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

NCT ID: NCT02434653

Last Updated: 2017-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1679 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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Postpartum Anemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Monitoring hemoglobin levels following anemia associated symptoms

Intervention Type 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 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.

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* pregnant women after vaginal delivery

Exclusion Criteria

* pregnant women with known sensitivity to the product iron sucrose
* pregnant women after cesarean section
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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enav yefet

MD/PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Haemek Medical Center

Afula, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 33737646 (View on PubMed)

Other Identifiers

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0112-14

Identifier Type: -

Identifier Source: org_study_id

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