Clinical trial NCT04000321: Management of Retained Placenta With the "Windmill" Technique of Umbilical Cord Traction
Official title: Management of Retained Placenta With Circular Cord Traction for Placenta Delivery- the "Windmill" Technique of Umbilical Cord Traction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Placenta; Retention
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Delivery of the placenta
timeFrame: At the end of delivery
Secondary outcomes:
measure: Need for Manual Removal of Placenta
timeFrame: At the end of delivery
measure: Blood loss
timeFrame: At the end of delivery
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Hospital
Study officials:
References:
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.