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Completed

NCT Number: NCT02434653

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

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

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Key information

Conditions

Postpartum Anemia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Haemek Medical Center

Afula, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant women after vaginal delivery

Exclusion criteria

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

Treatment and study plan

Monitoring hemoglobin levels following anemia associated symptoms

Other

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.

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

Other

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

Primary outcomes

  1. The rate of patients diagnosed with anemia

    Time frame: Up to 3 days postpartum

    Hemoglobin of 10 g/dl or below

  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

    Time frame: 6 weeks postpartum

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

  8. Hemoglobin level 6 weeks postpartum

    Time frame: 6 weeks postpartum

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 5, 2015
Registry last updated
Jul 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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