search
Back to results

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

Primary Purpose

Placenta; Retention

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Windmill at 30 Minutes
Windmill at 45 Minutes
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Placenta; Retention

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Charité University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Windmill group 30 Mins

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Delivery of the placenta
Successful delivery of the placenta

Secondary Outcome Measures

Need for Manual Removal of Placenta
Operative manual removal of placenta
Blood loss
Estimated and Calculated Blood Loss

Full Information

First Posted
June 13, 2019
Last Updated
September 5, 2019
Sponsor
Charite University, Berlin, Germany
search

1. Study Identification

Unique Protocol Identification Number
NCT04000321
Brief Title
Management of Retained Placenta With the "Windmill" Technique of Umbilical Cord Traction
Acronym
Windmill
Official Title
Management of Retained Placenta With Circular Cord Traction for Placenta Delivery- the "Windmill" Technique of Umbilical Cord Traction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta; Retention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Windmill group 30 Mins
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Windmill at 30 Minutes
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Windmill at 45 Minutes
Intervention Description
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 Measure Information:
Title
Delivery of the placenta
Description
Successful delivery of the placenta
Time Frame
At the end of delivery
Secondary Outcome Measure Information:
Title
Need for Manual Removal of Placenta
Description
Operative manual removal of placenta
Time Frame
At the end of delivery
Title
Blood loss
Description
Estimated and Calculated Blood Loss
Time Frame
At the end of delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Larry Hinkson
Phone
004930450664710
Email
Larry.Hinkson@charite.de
Facility Information:
Facility Name
Charité University Hospital
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larry Hinkson, FRCOG
Phone
0049030450664710
Email
Larry.Hinkson@charite.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28591673
Citation
Hinkson L, Suermann MA, Hinkson S, Henrich W. The Windmill technique avoids manual removal of the retained placenta-A new solution for an old problem. Eur J Obstet Gynecol Reprod Biol. 2017 Aug;215:6-11. doi: 10.1016/j.ejogrb.2017.05.028. Epub 2017 Jun 1.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs