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

Postpartum Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434653
• Other study ID #: 0112-14
• Status: Completed
• Phase: N/A
• First received: April 28, 2015
• Last updated: July 12, 2017
• Start date: June 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1679
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pregnant women after vaginal delivery

Exclusion Criteria:

• pregnant women with known sensitivity to the product iron sucrose

• pregnant women after cesarean section

Related Conditions & MeSH terms

• Anemia
• Postpartum Anemia

Intervention

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.
• 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

Locations

Country	Name	City	State
Israel	Haemek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of patients diagnosed with anemia	Hemoglobin of 10 g/dl or below	Up to 3 days postpartum
Primary	The rate of patients who received treatment with intravenous iron sucrose		Up to 3 days postpartum
Secondary	The rate of patients who received blood transfusion		From delivery and up to 5 days
Secondary	The rate of women with post-partum hemorrhage		From delivery and up to 5 days
Secondary	The rate of women who underwent uterine revision following delivery after their arrival to the maternity ward		From delivery and up to 5 days
Secondary	The rate of women who needed uterotonic agents after their arrival to the maternity ward		From delivery and up to 5 days
Secondary	The average blood tests number that was performed		From delivery and up to 5 days
Secondary	Minimal and average hemoglobin level		From delivery and up to 5 days
Secondary	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
Secondary	Hemoglobin level 6 weeks postpartum		6 weeks postpartum