Clinical trial NCT02434653: A Comparison Between Two Strategies for Postpartum Anemia Diagnosis and Follow up After Vaginal Deliveries
Official title: A Comparison Between Two Strategies for Postpartum Anemia Diagnosis and Follow up After Vaginal Deliveries - Hemoglobin Screening in High Risk Population Versus by Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Anemia
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 1679
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* pregnant women after vaginal delivery

Exclusion Criteria:

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

Primary outcomes:
measure: The rate of patients diagnosed with anemia
timeFrame: Up to 3 days postpartum
measure: The rate of patients who received treatment with intravenous iron sucrose
timeFrame: Up to 3 days postpartum
Secondary outcomes:
measure: The rate of patients who received blood transfusion
timeFrame: From delivery and up to 5 days
measure: The rate of women with post-partum hemorrhage
timeFrame: From delivery and up to 5 days
measure: The rate of women who underwent uterine revision following delivery after their arrival to the maternity ward
timeFrame: From delivery and up to 5 days
measure: The rate of women who needed uterotonic agents after their arrival to the maternity ward
timeFrame: From delivery and up to 5 days
measure: The average blood tests number that was performed
timeFrame: From delivery and up to 5 days
measure: Minimal and average hemoglobin level
timeFrame: From delivery and up to 5 days
measure: The composite symptoms of anemia and functional capacity after 6 weeks postpartum as assessed by a questionnaire
timeFrame: 6 weeks postpartum
measure: Hemoglobin level 6 weeks postpartum
timeFrame: 6 weeks postpartum
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
References:
citation: Yefet E, Yossef A, Nachum Z. Prediction of anemia at delivery. Sci Rep. 2021 Mar 18;11(1):6309. doi: 10.1038/s41598-021-85622-7.