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

Primary Purpose

Postpartum Anemia

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Monitoring hemoglobin levels following anemia associated symptoms

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

About this trial

This is an interventional diagnostic trial for Postpartum Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

pregnant women after vaginal delivery

Exclusion Criteria:

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

Sites / Locations

Haemek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Postpartum anemia diagnosis following symptoms

Postpartum anemia diagnosis following patients screening

Arm Description

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

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.

Outcomes

Primary Outcome Measures

The rate of patients diagnosed with anemia

Hemoglobin of 10 g/dl or below

The rate of patients who received treatment with intravenous iron sucrose

Secondary Outcome Measures

The rate of patients who received blood transfusion

The rate of women with post-partum hemorrhage

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

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

The average blood tests number that was performed

Minimal and average hemoglobin level

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.

Hemoglobin level 6 weeks postpartum

Full Information

NCT ID

NCT02434653

First Posted

April 28, 2015

Last Updated

July 12, 2017

Sponsor

HaEmek Medical Center, Israel

1. Study Identification

Unique Protocol Identification Number

NCT02434653

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postpartum Anemia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1679 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Postpartum anemia diagnosis following symptoms

Arm Type

Experimental

Arm Description

Arm Title

Postpartum anemia diagnosis following patients screening

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Monitoring hemoglobin levels following anemia associated symptoms

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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 Outcome Measure Information:

Title

The rate of patients diagnosed with anemia

Description

Hemoglobin of 10 g/dl or below

Time Frame

Up to 3 days postpartum

Title

The rate of patients who received treatment with intravenous iron sucrose

Time Frame

Up to 3 days postpartum

Secondary Outcome Measure Information:

Title

The rate of patients who received blood transfusion

Time Frame