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

May 5, 2025 updated by: Armin N. Flinspach, Goethe University

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

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

575

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • University Hospital Frankfurt
      • Frankfurt, Hessen, Germany, 60598
        • Goethe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant women with or without twin pregnancies or macrosomere singletons

Description

Inclusion Criteria:

  • Pregnancy

Exclusion Criteria:

  • pre-existing coagulation disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

February 1, 2025

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

March 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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