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CompletedNCT02434653Updated Jul 14, 2017

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

An interventional study of Monitoring hemoglobin levels following anemia associated symptoms and Monitoring hemoglobin levels to detect anemia by screening of women at increased risk for post partum anemia in Postpartum Anemia, sponsored by HaEmek Medical Center, Israel. Completed at 1 site in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-14.

Sponsored by HaEmek Medical Center, Israel · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
1,679
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Postpartum Anemia
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In context

Lead sponsor

HaEmek Medical Center, Israel is the lead sponsor of 237 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • pregnant women after vaginal delivery

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,679 participants (actual)

Study arms

  • Experimental
    Postpartum anemia diagnosis following symptoms

    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

  • Experimental
    Postpartum anemia diagnosis following patients screening

    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

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

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What researchers measure

Primary outcomes

  1. The rate of patients diagnosed with anemia

    Hemoglobin of 10 g/dl or below

    Time frame: Up to 3 days postpartum

  2. The rate of patients who received treatment with intravenous iron sucrose

    Time frame: Up to 3 days postpartum

Secondary outcomes

  1. The rate of patients who received blood transfusion

    Time frame: From delivery and up to 5 days

  2. The rate of women with post-partum hemorrhage

    Time frame: From delivery and up to 5 days

  3. The rate of women who underwent uterine revision following delivery after their arrival to the maternity ward

    Time frame: From delivery and up to 5 days

  4. The rate of women who needed uterotonic agents after their arrival to the maternity ward

    Time frame: From delivery and up to 5 days

  5. The average blood tests number that was performed

    Time frame: From delivery and up to 5 days

  6. Minimal and average hemoglobin level

    Time frame: From delivery and up to 5 days

  7. 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.

    Time frame: 6 weeks postpartum

  8. Hemoglobin level 6 weeks postpartum

    Time frame: 6 weeks postpartum

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Study locations

1 site
  • Haemek Medical Center
    Afula, Israel
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References and documents

Publications

  • 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. PubMed 33737646 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02434653
Responsible party
enav yefet (MD/PhD, HaEmek Medical Center, Israel) — Principal investigator
First posted
May 5, 2015
Start date
Jun 2015
Primary completion
May 2017
Completion
May 2017
Last update
Jul 14, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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