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

Placenta; Retention Clinical Trial

— Windmill  

Official title:

Management of Retained Placenta With Circular Cord Traction for Placenta Delivery- the "Windmill" Technique of Umbilical Cord Traction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04000321
• Other study ID #: EA1/037/19
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: Larry Hinkson
• Phone: 004930450664710
• Email: Larry.Hinkson[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Placenta, Retained
• Placenta; Retention

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Charité University Hospital	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delivery of the placenta	Successful delivery of the placenta	At the end of delivery
Secondary	Need for Manual Removal of Placenta	Operative manual removal of placenta	At the end of delivery
Secondary	Blood loss	Estimated and Calculated Blood Loss	At the end of delivery