Placenta; RetentionWindmillNCT04000321
Management of Retained Placenta With the "Windmill" Technique of Umbilical Cord Traction
A study testing Windmill at 30 Minutes and Windmill at 45 Minutes in people with Placenta; Retention, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta; Retention
- What is being tested?
- Windmill at 30 Minutes and Windmill at 45 Minutes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 13 Jun 2019to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité University Hospital
Berlin, 10117
Larry Hinkson, FRCOG, 0049030450664710, Larry.Hinkson@charite.de
About this study
Official title: Management of Retained Placenta With Circular Cord Traction for Placenta Delivery- the "Windmill" Technique of Umbilical Cord Traction
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.
Read the 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
- Being tested
- Windmill at 30 Minutes, Windmill at 45 Minutes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Windmill at 30 MinutesOther
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.
Windmill at 45 MinutesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Windmill group 30 Mins | Experimental | 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. Receives: Other: Windmill at 30 Minutes |
| Control Group | Active comparator | 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. Receives: Other: Windmill at 45 Minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery of the placenta
Successful delivery of the placenta
Measured: At the end of delivery
Secondary outcomes (2)
Need for Manual Removal of Placenta
Operative manual removal of placenta
Measured: At the end of delivery
Blood loss
Estimated and Calculated Blood Loss
Measured: At the end of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start13 Jun 2019
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Placenta; RetentionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larry Hinkson, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000321
- Sponsor's protocol ID
- EA1/037/19
- Acronym
- Windmill
- Status last verified
- Feb 2024
- First submitted
- 13 Jun 2019
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28591673
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Retained Placenta With Circular Cord Traction for Placenta Delivery- the "Windmill" Technique of Umbilical Cord Traction
- ClinicalTrials.gov ID
- NCT04000321
- Acronym / sponsor ID
- Windmill / EA1/037/19
- Conditions
- Placenta; Retention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Windmill group 30 Mins | Experimental | Other: Windmill at 30 MinutesIn 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. |
| Control Group | Active comparator | Other: Windmill at 45 MinutesIn 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Age under 18
- Limited ability to work
- Known coagulation disorder
- Blood loss> 500ml
- Known placenta accreta
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Windmill at 30 MinutesThe 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 group 30 Mins |
| Windmill at 45 MinutesThe 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 | Control Group |
Primary outcome
Delivery of the placenta
Time frame: At the end of delivery
Successful delivery of the placenta
2 secondary outcomes
Need for Manual Removal of Placenta
Time frame: At the end of delivery
Blood loss
Time frame: At the end of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 28591673Hinkson 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Windmill at 30 Minutes and Windmill at 45 Minutes in people with Placenta; Retention, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Larry Hinkson (004930450664710, Larry.Hinkson@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery of the placenta (time frame: At the end of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04000321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.