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

NCT02434653 | Completed

• 1 other identifier: 0112-14
• Study Type: interventional
• Target: 1,679
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Anemia

Outcome Measures

Primary Outcomes (2)

• The rate of patients diagnosed with anemia

  Hemoglobin of 10 g/dl or below

  Up to 3 days postpartum

• The rate of patients who received treatment with intravenous iron sucrose

  Up to 3 days postpartum

Secondary Outcomes (8)

• The rate of patients who received blood transfusion

  From delivery and up to 5 days

• The rate of women with post-partum hemorrhage

  From delivery and up to 5 days

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

  From delivery and up to 5 days

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

  From delivery and up to 5 days

• The average blood tests number that was performed

  From delivery and up to 5 days

Study Arms (2)

Postpartum anemia diagnosis following symptoms

EXPERIMENTAL

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

Postpartum anemia diagnosis following patients screening

EXPERIMENTAL

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

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.

Postpartum anemia diagnosis following symptoms

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

Postpartum anemia diagnosis following patients screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant women after vaginal delivery

You may not qualify if:

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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Haemek Medical Center

Afula, Israel

Location

Related Publications (1)

• 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.

  PMID: 33737646 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD/PhD

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 5, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 14, 2017

Record last verified: 2017-05

Locations

IL (1)