Is it safe to take propofol (Propofol) during pregnancy?

From the Guidelines

Propofol should only be used during pregnancy when the potential benefits outweigh the risks to the developing fetus, typically in emergency situations requiring anesthesia, as stated by the American College of Obstetricians and Gynecologists (ACOG) guidance 1. When considering the use of propofol during pregnancy, it is essential to weigh the potential risks and benefits. According to the most recent study from 2024, propofol, fentanyl, and midazolam have not been associated with congenital malformations 1. However, the use of sedation or anesthesia during endoscopy raises risks of adverse effects on the fetus, including decreased placental blood flow and fetal hypoxia 1.

Key Considerations

• The American Society for Gastrointestinal Endoscopy recommends meperidine as the preferred agent for moderate sedation, followed by small doses of midazolam as needed, but attempts should be made to limit the use of midazolam during the first trimester 1.
• When deep sedation is needed, administration by an experienced anesthesiologist is advised 1.
• ACOG also advises fetal heart rate monitoring, depending on gestational age, facility type, and nature of the surgery, as monitoring may assist in maternal positioning and cardiopulmonary management 1.
• The FDA released a warning in 2017 about the possible risk of fetal brain damage and subsequent impairment of neurocognitive function after prolonged (>3 hours) or frequent exposure to general anesthetics and sedatives, including midazolam and propofol, during the third trimester of pregnancy 1.

Recommendations

• Propofol should be used with caution and only when necessary, taking into account the potential risks and benefits to the developing fetus.
• Pregnant women requiring anesthesia should discuss their specific circumstances with their obstetrician and anesthesiologist to determine the safest approach for both mother and baby.
• Alternative anesthetics might be considered depending on the specific medical situation.
• Fetal heart rate monitoring and careful maternal positioning are crucial to minimize risks during anesthesia administration.

From the FDA Drug Label

Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women In animal reproduction studies, decreased pup survival concurrent with increased maternal mortality was observed with intravenous administration of propofol to pregnant rats either prior to mating and during early gestation or during late gestation and early lactation at exposures less than the human induction dose of 2. 5 mg/kg.

Labor and Delivery Propofol injectable emulsion is not recommended for obstetrics, including cesarean section deliveries.

Key Points:

• There are no adequate and well-controlled studies in pregnant women.
• Animal studies show decreased pup survival and increased maternal mortality.
• Propofol is not recommended for obstetrics, including cesarean section deliveries.

It is not safe to take propofol during pregnancy due to the lack of adequate and well-controlled studies in pregnant women and the potential risks observed in animal studies 2.

From the Research

Safety of Propofol During Pregnancy

• The use of propofol during pregnancy has been studied, and the results suggest that it can be used safely in certain situations 3.
• One study found that propofol has no major advantages over thiopentone for the induction of anesthesia in pregnancy, but it does give satisfactory results and should be available as an alternative 3.
• Another study found that early pregnancy does not reduce the C(50) of propofol for loss of consciousness, indicating that the concentration of propofol required for loss of consciousness is the same in pregnant and non-pregnant women 4.
• A case report described the prolonged use of propofol for sedation in a critically ill pregnant patient, but the safety of propofol for long-term use during pregnancy is still unknown 5.
• Propofol is classified as a pregnancy category B drug, but data are lacking on its safe use during pregnancy and long-term developmental outcomes in children after exposure to propofol in utero 5.
• In contrast, other studies have focused on the safety of biologic agents during pregnancy, which may not be directly relevant to the use of propofol 6, 7.

Key Findings

• Propofol can be used safely for induction and maintenance of general anesthesia during pregnancy 3.
• The concentration of propofol required for loss of consciousness is the same in pregnant and non-pregnant women 4.
• There is limited data on the safety of propofol for long-term use during pregnancy 5.
• Propofol is classified as a pregnancy category B drug, but more research is needed to fully understand its safety profile during pregnancy 5.