Postpartum AnemiaNCT02434653
A Comparison Between Two Strategies for Postpartum Anemia Diagnosis and Follow up After Vaginal Deliveries
A study testing Monitoring hemoglobin levels following anemia associated symptoms and Monitoring hemoglobin levels to detect anemia by screening of women at increased risk for post partum anemia in people with Postpartum Anemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Anemia
- What is being tested?
- Monitoring hemoglobin levels following anemia associated symptoms and Monitoring hemoglobin levels to detect anemia by screening of women at increased risk for post partum anemia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,679 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant women after vaginal delivery
Who cannot join
- pregnant women with known sensitivity to the product iron sucrose
- pregnant women after cesarean section
Trial locations and contacts
1 site in 1 country.
About this study
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
Anemia diagnosis by hemoglobin level monitoring in women after vaginal delivery by symptoms versus screening of women at increased risk for post-partum anemia.
Read the 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.
- Conditions
- Postpartum Anemia
- Being tested
- Monitoring hemoglobin levels following anemia associated symptoms, Monitoring hemoglobin levels to detect anemia by screening of women at increased risk for post partum anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring hemoglobin levels following anemia associated symptomsOther
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 anemiaOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Monitoring hemoglobin levels to detect anemia by screening of women at increased risk for post partum anemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients diagnosed with anemia
Hemoglobin of 10 g/dl or below
Measured: Up to 3 days postpartum
The rate of patients who received treatment with intravenous iron sucrose
Measured: Up to 3 days postpartum
Secondary outcomes (8)
The rate of patients who received blood transfusion
Measured: From delivery and up to 5 days
The rate of women with post-partum hemorrhage
Measured: From delivery and up to 5 days
The rate of women who underwent uterine revision following delivery after their arrival to the maternity ward
Measured: From delivery and up to 5 days
The rate of women who needed uterotonic agents after their arrival to the maternity ward
Measured: From delivery and up to 5 days
The average blood tests number that was performed
Measured: From delivery and up to 5 days
Minimal and average hemoglobin level
Measured: 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.
Measured: 6 weeks postpartum
Hemoglobin level 6 weeks postpartum
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,679 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, enav yefet, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434653
- Sponsor's protocol ID
- 0112-14
- Status last verified
- May 2017
- First submitted
- 28 Apr 2015
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 33737646
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02434653
- Acronym / sponsor ID
- 0112-14
- Conditions
- Postpartum Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,679 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postpartum anemia diagnosis following symptoms | Experimental | Other: Monitoring hemoglobin levels following anemia associated symptomsPost 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 |
| Postpartum anemia diagnosis following patients screening | Experimental | Other: Monitoring hemoglobin levels to detect anemia by screening of women at increased risk for post partum anemiaPost 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- pregnant women after vaginal delivery
Key exclusion criteria (2 listed)
- pregnant women with known sensitivity to the product iron sucrose
- pregnant women after cesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring hemoglobin levels following anemia associated symptomsPost-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. | Other | Postpartum anemia diagnosis following symptoms |
| Monitoring hemoglobin levels to detect anemia by screening of women at increased risk for post partum anemiaPost-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 | Other | Postpartum anemia diagnosis following patients screening |
Primary outcome
The rate of patients diagnosed with anemia
Time frame: Up to 3 days postpartum
Hemoglobin of 10 g/dl or below
The rate of patients who received treatment with intravenous iron sucrose
Time frame: Up to 3 days postpartum
8 secondary outcomes
The rate of patients who received blood transfusion
Time frame: From delivery and up to 5 days
The rate of women with post-partum hemorrhage
Time frame: From delivery and up to 5 days
The rate of women who underwent uterine revision following delivery after their arrival to the maternity ward
Time frame: From delivery and up to 5 days
The rate of women who needed uterotonic agents after their arrival to the maternity ward
Time frame: From delivery and up to 5 days
The average blood tests number that was performed
Time frame: From delivery and up to 5 days
Minimal and average hemoglobin level
Time frame: From delivery and up to 5 days
The composite symptoms of anemia and functional capacity after 6 weeks postpartum as assessed by a questionnaire
Time frame: 6 weeks postpartum
Hemoglobin level 6 weeks postpartum
Time frame: 6 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Derived from this study: PubMed 33737646Yefet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring hemoglobin levels following anemia associated symptoms and Monitoring hemoglobin levels to detect anemia by screening of women at increased risk for post partum anemia in people with Postpartum Anemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of patients diagnosed with anemia (time frame: Up to 3 days postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02434653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2017.