Complete Placenta PreviaPhase 2NCT02695069
Efficacy Study of Random Placenta Margin Incision to Treat Complete Placenta Previa
A Phase 2 study testing Random Placenta Margin Incision in people with Complete Placenta Previa, run by Maternal and Child Health Hospital of Foshan at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy of random placenta margin incision for hemorrhage control during cesarean section of complete placenta previa pregnancies. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complete Placenta Previa
- What is being tested?
- Random Placenta Margin Incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Apr 2017
- Phase
- Phase 2
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A gestation age of ≥ 28 weeks
- Delivered by cesarean section
- Antepartum diagnosis of complete placenta accreta by obstetric ultrasound and doppler
Who cannot join
- Women who refuse to participate
- Pregnant women with serious diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Maternal and Child Health Hospital of Foshan
Foshan, Guangdong, 528000
About this study
Official title: Random Placenta Margin Incision for Hemorrhage Control During Cesarean Section of Complete Placenta Previa Pregnancies
The purpose of this study is to assess the efficacy of random placenta margin incision for hemorrhage control during cesarean section of complete placenta previa pregnancies.
Read the detailed description
Placenta previa is used to describe a placenta that is implanted over or very near the internal cervical os and the complete placenta previa is defined that the internal os is covered completely by placenta. This obstetric complication is associated with high risks for maternal hemorrhage and emergency peripartum hysterectomy can be the only effective action to take, although it carries many morbidities for the women especially those with low parity. Although, nowadays the obstetrician can diagnose placenta previa before delivery, it is still one of the important causes of maternal mortality. The only safe and appropriate mode of delivery for placenta previa is by cesarean delivery. In the absence of accreta, this can usually be accomplished using a lower segment uterine incision. Because of cutting through the placenta, it is often associated with increased maternal bleeding. In addition, the umbilical cord will be also excessive blood loss when the placenta is transected. Theoretically, random placenta margin incision can effectively avoid the damage of the placenta and reduce the maternal blood loss.
The investigators conduct a prospective study to assess the efficacy of random placenta margin incision for hemorrhage control during cesarean section of complete placenta previa pregnancies at Department of Obstetrics, Southern Medical University Affiliated Maternal and Child Health Hospital of Foshan, since January 2016 till December 2016, after approval of the study protocol by the Local Ethical Committee.
All participants have complete placenta previa and provide written informed consent to undergo any procedure necessary as an attempt to avoid hysterectomy. And they also provide written informed consent to undergo hysterectomy if all measures attempted to preserve the uterus fail.
To precisely determine the placental location and the edge of the placenta, preoperative ultrasonography is used in determining the optimal place for the uterine incision. The investigator performed all cesarean deliveries and assisted by the second investigator. The parietal peritoneum is opened by sharp dissection and blunt expansion, if necessary, high above the bladder, a bladder flap is made and the bladder is retracted. A random hysterotomy incision is done in the placenta margin. It is expanded on both sides using scissors, stopping shortly before the uterine arteries. Active delivery of the placenta is attempted by searching manually for a plane of cleavage between the placenta and the uterus after delivery of the fetus. In addition to uterotonics, measures such as "oversewing" of the placental bed, intrauterine balloon tamponade, and B-Lynch or other compression sutures are also used depending on different circumstances.
- Conditions
- Complete Placenta Previa
- Being tested
- Random Placenta Margin Incision
- Keywords
- Complete Placenta Previa, Random Placenta Margin Incision, Cesarean Section, Hemorrhage
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Random Placenta Margin IncisionProcedure or surgery
A random hysterotomy incision is done in the placenta margin. To precisely determine the placental location and the edge of the placenta, preoperative ultrasonography is used in determining the optimal place for the uterine incision.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | A random hysterotomy incision is done in the placenta margin. To precisely determine the placental location and the edge of the placenta, preoperative ultrasonography is used in determining the optimal place for the uterine incision. Receives: Procedure: Random Placenta Margin Incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Hemorrhage
Measured: within the first 30 days after cesarean section
Secondary outcomes (2)
Number of blood products transfused
Measured: within the first 30 days after cesarean section
Length of hospitalization
Measured: 6 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete Placenta PreviaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maternal and Child Health Hospital of Foshan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengping Liu, MD, Maternal and Child Health Hospital of Foshan
- Investigators
- Zhengping Liu, MD, Principal investigator, Maternal and Child Health Hospital of Foshan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695069
- Sponsor's protocol ID
- MCHHFoshan-1601
- Status last verified
- Nov 2017
- First submitted
- 22 Feb 2016
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Random Placenta Margin Incision for Hemorrhage Control During Cesarean Section of Complete Placenta Previa Pregnancies
- ClinicalTrials.gov ID
- NCT02695069
- Acronym / sponsor ID
- MCHHFoshan-1601
- Conditions
- Complete Placenta Previa
- Keywords
- Complete Placenta Previa, Random Placenta Margin Incision, Cesarean Section, Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Maternal and Child Health Hospital of FoshanUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 1 Mar 2016 (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 assess the efficacy of random placenta margin incision for hemorrhage control during cesarean section of complete placenta previa pregnancies.
