PregnancyNCT00375986
A Comparison of Manual vs. Spontaneous Removal of the Placenta at Cesarean Section
A study testing Manual placental removal at Cesarean delivery and Spontaneous placental removal at Cesarean delivery in people with Pregnancy and Cesarean Section, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to determine if there are differences in operative blood loss with manual vs. spontaneous removal of the placenta during cesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Cesarean Section
- What is being tested?
- Manual placental removal at Cesarean delivery and Spontaneous placental removal at Cesarean delivery
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jun 2007
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All term pregnant women 18 years of age and older undergoing scheduled cesarean delivery at Strong Memorial Hospital.
Who cannot join
- Prematurity (<37 weeks)
- Preoperative chorioamnionitis
- Vaginal delivery of fetus
- Emergency Cesarean Delivery
- Patient's OB not agreeable to participating in this study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if there are differences in operative blood loss with manual vs. spontaneous removal of the placenta during cesarean section.
Read the detailed description
Patients undergoing scheduled cesarean deliveries are randomized to manual or spontaneous placental removal.
- Conditions
- Pregnancy, Cesarean Section
- Being tested
- Manual placental removal at Cesarean delivery, Spontaneous placental removal at Cesarean delivery
- Keywords
- Cesarean delivery, Placental removal, Blood loss
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual placental removal at Cesarean deliveryProcedure or surgery
Spontaneous placental removal at Cesarean deliveryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematocrit levels (preoperatively and within 48 hours postoperatively)
Secondary outcomes (4)
Number of units of blood transfused intraoperatively and postoperatively
Development of uterine infection (endometritis)
Length of postoperative hospital stay
Operative time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startSep 2006
- Study completionJun 2007
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.
- More trials run by University of RochesterThe 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Investigators
- Eva K. Pressman, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375986
- Sponsor's protocol ID
- 00014248
- Status last verified
- Nov 2007
- First submitted
- 11 Sep 2006
- Last updated
- 14 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Manual vs. Spontaneous Removal of the Placenta at Cesarean Section
- ClinicalTrials.gov ID
- NCT00375986
- Acronym / sponsor ID
- 00014248
- Conditions
- Pregnancy, Cesarean Section
- Keywords
- Cesarean delivery, Placental removal, Blood loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 13 Sep 2006 (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 determine if there are differences in operative blood loss with manual vs. spontaneous removal of the placenta during cesarean section.
Detailed description
Patients undergoing scheduled cesarean deliveries are randomized to manual or spontaneous placental removal.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All term pregnant women 18 years of age and older undergoing scheduled cesarean delivery at Strong Memorial Hospital.
Key exclusion criteria (5 listed)
- Prematurity (<37 weeks)
- Preoperative chorioamnionitis
- Vaginal delivery of fetus
- Emergency Cesarean Delivery
- Patient's OB not agreeable to participating in this study.
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 placental removal at Cesarean delivery | Procedure or surgery | – |
| Spontaneous placental removal at Cesarean delivery | Procedure or surgery | – |
Primary outcome
Hematocrit levels (preoperatively and within 48 hours postoperatively)
4 secondary outcomes
Number of units of blood transfused intraoperatively and postoperatively
Development of uterine infection (endometritis)
Length of postoperative hospital stay
Operative time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2007.
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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.
Eva K. Pressman, MD principal investigator
University of Rochester
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 placental removal at Cesarean delivery and Spontaneous placental removal at Cesarean delivery in people with Pregnancy and Cesarean Section, run by University of Rochester 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 14 Nov 2007. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hematocrit levels (preoperatively and within 48 hours postoperatively). 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 14 Nov 2007.