Placenta Previa Complete CentralisPhase 2/3PPHNCT02157441
the Treatment of Postpartum Hemorrhage Due to Placenta Previa Complete Centralis
A Phase 2/3 study testing lower uterine compression sutures in people with Placenta Previa Complete Centralis, run by Benha University at 1 site in Egypt.
Trial summary
Objective: To assess the efficacy of lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete… Read more about this study
- Who is it for?
- Ages 21 to 46 years, women only
- Conditions the study is for
- Placenta Previa Complete Centralis
- What is being tested?
- lower uterine compression sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2012to Sep 2015
- Phase
- Phase 2/3
- 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 21 to 46 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- a gestation age of ≥ 28 weeks and antepartum hemorrhage;
- intraoperative postpartum hemorrhage and discovery of a placenta previa;
- successful removal of the placenta
Who cannot join
- shock due to massive blood loss
- failure of successful removal of the placenta
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lower Uterine Compression Sutures for the Treatment of Postpartum Hemorrhage Due to Placenta Previa Complete Centralis; Prospective Study
Objective: To assess the efficacy of lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis. Method: This prospective study of 50 women with postpartum hemorrhage following removal of placenta previa complete centralis during elective cesarean section. All 50 patients will have lower uterine compression sutures (involving bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch). All patients will be followed postpartum for evaluation of uterine cavity and menstrual cycles
Read the detailed description
The investigators conduct a prospective study at Department of Obstetrics and Gynecology, Benha University Hospital, since June 2012 till July 2014, after approval of the study protocol by the Local Ethical Committee.
All patients provide written informed consent to undergo any procedure necessary, including lower uterine compression suturing procedure, as an attempt to avoid hysterectomy. They also provide written informed consent to undergo hysterectomy if all measures attempted to preserve the uterus fail.
All patients have placenta previa (50). The inclusion criteria are a gestation age of ≥ 28 weeks and antepartum hemorrhage; intraoperative postpartum hemorrhage and discovery of a placenta accreta; and an adherent placental part after piecemeal removal of the placenta, with bleeding from the placental site, posterior placenta previa and/or successful piecemeal removal of the placenta.
The first author performed all cesarean deliveries and assisted by the second author. We open the parietal peritoneum by sharp dissection and blunt expansion, high above the bladder, a bladder flap is made and the bladder is retracted. A small median transverse hysterotomy incision is done in the lower uterine segment. 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. The study technique comprise lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch).
- Conditions
- Placenta Previa Complete Centralis
- Being tested
- lower uterine compression sutures
- Keywords
- Postpartum Hemorrhage, Placenta Previa, uterine cavity
- Medical subject headings
- Postpartum Hemorrhage, Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower uterine compression suturesProcedure or surgery
intervention is lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis.
| Study group | Role | What they receive |
|---|---|---|
| all patients | Experimental | intervention is lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis. Receives: Procedure: lower uterine compression sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of Postpartum Hemorrhage
Measured: during cesarean section( participants will be followed for the duration of hospital stay)
Secondary outcomes (1)
evaluation of uterine cavity
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 posted6 Jun 2014 (estimated)
- Study startJul 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Previa Complete CentralisStudies of the same condition, open and under way.
- More trials run by Benha 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khalid abd aziz mohamed, Benha University
- Investigators
- khalid mohamed, MD, Study chair, Department of Obstetrics and Gynecology, Benha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157441
- Sponsor's protocol ID
- khalid-ahmed 4
- Acronym
- PPH
- Status last verified
- Oct 2015
- First submitted
- 3 Jun 2014
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Uterine Compression Sutures for the Treatment of Postpartum Hemorrhage Due to Placenta Previa Complete Centralis; Prospective Study
- ClinicalTrials.gov ID
- NCT02157441
- Acronym / sponsor ID
- PPH / khalid-ahmed 4
- Conditions
- Placenta Previa Complete Centralis
- Keywords
- Postpartum Hemorrhage, Placenta Previa, uterine cavity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Jun 2014 (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.
Objective: To assess the efficacy of lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis. Method: This prospective study of 50 women with postpartum hemorrhage following removal of placenta previa complete centralis during elective cesarean section. All 50 patients will have lower uterine compression sutures (involving bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch). All patients will be followed postpartum for evaluation of uterine cavity and menstrual cycles
Detailed description
The investigators conduct a prospective study at Department of Obstetrics and Gynecology, Benha University Hospital, since June 2012 till July 2014, after approval of the study protocol by the Local Ethical Committee.
All patients provide written informed consent to undergo any procedure necessary, including lower uterine compression suturing procedure, as an attempt to avoid hysterectomy. They also provide written informed consent to undergo hysterectomy if all measures attempted to preserve the uterus fail.
All patients have placenta previa (50). The inclusion criteria are a gestation age of ≥ 28 weeks and antepartum hemorrhage; intraoperative postpartum hemorrhage and discovery of a placenta accreta; and an adherent placental part after piecemeal removal of the placenta, with bleeding from the placental site, posterior placenta previa and/or successful piecemeal removal of the placenta.
The first author performed all cesarean deliveries and assisted by the second author. We open the parietal peritoneum by sharp dissection and blunt expansion, high above the bladder, a bladder flap is made and the bladder is retracted. A small median transverse hysterotomy incision is done in the lower uterine segment. 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. The study technique comprise lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients | Experimental | Procedure: lower uterine compression suturesintervention is lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis. |
Who may qualify
- Ages
- 21 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- a gestation age of ≥ 28 weeks and antepartum hemorrhage;
- intraoperative postpartum hemorrhage and discovery of a placenta previa;
- successful removal of the placenta
Key exclusion criteria (2 listed)
- shock due to massive blood loss
- failure of successful removal of the placenta
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 |
|---|---|---|
| lower uterine compression suturesintervention is lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis. | Procedure or surgery | all patients |
Primary outcome
Treatment of Postpartum Hemorrhage
Time frame: during cesarean section( participants will be followed for the duration of hospital stay)
1 secondary outcome
evaluation of uterine cavity
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 14 Oct 2015.
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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.
khalid mohamed, MD study chair
Department of Obstetrics and Gynecology, Benha University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing lower uterine compression sutures in people with Placenta Previa Complete Centralis, run by Benha University at 1 site in Egypt.
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 14 Oct 2015. 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 Egypt. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Treatment of Postpartum Hemorrhage (time frame: during cesarean section( participants will be followed for the duration of hospital stay)). 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 Oct 2015.