A Comparison Between Two Strategies for Postpartum Anemia Diagnosis and Follow up After Vaginal Deliveries

HaEmek Medical Center, Israel

Status: Completed

Conditions: Postpartum Anemia

Treatments: Other: Monitoring hemoglobin levels following anemia associated symptoms; Other: Monitoring hemoglobin levels to detect anemia by screening of women at increased risk for post partum anemia

Study type: Interventional

Funder types: Other

Identifiers

NCT02434653

0112-14

Details and patient eligibility

About

Anemia diagnosis by hemoglobin level monitoring in women after vaginal delivery by symptoms versus screening of women at increased risk for post-partum anemia.

Full description

Anemia is common following delivery. It is associated with some serious complications including increased risk for syncope and in severe cases even cardiogenic shock. Yet, anemia-associated symptoms might manifest relatively late after the patient have lost a fair amount of blood, which was not diagnosed early enough. To date, there are not acceptable guidelines for monitoring hemoglobin levels after delivery. Theoretically, there are 2 approaches for hemoglobin monitoring - one by taking hemoglobin levels in order to diagnose anemia in patients reporting anemia-associated symptoms. The other approach is by screening of women at increased risk for post-partum anemia. In the present study we aimed to compare those 2 approaches.

Enrollment: 1,679 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pregnant women after vaginal delivery

Exclusion criteria

• pregnant women with known sensitivity to the product iron sucrose
• pregnant women after cesarean section

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,679 participants in 2 patient groups

Postpartum anemia diagnosis following symptoms

Experimental group

Description:

Post partum anemia will be assessed by taking hemoglobin level following symptoms consistent with anemia, severe postpartum hemorrhage or hemoglobin level below 8 g/dL in the first 5 days following delivery

Treatment:

Other: Monitoring hemoglobin levels following anemia associated symptoms

Postpartum anemia diagnosis following patients screening

Experimental group

Description:

Post partum anemia will be assessed by taking hemoglobin level in patients at increased risk to develop post-partum anemia in the first 5 days following delivery, defined as patients with initial (before or immediately after delivery) hemoglobin level of 10.5 g/dl or less regardless of symptoms, or in cases of severe post partum hemorrhage.

Treatment:

Other: Monitoring hemoglobin levels to detect anemia by screening of women at increased risk for post partum anemia