Management of Retained Placenta With the "Windmill" Technique of Umbilical Cord Traction

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    70
  • sponsor
    Charite University, Berlin, Germany
Updated on 23 January 2021

Summary

The incidence of leftover placenta after vaginal delivery is between 0.1% and 3.3%, with a maternal mortality of up to 10% reported. The traditional management is ultimately the manual removal of the retained placenta (MROP) in the operating room. However, MROP itself increases the risk of further bleeding, postpartum infection, uterine perforation and inversion of the uterus. In a preliminary study with a small cohort, the "Windmill Technique" has already been successfully tested.

Description

The Windmill technique of placenta development for the management of the retained placenta involves the application of a continuous 360-degree umbilical traction force with centripetal rotation in such a way that it runs at the level of the introitus perpendicular to the direction of the birth canal.

The aim of this prospective randomized study is to compare the Windmill placental development technique with traditional placental development strategies. It also analyzes the need to carry out MROP in both groups.

The primary objective of the study is to compare the success rate of removing the placenta in retained placenta pregnancies between the Windmill technique and the control group. Based on this objective, we expected the difference of success rate between groups of 30% (from the previous study, the success rate of the Windmill technique was 86%]. The sample size of 35 participants per group will be required to provide 90% power at a 0.05 two-sided significance level.

Details
Condition Placenta; Retention, Placenta; Retention, Placenta; Retention
Treatment Windmill at 30 Minutes, Windmill at 45 Minutes
Clinical Study IdentifierNCT04000321
SponsorCharite University, Berlin, Germany
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Presence of the written consent of the patient
The patients must be over 18 years old
Patients are not limited in their ability to consent

Exclusion Criteria

Age under 18
Limited ability to work
Known coagulation disorder
Blood loss> 500ml
Known placenta accreta
No extension of the umbilical cord on traction
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