Add a Pregnancy Case

Vault Safety supports collecting information on pregnancy exposure to products and the birth outcome associated with each pregnancy.

Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.

About Pregnancy Case Intake

This section applies to entering pregnancy information on Inbox Items and marking Inbox Items as a Pregnancy Case. You can track pregnancy exposure and report adverse events experienced by the mother during Case intake.

When you promote the Inbox Item to a Case, the pregnancy information is copied to the Case.

See other sections in this article for adding a Pregnancy Case during Case processing.

Prerequisites

Your Admin must have enabled Pregnancy Case Intake to use this feature. This enablement article includes instructions for adding the relevant fields to the Inbox Item layout.

Mark a Manually Created Inbox Item as a Pregnancy Case

To mark an Inbox Item as a Pregnancy Case, perform the following steps:

Go to the Inbox Item of interest.
In the Patients section, select the Pregnancy Case checkbox.
Save the Inbox Item.

Note: If you do not see this checkbox, your Admin must add it to the layout.

What Happens When You Promote an Inbox Item with Pregnancy Information

When you promote an Inbox Item (manual or imported from API) with pregnancy information to a Case or multiple Cases, Vault copies the pregnancy field values to the Case. These pregnancy fields will also appear on the Inbox Item to Case Compare page.

Vault automatically creates a Child Information Case and Child Information Test Results with the Case.

For Inbox Items imported from API, the number of Child records created depends on the Number of Fetuses. For example, if the value of the Number of Fetuses is 2, Vault creates two (2) child records. If there is no value for the Number of Fetuses, Vault creates one (1) Child record.

Note: This capability is available only for API-imported Inbox Items, not E2B-imported or manually created Inbox Items.

Each child record is linked to the main Case in the Linked Cases section. For each linked child record, the Retransmit field is set to Yes by default. This means that the linked records will automatically be E2B-compliant.

Tracking Pregnancy Exposure to Products

Add Pregnancy Cases to track pregnancy exposure to company products. Use the Pregnancy checkbox on a Case to identify that the patient is pregnant.

To track a pregnancy, open a Case for the pregnant patient. You can specify the following settings on a Case to track a pregnancy with no adverse event data:

Set event MedDRA to No adverse event (10067482)
Select the Pregnancy checkbox
Leave the Seriousness field Blank (Null)
To suppress submissions and exclude the Case from aggregate reports, select Suppress Submissions

In case of an adverse event in the mother, you can update that Case with the adverse event information.

Note: You must track a case using the standard Case object type to be able to submit or distribute the report, if required.

Prerequisites

Ensure the Pregnancy and Parent-Child Case Data Collection feature is enabled in your Vault.

Entering Birth Outcomes

If an adverse event occurs in the fetus or child, it must be captured and reported using a standard Case. See example scenarios below for more information.

Adverse Event in Child

Capture the adverse event in the child in a standard Case and link the Pregnancy Case as a Linked Case.

You must link the Child Case with a Parent Information Case in the Parent Information field for E2B transmissions. To do so, you must create a Parent Information record.

No Adverse Event in Child

When the child does not experience an adverse reaction, capture information about the child in a Child Information (child_information__v) type Case.

Create the Child Information Case from the Case for the tracked pregnancy to link the two Cases together.

E2B Transmission of Parent-Child Cases

For E2B compliant transmission of parent information for parent-child cases, in section D.10 for E2B(R3) or B.1.10 for E2B(R2), you must link the Parent and Child Cases using the Parent Information field.

See E2B Generation Data Mapping for more information.

Example Pregnancy and Birth Outcome Scenarios

The following example scenarios outline how to capture pregnancy outcomes for the mother and child in an E2B-compliant way:

Example 1: No Adverse Event in Mother or Child
Example 2: Adverse Event in Mother, No Adverse Event in Child
Example 3: Adverse Event in Child, No Adverse Event in Mother
Example 4: Adverse Event in Both Mother and Child

Note: In the following example scenarios, it is assumed that you are already tracking the pregnancy in a standard Case with no adverse event.

Example 1: No Adverse Event in Mother or Child

Update the Case for the tracked pregnancy to add information about the pregnancy outcome.
From the Case for the tracked pregnancy, add a Child Information-type Case to enter the details of the child.
This will automatically reference the tracked pregnancy case in the Parent Information field on the Child Information Case.
Add a reference to the Child Information Case from the Linked Cases section on the Case tracking the pregnancy.

Example 2: Adverse Event in Mother, No Adverse Event in Child

Update the Case for the tracked pregnancy to add information about the pregnancy outcome and the mother’s adverse event.
From the Case for the tracked pregnancy, add a Child Information-type Case to enter the details of the child.
This will automatically reference the tracked pregnancy case in the Parent Information field on the Child Information Case.
Add a reference to the Child Information Case from the Linked Cases section on the Case tracking the pregnancy.

Example 3: Adverse Event in Child, No Adverse Event in Mother

Update the Case for the tracked pregnancy to add information about the pregnancy outcome.
Open a standard Case (not Child Information) to capture the adverse event in the child.
From the Parent Information field on the Case for the child, add a Parent Information Case with details about the parent.
Link the Case for the tracked pregnancy to the child Case using a Linked Case relationship.

Note: You cannot change a regular Case object type to Parent Information type. You must open a separate Parent Information-type Case.

Note: The Case for the adverse event in the child must link to the Parent Case in the Parent Information field for E2B-compliant transmission of data in section D.10 for E2B(R3) or B.1.10 for E2B(R2).

Example 4: Adverse Event in Both Mother and Child

Update the Case for the tracked pregnancy to add information about the pregnancy outcome and the mother’s adverse event.
Open a standard Case (not Child Information) to capture the adverse event in the child.
From the Parent Information field on the Case for the child, add a Parent Information Case with details about the parent.
Link the Case for the tracked pregnancy to the child Case using a Linked Case relationship.

Note: You cannot change a regular Case object type to Parent Information type. You must open a separate Parent Information-type Case.

Add a Child Information Case

If the pregnancy outcome does not result in an adverse event in the fetus or infant, add a Child Information type Case.

You can add the Child Information Case directly from the pregnancy Parent Information Case from the Child Cases section. The Parent and Child Cases are automatically linked to each other.

Enter Case Data: Child Information Section provides more information on creating and performing data entry on Child Information Cases.

Child Information Test Results

Once you save the Child Information Case, Vault creates Case Test Result records for you to capture the following information:

1, 5, and 10 minute APGAR scores
Birth Outcome
Head Circumference

If the Parent Information Case references a MedDRA version, the above Test Results, except Birth Outcome, are auto-coded.