PregnancyNCT00711451
Manual and Expressed Placental Removal at Cesarean Delivery and Its Effects on Various Cardiac Indices
A study testing Manual removal and Expressed removal in people with Pregnancy and Cesarean Delivery, run by Corewell Health East at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether manual removal of the placenta during a cesarean delivery results in higher changes in the resistance of blood flow throughout the body, also called systemic vascular resistance (SVR) Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Cesarean Delivery
- What is being tested?
- Manual removal and Expressed removal
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jan 2012
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant
- scheduled for cesarean delivery
- able to give informed consent
Who cannot join
- taking medications that may affect hemodynamics
- unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Manual and Expressed Placental Removal at Planned Cesarean Delivery and Its Effects on Various Cardiac Indices as Measured By Continuous Wave Doppler Ultrasonography
The purpose of this study is to evaluate whether manual removal of the placenta during a cesarean delivery results in higher changes in the resistance of blood flow throughout the body, also called systemic vascular resistance (SVR)
Read the detailed description
Patients presenting to William Beaumont Hospital Royal Oak Labor and Delivery for a scheduled low transverse cesarean delivery will be asked to participate in a prospective, randomized study to evaluate any changes in systemic vascular resistance (SVR) pre- and post-delivery.
After obtaining informed consent, the patients will be randomized to one of two groups: group 1 will have manual removal of the placenta at cesarean section and group 2 will have expressed removal of the placenta at cesarean section.
Both groups will have a pre-operative continuous wave Doppler evaluation and a post-operative continuous wave Doppler evaluation at 24 hours after delivery. Continuous wave Doppler evaluation will be used pre- and post-operatively to evaluate any changes in SVR.
- Conditions
- Pregnancy, Cesarean Delivery
- Being tested
- Manual removal, Expressed removal
- Keywords
- systemic vascular resistance, pregnancy, scheduled cesarean delivery, syncytiotrophoblast apoptosis, continuous wave Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual removalBehavioural
Also called manual
Manual removal of placenta during cesarean delivery
Expressed removalProcedure or surgery
Also called expressed
Surgeon will perform an expressed delivery of the placenta
| Study group | Role | What they receive |
|---|---|---|
| manual | Active comparator | Manual removal of placenta Receives: Behavioral: Manual removal |
| expressed | Active comparator | expressed placental removal Receives: Procedure: Expressed removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic profile, especially Systemic Vascular Resistance
Measured: immediately before and 24 hours after cesarean delivery
Secondary outcomes (1)
development of postpartum preeclampsia
Measured: within 1 week of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionFeb 2011
- Study completionJan 2012
Why it stopped: unable to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Uckele, Corewell Health East
- Investigators
- Christian Bogner, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711451
- Sponsor's protocol ID
- 2008-056
- Status last verified
- Jul 2012
- First submitted
- 2 Jul 2008
- Last updated
- 16 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual and Expressed Placental Removal at Planned Cesarean Delivery and Its Effects on Various Cardiac Indices as Measured By Continuous Wave Doppler Ultrasonography
- ClinicalTrials.gov ID
- NCT00711451
- Acronym / sponsor ID
- 2008-056
- Conditions
- Pregnancy, Cesarean Delivery
- Keywords
- systemic vascular resistance, pregnancy, scheduled cesarean delivery, syncytiotrophoblast apoptosis, continuous wave Doppler
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to recruit patients
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Jul 2008 (estimated)
- 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 purpose of this study is to evaluate whether manual removal of the placenta during a cesarean delivery results in higher changes in the resistance of blood flow throughout the body, also called systemic vascular resistance (SVR)
Detailed description
Patients presenting to William Beaumont Hospital Royal Oak Labor and Delivery for a scheduled low transverse cesarean delivery will be asked to participate in a prospective, randomized study to evaluate any changes in systemic vascular resistance (SVR) pre- and post-delivery.
After obtaining informed consent, the patients will be randomized to one of two groups: group 1 will have manual removal of the placenta at cesarean section and group 2 will have expressed removal of the placenta at cesarean section.
Both groups will have a pre-operative continuous wave Doppler evaluation and a post-operative continuous wave Doppler evaluation at 24 hours after delivery. Continuous wave Doppler evaluation will be used pre- and post-operatively to evaluate any changes in SVR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manual | Active comparator | Behavioral: Manual removalManual removal of placenta |
| expressed | Active comparator | Procedure: Expressed removalexpressed placental removal |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pregnant
- scheduled for cesarean delivery
- able to give informed consent
Key exclusion criteria (2 listed)
- taking medications that may affect hemodynamics
- unable to give informed consent
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 |
|---|---|---|
| Manual removalAlso: manualManual removal of placenta during cesarean delivery | Behavioural | manual |
| Expressed removalAlso: expressedSurgeon will perform an expressed delivery of the placenta | Procedure or surgery | expressed |
Primary outcome
Hemodynamic profile, especially Systemic Vascular Resistance
Time frame: immediately before and 24 hours after cesarean delivery
1 secondary outcome
development of postpartum preeclampsia
Time frame: within 1 week of delivery
Results and safety
The study was stopped early (reason given: unable to recruit patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
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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.
Christian Bogner, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual removal and Expressed removal in people with Pregnancy and Cesarean Delivery, run by Corewell Health East at 1 site in United States.
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 2 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: stopped early, as of the sponsor's last update on 16 Jul 2012. 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 United States. 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?
The study was stopped early (reason given: unable to recruit patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic profile, especially Systemic Vascular Resistance (time frame: immediately before and 24 hours after cesarean delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2012.