Evaluation of Peripartum Blood Loss and Postpartum Anaemia in Macrosomia & Gemini

NCT ID: NCT06201910

Last Updated: 2025-05-07

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

Total Enrollment

575 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-02-01

Brief Summary

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Anaemia in pregnant women occurs at a haemoglobin (Hb) concentration \<11 g/dL and treatment is essential to prevent increased maternal morbidity, fetal morbidity and mortality. Studies show a distinct risk of haemorrhage in pregnant women due to increased uterine dilatation, due to twins or macrosomic singletons. Currently, prepartum anaemia management, the influence of anaemia and the administration of foreign blood concentrates are insufficiently studied. The investigators intend to conduct a monocentric retrospective analysis of this subcohort.

Detailed Description

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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.

Conditions

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Bloodloss in Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Controll

Pregnant women without uterine dilation due to a twin pregnancy or a macrosomic singleton

Observation of Blood loss

Intervention Type OTHER

Retrospetive observation of bloodloss and RBC transfusions.

Gemini

Pregnant women with uterine dilation due to a twin pregnancy

Observation of Blood loss

Intervention Type OTHER

Retrospetive observation of bloodloss and RBC transfusions.

Makrosome

Pregnant women with uterine dilation due to a macrosomic singleton

Observation of Blood loss

Intervention Type OTHER

Retrospetive observation of bloodloss and RBC transfusions.

Interventions

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Observation of Blood loss

Retrospetive observation of bloodloss and RBC transfusions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnancy

Exclusion Criteria

* pre-existing coagulation disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Goethe University

OTHER

Sponsor Role lead

Responsible Party

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Armin N. Flinspach

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Frankfurt

Frankfurt am Main, Hesse, Germany

Site Status

Goethe University

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

Other Identifiers

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2023-1405

Identifier Type: -

Identifier Source: org_study_id

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