Management of Retained Placenta With the “Windmill” Technique of Umbilical Cord Traction

Overview

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.

Full Title of Study: “Management of Retained Placenta With Circular Cord Traction for Placenta Delivery- the “Windmill” Technique of Umbilical Cord Traction”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2021

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Delivery of the placenta
    • Time Frame: At the end of delivery
    • Successful delivery of the placenta

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Charite University, Berlin, Germany
  • Provider of Information About this Clinical Study
    • Principal Investigator: Larry Hinkson, Lead Consultant Obstetrics – Charite University, Berlin, Germany
  • Overall Contact(s)
    • Larry Hinkson, 004930450664710, Larry.Hinkson@charite.de

References

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.

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