- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06201910
Evaluation of Peripartum Blood Loss and Postpartum Anaemia in Macrosomia & Gemini
Retrospective Evaluation of Peripartum Blood Loss and Postpartum Anaemia With Respect to Fetal Macrosomia and Gemini
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patient blood management is essentially based on three pillars, and a meta-analysis has already shown that consistent use can reduce transfusions and mortality. The WHO defines anaemia in pregnant patients as a haemoglobin (Hb) concentration <11 g/dl.
Treatment of iron deficiency anaemia is essential because data show that iron deficiency anaemia is associated with increased maternal morbidity, fetal morbidity and mortality. Studies show a separate risk of bleeding in pregnant women due to increased uterine prolapse, for example in twin pregnancies or macrosomic singletons. At present, the prepartum anaemia management of patients, the influence of anaemia and the administration of foreign blood concentrates are insufficiently studied, which the investigators intend to investigate.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Hessen
-
Frankfurt, Hessen, Germany, 60590
- University Hospital Frankfurt
-
Frankfurt, Hessen, Germany, 60598
- Goethe University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnancy
Exclusion Criteria:
- pre-existing coagulation disorder
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Controll
Pregnant women without uterine dilation due to a twin pregnancy or a macrosomic singleton
|
Retrospetive observation of bloodloss and RBC transfusions.
|
|
Gemini
Pregnant women with uterine dilation due to a twin pregnancy
|
Retrospetive observation of bloodloss and RBC transfusions.
|
|
Makrosome
Pregnant women with uterine dilation due to a macrosomic singleton
|
Retrospetive observation of bloodloss and RBC transfusions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bloodloss
Time Frame: Within the first 24 hours after delivery
|
Blood loss measured by haemoglobin value
|
Within the first 24 hours after delivery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-1405
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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