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

NCT ID: NCT04000321

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-13
• Study Completion Date: 2025-12-31

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.

Conditions

Placenta; Retention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Windmill at 30 Minutes

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Windmill at 45 Minutes

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Larry Hinkson

Lead Consultant Obstetrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charité University Hospital

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Larry Hinkson

Role: CONTACT

Larry.Hinkson@charite.de

004930450664710

Facility Contacts

Larry Hinkson, FRCOG

Role: primary

Larry.Hinkson@charite.de

0049030450664710

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.

Reference Type: BACKGROUND

PMID: 28591673 (View on PubMed)

Other Identifiers

EA1/037/19

Identifier Type: -

Identifier Source: org_study_id