Placenta AccretaPDIUCNCT03273569
PDIUC Protocol for Placental Accreta
A study testing PDI-UC protocol in people with Placenta Accreta, run by Assiut University.
Trial summary
The aim of this study is to evaluate a novel protocol to conserve the uterus during Cesarean delivery indicated for placenta accreta. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- PDI-UC protocol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to 1 Jun 2018
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with diagnosis of placenta accreta (US or MRI based diagnosis)
- Women who decline hysterectomy
- Pregnancy at 28 weeks of gestation or beyond
- Women who accept to participate in the study
Who cannot join
- Emergency Cesarean delivery (women with active bleeding)
- Women with cardiac diseases
- Women with coagulopathy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Preplacental Delivery Intervention for Uterine Conservation Protocol: a Novel Approach for Management of Placenta Accreta
The aim of this study is to evaluate a novel protocol to conserve the uterus during Cesarean delivery indicated for placenta accreta.
Read the detailed description
Placenta accreta is a morbid obstetric condition that describes variable non-physiologic invasion of the placenta into the the uterine wall. The incidence of placenta accreta, as a serious cause of postpartum hemorrhage, has substantially increased secondary to increase the rate of Cesarean delivery. Placenta accreta is primarily managed by peripartum hysterectomy prior to delivery of the placenta to avoid uncontrolled bleeding. However, in addition to the surgical risks, hysterectomy is psychologically morbid to many women particularly younger women and women with low parity. Therefore, several conservative options were studied to provide an alternative for hysterectomy in these women. Our study is designated to evaluate a proposed protocol of multi-step interventions to reduce the anticipated amount of bleeding prior to delivery of the placenta.
- Conditions
- Placenta Accreta
- Being tested
- PDI-UC protocol
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDI-UC protocolProcedure or surgery
Preplacental delivery intervention for uterine conservation protocol starts after delivery of the fetus during Cesarean delivery and consists of delayed cord clamping, intramyometrial injection of vasopressin, subdecidual injection of saline, ligation of the uterine arteries, multiple 8 compression sutures, followed by delivery of the placenta, application of pressure and interrupted sutures if needed
| Study group | Role | What they receive |
|---|---|---|
| Women with placenta accreta | Experimental | PDI-UC protocol Receives: Procedure: PDI-UC protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine conservation
Successive Uterine conservation; no peripartum hysterectomy needed
Measured: Intra-operative (during the time of Cesarean delivery)
Secondary outcomes (6)
Primary postpartum hemorrhage
Amount of postpartum bleeding > 1000 ml
Measured: From delivery of the fetus to 1 hour after delivery of the fetus
Severe primary postpartum hemorrhage
Amount of postpartum bleeding > 1500 ml
Measured: From delivery of the fetus to 1 hour after delivery of the fetus
Bladder injury
Incidental injury of the bladder during delivery of the placenta or control of bleeding
Measured: Intra-operative (during the time of Cesarean delivery)
Bowel injury
Incidental injury of the bladder during delivery of the placenta or control of bleeding
Measured: Intra-operative (during the time of Cesarean delivery)
Surgical site infection
Cesarean wound infection
Measured: Up to 2 weeks after Cesarean delivery
Drop in hemoglobin level
Change in hemoglobin before and more than 24 hours after delivery
Measured: Hemoglobin is checked 1 hour prior to Cesarean delivery and again postoperative (24 and 72 hours after Cesarean delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start1 Oct 2017 (estimated)
- Primary completion30 Mar 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Women with placenta accreta at the time of Cesarean delivery
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Abdelkarim Mohammed Shazly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273569
- Sponsor's protocol ID
- PDIUC001
- Acronym
- PDIUC
- Status last verified
- Sep 2017
- First submitted
- 5 Aug 2017
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preplacental Delivery Intervention for Uterine Conservation Protocol: a Novel Approach for Management of Placenta Accreta
- ClinicalTrials.gov ID
- NCT03273569
- Acronym / sponsor ID
- PDIUC / PDIUC001
- Conditions
- Placenta Accreta
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 30 Mar 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 6 Sep 2017 (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 aim of this study is to evaluate a novel protocol to conserve the uterus during Cesarean delivery indicated for placenta accreta.
Detailed description
Placenta accreta is a morbid obstetric condition that describes variable non-physiologic invasion of the placenta into the the uterine wall. The incidence of placenta accreta, as a serious cause of postpartum hemorrhage, has substantially increased secondary to increase the rate of Cesarean delivery. Placenta accreta is primarily managed by peripartum hysterectomy prior to delivery of the placenta to avoid uncontrolled bleeding. However, in addition to the surgical risks, hysterectomy is psychologically morbid to many women particularly younger women and women with low parity. Therefore, several conservative options were studied to provide an alternative for hysterectomy in these women. Our study is designated to evaluate a proposed protocol of multi-step interventions to reduce the anticipated amount of bleeding prior to delivery of the placenta.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Women with placenta accreta at the time of Cesarean delivery
| Arm | Type | Receives |
|---|---|---|
| Women with placenta accreta | Experimental | Procedure: PDI-UC protocolPDI-UC protocol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women with diagnosis of placenta accreta (US or MRI based diagnosis)
- Women who decline hysterectomy
- Pregnancy at 28 weeks of gestation or beyond
- Women who accept to participate in the study
Key exclusion criteria (3 listed)
- Emergency Cesarean delivery (women with active bleeding)
- Women with cardiac diseases
- Women with coagulopathy
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 |
|---|---|---|
| PDI-UC protocolPreplacental delivery intervention for uterine conservation protocol starts after delivery of the fetus during Cesarean delivery and consists of delayed cord clamping, intramyometrial injection of vasopressin, subdecidual injection of saline, ligation of the uterine arteries, multiple 8 compression sutures, followed by delivery of the placenta, application of pressure and interrupted sutures if needed | Procedure or surgery | Women with placenta accreta |
Primary outcome
Uterine conservation
Time frame: Intra-operative (during the time of Cesarean delivery)
Successive Uterine conservation; no peripartum hysterectomy needed
6 secondary outcomes
Primary postpartum hemorrhage
Time frame: From delivery of the fetus to 1 hour after delivery of the fetus
Severe primary postpartum hemorrhage
Time frame: From delivery of the fetus to 1 hour after delivery of the fetus
Bladder injury
Time frame: Intra-operative (during the time of Cesarean delivery)
Bowel injury
Time frame: Intra-operative (during the time of Cesarean delivery)
Surgical site infection
Time frame: Up to 2 weeks after Cesarean delivery
Drop in hemoglobin level
Time frame: Hemoglobin is checked 1 hour prior to Cesarean delivery and again postoperative (24 and 72 hours after Cesarean delivery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing PDI-UC protocol in people with Placenta Accreta, run by Assiut University.
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 4 inclusion and 3 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 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Sherif Shazly, MBBCh, MSc (+15075131392, sherify2k2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine conservation (time frame: Intra-operative (during the time of 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 6 Sep 2017.