Placenta; Retention
Conditions
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.
Interventions
OTHERWindmill 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.
OTHERWindmill 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.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking 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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delivery of the placenta | At the end of delivery | Successful delivery of the placenta |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Contacts
Primary ContactLarry Hinkson
Outcome results
None listed