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OpenTrials
Completed

NCT Number: NCT06201910

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Goethe University, Frankfurt am Main, Hesse, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnancy

Exclusion criteria

  • pre-existing coagulation disorder

Treatment and study plan

Observation of Blood loss

Other

Retrospetive observation of bloodloss and RBC transfusions.

Primary outcomes

  1. Bloodloss

    Time frame: Within the first 24 hours after delivery

    Blood loss measured by haemoglobin value

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

Retrospective Evaluation of Peripartum Blood Loss and Postpartum Anaemia With Respect to Fetal Macrosomia and Gemini

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 11, 2024
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.