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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02434653
Enrollment
1679
Registered
2015-05-05
Start date
2015-06-30
Completion date
2017-05-31
Last updated
2017-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Anemia

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.

Interventions

OTHERMonitoring hemoglobin levels following anemia associated symptoms

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.

OTHERMonitoring hemoglobin levels to detect anemia by screening of women at increased risk for post partum anemia

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

Sponsors

HaEmek Medical Center, Israel
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* pregnant women after vaginal delivery

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
The rate of patients diagnosed with anemiaUp to 3 days postpartumHemoglobin of 10 g/dl or below
The rate of patients who received treatment with intravenous iron sucroseUp to 3 days postpartum

Secondary

MeasureTime frameDescription
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
The rate of patients who received blood transfusionFrom delivery and up to 5 days
The composite symptoms of anemia and functional capacity after 6 weeks postpartum as assessed by a questionnaire6 weeks postpartumEach question in the questionnaire will receive a score. The total score will be reported.
Hemoglobin level 6 weeks postpartum6 weeks postpartum
Minimal and average hemoglobin levelFrom delivery and up to 5 days
The rate of women with post-partum hemorrhageFrom delivery and up to 5 days

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026