Detailed description
Placenta previa is used to describe a placenta that is implanted over or very near the internal cervical os and the complete placenta previa is defined that the internal os is covered completely by placenta. This obstetric complication is associated with high risks for maternal hemorrhage and emergency peripartum hysterectomy can be the only effective action to take, although it carries many morbidities for the women especially those with low parity. Although, nowadays the obstetrician can diagnose placenta previa before delivery, it is still one of the important causes of maternal mortality. The only safe and appropriate mode of delivery for placenta previa is by cesarean delivery. In the absence of accreta, this can usually be accomplished using a lower segment uterine incision. Because of cutting through the placenta, it is often associated with increased maternal bleeding. In addition, the umbilical cord will be also excessive blood loss when the placenta is transected. Theoretically, random placenta margin incision can effectively avoid the damage of the placenta and reduce the maternal blood loss.
The investigators conduct a prospective study to assess the efficacy of random placenta margin incision for hemorrhage control during cesarean section of complete placenta previa pregnancies at Department of Obstetrics, Southern Medical University Affiliated Maternal and Child Health Hospital of Foshan, since January 2016 till December 2016, after approval of the study protocol by the Local Ethical Committee.
All participants have complete placenta previa and provide written informed consent to undergo any procedure necessary as an attempt to avoid hysterectomy. And they also provide written informed consent to undergo hysterectomy if all measures attempted to preserve the uterus fail.
To precisely determine the placental location and the edge of the placenta, preoperative ultrasonography is used in determining the optimal place for the uterine incision. The investigator performed all cesarean deliveries and assisted by the second investigator. The parietal peritoneum is opened by sharp dissection and blunt expansion, if necessary, high above the bladder, a bladder flap is made and the bladder is retracted. A random hysterotomy incision is done in the placenta margin. It is expanded on both sides using scissors, stopping shortly before the uterine arteries. Active delivery of the placenta is attempted by searching manually for a plane of cleavage between the placenta and the uterus after delivery of the fetus. In addition to uterotonics, measures such as "oversewing" of the placental bed, intrauterine balloon tamponade, and B-Lynch or other compression sutures are also used depending on different circumstances.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Procedure: Random Placenta Margin IncisionA random hysterotomy incision is done in the placenta margin. To precisely determine the placental location and the edge of the placenta, preoperative ultrasonography is used in determining the optimal place for the uterine incision. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A gestation age of ≥ 28 weeks
- Delivered by cesarean section
- Antepartum diagnosis of complete placenta accreta by obstetric ultrasound and doppler
Key exclusion criteria (2 listed)
- Women who refuse to participate
- Pregnant women with serious diseases
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 |
|---|---|---|
| Random Placenta Margin IncisionA random hysterotomy incision is done in the placenta margin. To precisely determine the placental location and the edge of the placenta, preoperative ultrasonography is used in determining the optimal place for the uterine incision. | Procedure or surgery | All Participants |
Primary outcome
Postpartum Hemorrhage
Time frame: within the first 30 days after cesarean section
2 secondary outcomes
Number of blood products transfused
Time frame: within the first 30 days after cesarean section
Length of hospitalization
Time frame: 6 months after delivery
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 13 Nov 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Complete Placenta Previa
Not yet recruitingObservational study
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
Placenta Accreta Spectrum, Placenta Previa
Not yet recruiting
Accuracy of Rail Sign at Detection of PAS
Placenta Previa Complete Centralis
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.
Zhengping Liu, MD principal investigator
Maternal and Child Health Hospital of Foshan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Random Placenta Margin Incision in people with Complete Placenta Previa, run by Maternal and Child Health Hospital of Foshan at 1 site in China.
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: finished, as of the sponsor's last update on 13 Nov 2017. 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postpartum Hemorrhage (time frame: within the first 30 days after cesarean section). 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 13 Nov 2017.