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

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

Study Overview

• Status: Completed
• Conditions: Postpartum Anemia
• Intervention / Treatment: Other: Monitoring hemoglobin levels following anemia associated symptoms; Other: Monitoring hemoglobin levels to detect anemia by 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.

• Study Type: Interventional
• Enrollment (Actual): 1679
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel
    • HaEmek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• pregnant women after vaginal delivery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Minimal and average hemoglobin level		From delivery and up to 5 days
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.	6 weeks postpartum
Hemoglobin level 6 weeks postpartum		6 weeks postpartum

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ACTUAL): May 1, 2017
• Study Completion (ACTUAL): May 1, 2017

Study Registration Dates

• First Submitted: April 28, 2015
• First Submitted That Met QC Criteria: April 30, 2015
• First Posted (ESTIMATE): May 5, 2015

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Chrysarobin
• Other Study ID Numbers: 0112-14