30 minutes after administration of intrathecal opiate

    Incidence of category II fetal heart rate tracing up to 30 minutes after administration of intrathecal opiate

Secondary outcomes

  1. Incidence of uterine tetanic contractions

    Time frame: day 1, 30 minutes after administration of intrathecal opiate

    Incidence of uterine tetanic contractions after combined spinal epidural placement

  2. Incidence of uterine hypertorus

    Time frame: day 1, 30 minutes after administration of intrathecal opiate

    Incidence of uterine hypertorus up to 30 minutes after administration of intrathecal opiate

  3. Incidence of fetal bradycardia

    Time frame: day 1, 30 minutes after administration of intrathecal opiate

    Incidence of fetal bradycardia up to 30 minutes after administration of intrathecal opiate

  4. Incidence of rescue administration of ephedrine, terbutaline, or nitroglycerin

    Time frame: day 1, 30 minutes after administration of intrathecal opiate

    Incidence of rescue administration of ephedrine, terbutaline, or nitroglycerin up to 30 minutes after administration of intrathecal opiate

  5. Incidence of antihypertensive treatment after ephedrine administration

    Time frame: day 1, 30 minutes after administration of intrathecal opiate

    Incidence of antihypertensive treatment after ephedrine administration

  6. Incidence of urgent/emergent cesarean delivery

    Time frame: day 1, 30 minutes after administration of intrathecal opiate

    Incidence of urgent/emergent cesarean delivery within 30 minutes of intrathecal opiate administration

  7. Incidence of hypotension

    Time frame: day 1, 30 minutes after administration of intrathecal opiate

    Incidence of hypotension as defined as systolic blood pressure decrease of 20% versus baseline, systolic blood pressure under 90 mmHG, or symptoms of hypotension such as light headedness

  8. Average HR changes

    Time frame: day 1, 30 minutes after administration of intrathecal opiate

    Average HR changes 30 minutes after intrathecal opiate administration

  9. Average blood pressure changes

    Time frame: day 1, 30 minutes after administration of intrathecal opiate

    Average blood pressure changes 30 minutes after intrathecal opiate administration of systolic and diastolic blood pressure

  10. Number of patients with systolic blood pressure under 90 mmHG

    Time frame: End of study, at 6 months

    Systolic blood pressure under 90 mmHG, or symptoms of hypotension such as light headedness

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Katz, MD

CONTACT

[email protected]

212-241-7475

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After Combined Spinal Epidural on Laboring Parturients

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 24, 2023
Registry last updated
May 6, 2026

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.

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