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

Not Applicable
Completed
Conditions
Postpartum Anemia
Interventions
Other: Monitoring hemoglobin levels to detect anemia by screening of women at increased risk for post partum anemia
Other: Monitoring hemoglobin levels following anemia associated symptoms
Registration Number
NCT02434653
Lead Sponsor
HaEmek Medical Center, Israel
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
1679
Inclusion Criteria
  • pregnant women after vaginal delivery
Exclusion Criteria
  • pregnant women with known sensitivity to the product iron sucrose
  • pregnant women after cesarean section

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Postpartum anemia diagnosis following patients screeningMonitoring hemoglobin levels to detect anemia by screening of women at increased risk for post partum anemiaPost 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.
Postpartum anemia diagnosis following symptomsMonitoring hemoglobin levels following anemia associated symptomsPost 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
Primary Outcome Measures
NameTimeMethod
The rate of patients diagnosed with anemiaUp to 3 days postpartum

Hemoglobin of 10 g/dl or below

The rate of patients who received treatment with intravenous iron sucroseUp to 3 days postpartum
Secondary Outcome Measures
NameTimeMethod
The rate of patients who received blood transfusionFrom delivery and up to 5 days
The rate of women with post-partum hemorrhageFrom delivery and up to 5 days
The rate of women who underwent uterine revision following delivery after their arrival to the maternity wardFrom delivery and up to 5 days
The rate of women who needed uterotonic agents after their arrival to the maternity wardFrom delivery and up to 5 days
The average blood tests number that was performedFrom delivery and up to 5 days
Minimal and average hemoglobin levelFrom delivery and up to 5 days
The composite symptoms of anemia and functional capacity after 6 weeks postpartum as assessed by a questionnaire6 weeks postpartum

Each question in the questionnaire will receive a score. The total score will be reported.

Hemoglobin level 6 weeks postpartum6 weeks postpartum

Trial Locations

Locations (1)

Haemek Medical Center

🇮🇱

Afula, Israel

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