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

Charité University Medicine Berlin

Status: Enrolling

Conditions: Placenta; Retention

Treatments: Other: Windmill at 45 Minutes; Other: Windmill at 30 Minutes

Study type: Interventional

Funder types: Other

Identifiers

NCT04000321

EA1/037/19

Details and patient eligibility

About

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 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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Windmill group 30 Mins

Experimental group

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.

Treatment:

Other: Windmill at 30 Minutes

Control Group

Active Comparator group

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.

Treatment:

Other: Windmill at 45 Minutes