What are the treatment options for a 13-week pregnant patient presenting with gastroesophageal reflux disease (GERD) in a hospital setting?

From the Guidelines

For a pregnant patient at 13 weeks with GERD symptoms in a hospital setting, I would recommend starting with lifestyle modifications and non-pharmacological approaches first, such as small frequent meals, avoiding trigger foods, not eating within 3 hours of bedtime, and elevating the head of the bed. If medication is necessary, antacids containing calcium carbonate or aluminum hydroxide (like Tums or Maalox) are considered first-line therapy and are safe in pregnancy, as per the latest guidelines from the American College of Gastroenterology 1. The patient's symptoms can be assessed using the Motherisk Pregnancy Unique Quantification of Emesis score, which can help quantify the severity of nausea and vomiting 1. Some key points to consider when managing GERD in pregnancy include:

• Avoiding spicy, fatty, acidic, and fried foods to reduce heartburn
• Eating small, frequent, and bland meals, such as the BRAT (bananas, rice, applesauce, and toast) diet
• Identifying and avoiding specific triggers, such as certain foods with strong odors or activities
• Considering ginger (a 250-mg capsule 4 times daily) and vitamin B6 (pyridoxine, 10–25 mg every 8 hours) as therapeutic options, as recommended by the American College of Obstetricians and Gynecologists (ACOG) 1
• Reserving H1-receptor antagonists, such as doxylamine, promethazine, and dimenhydrinate, for persistent symptoms that do not respond to non-pharmacologic therapy, as they are considered safe first-line pharmacologic antiemetic therapies 1. It's essential to follow a step-up approach, starting with the safest options first, to manage symptoms while minimizing potential risks to the developing fetus, as the first trimester is a critical period for organogenesis, though most of these medications have good safety profiles in pregnancy.

From the FDA Drug Label

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with omeprazole in pregnant women. Available epidemiologic data from studies in Sweden and Denmark reported that exposure to omeprazole during pregnancy was not associated with a significantly increased risk of major birth defects or other adverse pregnancy outcomes. Reproductive studies in rats and rabbits with oral doses of omeprazole up to 138 mg/kg (about 34 times the human dose of 40 mg/day based on body surface area for a 160 kg person) and 69 mg/kg (about 17 times the human dose of 40 mg/day based on body surface area for a 150 kg person), respectively, did not disclose any evidence for a teratogenic potential of omeprazole. In rabbits, omeprazole in a dose of 69 mg/kg (about 17 times the human dose of 40 mg/day based on body surface area for a 150 kg person) produced dose-related increases in embryo-lethality, fetal resorptions, and pregnancy disruptions. In rats, dose-related increases in fetal resorptions and pregnancy disruptions were observed at doses equal to or greater than 13.8 mg/kg (about 3.4 times the human dose of 40 mg/day based on body surface area for a 150 kg person). When maternal toxicity was observed at doses of 13.8 mg/kg (about 3.4 times the human dose of 40 mg/day based on body surface area for a 150 kg person) or greater, there were slight and marked increases in fetal resorptions and pregnancy disruptions, respectively. For the treatment of GERD and EE, the usual recommended dose of omeprazole is 20 mg once daily. For the treatment of active duodenal ulcer, the usual recommended dose of omeprazole is 20 mg once daily for 4 weeks.

The patient is 13 weeks pregnant and complaining of GERD.

• Pregnancy category: The FDA drug label does not explicitly state a pregnancy category for omeprazole.
• Recommended dose for GERD: The recommended dose for GERD is 20 mg once daily for up to 4 weeks.
• Use in pregnancy: There are no adequate and well-controlled studies with omeprazole in pregnant women, but available epidemiologic data suggest that exposure to omeprazole during pregnancy was not associated with a significantly increased risk of major birth defects or other adverse pregnancy outcomes. Based on the available information, omeprazole 20 mg once daily can be considered for the treatment of GERD in a pregnant patient, but this decision should be made with caution and under the guidance of a healthcare provider, considering the potential risks and benefits 2.

From the Research

Treatment Options for GERD in Pregnancy

The patient is 13 weeks pregnant and complaining of GERD. The following treatment options can be considered:

• Lifestyle modification as the first step 3
• Calcium-containing antacids as the preferred choice of antacids 3, 4
• Sucralfate can be introduced if symptoms persist with antacids 3, 4, 5
• Histamine-2 receptor antagonist (H2RA) can be used if symptoms persist 3, 4, 5
• Proton pump inhibitors (PPIs) can be used in cases of inadequate control with H2RA and antacids, except for omeprazole 3, 4, 5

Medication Considerations

When considering medication, the following should be taken into account:

• Alginic acid and sucralfate can be used in pregnant women with GERD 4, 5
• Calcium- and magnesium-based antacids can be used, particularly for patients with preeclampsia 4
• Ranitidine, a histamine-2 receptor blocker, is preferred 4
• PPIs, except omeprazole, can be given after the first trimester, considering the benefit-harm ratio for the mother and fetus 4, 5

Treatment Approach

The treatment approach for GERD in pregnancy should follow a step-up approach, starting with lifestyle modification and progressing to medication if necessary 3, 5. The goal is to alleviate heartburn and regurgitation without jeopardizing the pregnancy or its outcome 3.