Name of the Procedure:

Injection, Hydroxyprogesterone Caproate (Makena), 10 mg

• Common Names: Hydroxyprogesterone Injection, Makena Injection
• Technical/Medical Term: Hydroxyprogesterone Caproate Injection

Summary

Hydroxyprogesterone caproate injection, commonly known as Makena, is an injectable medication used to help prevent preterm birth in women who are pregnant. The injection is usually given weekly in a healthcare setting.

Purpose

Medical Conditions or Problems Addressed:

• Prevention of recurrent preterm birth in women who have a history of spontaneous preterm delivery.

Goals or Expected Outcomes:

• To reduce the occurrence of preterm birth, thereby decreasing the risks associated with premature birth for the baby.

Indications

Symptoms or Conditions:

• A history of spontaneous preterm birth in a previous single pregnancy.

Patient Criteria:

• Women with a singleton pregnancy who have a history of spontaneous preterm birth (20 weeks to 36 weeks and 6 days of gestation).

Preparation

Pre-procedure Instructions:

• No special preparation is generally required.
• Inform your healthcare provider of any allergies, current medications, or medical conditions.

Diagnostic Tests or Assessments Required:

• Typically, a thorough review of the patient’s medical history and confirmation of the current singleton pregnancy.

Procedure Description

Step-by-Step Explanation:

1. The injection site (usually the buttocks) is cleaned with an antiseptic.
2. A healthcare professional administers the hydroxyprogesterone caproate injection into the muscle.
3. The injection is given once a week, starting between 16 to 20 weeks of pregnancy and continuing until week 37 or delivery.

Tools, Equipment, or Technology Used:

• Sterile syringes and needles.
• Hydroxyprogesterone caproate solution (Makena).

Anesthesia or Sedation Details:

• No anesthesia or sedation is typically required.

Duration

• Each injection administration takes only a few minutes.

Setting

• The procedure is typically performed in an outpatient clinic or doctor’s office.

Personnel

• Administered by healthcare professionals such as nurses or doctors.

Risks and Complications

Common Risks:

• Pain or swelling at the injection site.
• Mild itching or rash.

Rare Risks:

• Severe allergic reactions.
• Blood clots.

Possible Complications:

• Injection site infections.
• Managing complications usually involves symptomatic treatment and discontinuation if severe adverse reactions occur.

Benefits

• Reduced risk of recurrent preterm birth.
• Potentially improved outcomes for the baby, including reduced risks associated with prematurity.

Recovery

Post-Procedure Care and Instructions:

• Keep the injection site clean and dry.
• Report any unusual symptoms or severe discomfort to your healthcare provider immediately.

Expected Recovery Time:

• No significant recovery time; most patients can resume normal activities immediately.

Restrictions or Follow-up Appointments:

• Weekly follow-up appointments are necessary for subsequent injections.

Alternatives

Other Treatment Options:

• No FDA-approved alternatives specifically for the prevention of recurrent preterm birth, but close monitoring and other supportive measures may be employed.

Pros and Cons of Alternatives:

• Monitoring alone does not offer the proactive prevention provided by hydroxyprogesterone injections.

Patient Experience

During the Procedure:

• You may feel a brief sting or slight discomfort during the injection.

After the Procedure:

• Mild soreness or swelling at the injection site.
• Pain management can involve over-the-counter pain relievers if approved by your healthcare provider.
• Comfort measures include applying ice to the injection site if swelling or soreness occurs.

By following this procedure, patients can expect to manage their risk of preterm birth more effectively, leading to healthier pregnancy outcomes.