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

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

Detailed Description
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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.

Official Title
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A Comparison Between Two Strategies for Postpartum Anemia Diagnosis and Follow up After Vaginal Deliveries - Hemoglobin Screening in High Risk Population Versus by Symptoms

Conditions
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Postpartum Anemia

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant women after vaginal delivery Exclusion Criteria: pregnant women with known sensitivity to the product iron sucrose pregnant women after cesarean section

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postpartum anemia diagnosis following symptoms<br>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 | Other: Monitoring hemoglobin levels following anemia associated symptoms<br>* Post-partum anemia will be diagnosed after vaginal delivery by taking hemoglobin levels to patients with symptoms consistent with anemia, severe postpartum hemorrhage or hemoglobin level below 8 g/dL.<br>|
| Experimental: Postpartum anemia diagnosis following patients screening<br>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. | Other: Monitoring hemoglobin levels to detect anemia by screening of women at increased risk for post partum anemia<br>* Post-partum anemia will be diagnosed after vaginal delivery by taking hemoglobin levels to high risk women for post-partum anemia, defined as hemoglobin levels of 10.5 g/dl or below around delivery, or severe postpartum hemorrhage with or without symptoms associated with anemia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of patients diagnosed with anemia | Hemoglobin of 10 g/dl or below | Up to 3 days postpartum | 
| The rate of patients who received treatment with intravenous iron sucrose |  | Up to 3 days postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of patients who received blood transfusion |  | From delivery and up to 5 days | 
| The rate of women with post-partum hemorrhage |  | From delivery and up to 5 days | 
| The rate of women who underwent uterine revision following delivery after their arrival to the maternity ward |  | From delivery and up to 5 days | 
| The rate of women who needed uterotonic agents after their arrival to the maternity ward |  | From delivery and up to 5 days | 
| The average blood tests number that was performed |  | From delivery and up to 5 days | 
| Minimal and average hemoglobin level |  | From delivery and up to 5 days | 
| The composite symptoms of anemia and functional capacity after 6 weeks postpartum as assessed by a questionnaire | Each question in the questionnaire will receive a score. The total score will be reported. | 6 weeks postpartum | 
| Hemoglobin level 6 weeks postpartum |  | 6 weeks postpartum |