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

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ClinicalTrials.gov Identifier: NCT04000321
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Larry Hinkson, Charite University, Berlin, Germany

Brief 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.

Condition or disease Intervention/treatment Phase
Placenta; Retention Other: Windmill at 30 Minutes Other: Windmill at 45 Minutes Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The primary objective of the study is to compare the success rate of removing the placenta in retained placenta pregnencies 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.
Masking: None (Open Label)
Masking Description: The primary objective of the study is to compare the success rate of removing the placenta in retained placenta pregnencies 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.
Primary Purpose: Treatment
Official Title: Management of Retained Placenta With Circular Cord Traction for Placenta Delivery- the "Windmill" Technique of Umbilical Cord Traction
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Windmill group 30 Mins
In the Windmill Group, the Windmill technique is carried out after 30 minutes. The windmill technique of the umbilical cord for placental development is performed by a trained obstetrician or midwife with a doctor presence. In a frustrated attempt to develop placenta using the Windmill technique, a manual removal is performed according to the clinic standard.
Other: Windmill at 30 Minutes
The so-called 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. This rotation around a 360-degree traction plane is repeated slowly and continuously with a motion that resembles the motion of the wings of a windmill until the placenta can be safely delivered.

Active Comparator: Control Group
In the control group, after a total of 45 minutes of unsuccessful application of the traditional and customary measures, the Windmill technique is used. If unsuccessful, a manual placenta removal is performed according to hospital Standards.
Other: Windmill at 45 Minutes
The so-called 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. This rotation around a 360-degree traction plane is repeated slowly and continuously with a motion that resembles the motion of the wings of a windmill until the placenta can be safely delivered.




Primary Outcome Measures :
  1. Delivery of the placenta [ Time Frame: At the end of delivery ]
    Successful delivery of the placenta


Secondary Outcome Measures :
  1. Need for Manual Removal of Placenta [ Time Frame: At the end of delivery ]
    Operative manual removal of placenta

  2. Blood loss [ Time Frame: At the end of delivery ]
    Estimated and Calculated Blood Loss



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000321


Contacts
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Contact: Larry Hinkson 004930450664710 Larry.Hinkson@charite.de

Locations
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Germany
Charité University Hospital Recruiting
Berlin, Germany, 10117
Contact: Larry Hinkson, FRCOG    0049030450664710    Larry.Hinkson@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany

Publications:
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Responsible Party: Larry Hinkson, Lead Consultant Obstetrics, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04000321     History of Changes
Other Study ID Numbers: EA1/037/19
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Placenta, Retained
Placenta Diseases
Pregnancy Complications