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

Not Applicable

Recruiting

• Conditions: Placenta; Retention
• Interventions: Other: Windmill at 30 Minutes; Other: Windmill at 45 Minutes

• Registration Number: NCT04000321
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2019-06-13
• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Windmill group 30 Mins	Windmill at 30 Minutes	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.
Control Group	Windmill at 45 Minutes	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.

Primary Outcome Measures

Name	Time	Method
Delivery of the placenta	At the end of delivery	Successful delivery of the placenta

Secondary Outcome Measures

Name	Time	Method
Need for Manual Removal of Placenta	At the end of delivery	Operative manual removal of placenta
Blood loss	At the end of delivery	Estimated and Calculated Blood Loss

Trial Locations

Locations (1)

Charité University Hospital; 🇩🇪 Berlin, Germany