Placenta PreviaNCT03124472
Effect of Uterine Artery Ligation Prior to Uterine Incision in Women With Placenta Previa
A study testing uterine artery ligation and Lower segment Cesarean section in people with Placenta Previa, run by Cairo University at 1 site in Egypt.
Trial summary
Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers. The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Placenta Previa
- What is being tested?
- uterine artery ligation and Lower segment Cesarean section
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients diagnosed with placenta praevia antenatally
- plan is elective caesarean section
- Gestational age >34 weeks
Who cannot join
- Fetal distress
- medical disorders as hypertension or Diabetes Mellitus
- Coagulation defects.
- Emergency Cesarean section
- women with antepartum hemorrhage
- patients with marked ahdesions or those with non possible uterine artery ligation
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy medical school
Cairo, 12151
Ahmed Maged, MD, 01005227404, prof.ahmedmaged@gmail.com
About this study
Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.
- The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.
- Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged.
- Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta Delivery of the baby and placenta.
- Closure of the uterine incision in 2 layers with N0. 1 vicryl suture.
- Closure of the anterior abdominal wall in layers
Read the detailed description
Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.
- The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.
- Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged.
- Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta Delivery of the baby and placenta.
- Closure of the uterine incision in 2 layers with N0. 1 vicryl suture.
- Closure of the anterior abdominal wall in layers In the control group, lower segment caesarean section is without uterine artery ligation
- Conditions
- Placenta Previa
- Being tested
- uterine artery ligation, Lower segment Cesarean section
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterine artery ligationProcedure or surgery
Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged
Lower segment Cesarean sectionProcedure or surgery
Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.
- The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.
Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta Delivery of the baby and placenta.
- Closure of the uterine incision in 2 layers with N0. 1 vicryl suture.
- Closure of the anterior abdominal wall in layers
| Study group | Role | What they receive |
|---|---|---|
| uterine artery ligation | Active comparator | Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.
* The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.
* Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged.
* Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta. Receives: Procedure: uterine artery ligation; Procedure: Lower segment Cesarean section |
| Traditional lower segment Cesarean section | Active comparator | Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.
* The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.
* Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta. Receives: Procedure: Lower segment Cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Hemoglabin level
Measured: 24 hours after Cesarean
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Jun 2017
- Primary completionMay 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PreviaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124472
- Sponsor's protocol ID
- 169
- Status last verified
- Jan 2018
- First submitted
- 19 Apr 2017
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Uterine Artery Ligation Prior to Uterine Incision in Women With Placenta Previa
- ClinicalTrials.gov ID
- NCT03124472
- Acronym / sponsor ID
- 169
- Conditions
- Placenta Previa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 21 Apr 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.
Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.
- The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.
- Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged.
- Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta Delivery of the baby and placenta.
- Closure of the uterine incision in 2 layers with N0. 1 vicryl suture.
- Closure of the anterior abdominal wall in layers
Detailed description
Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.
- The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.
- Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged.
- Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta Delivery of the baby and placenta.
- Closure of the uterine incision in 2 layers with N0. 1 vicryl suture.
- Closure of the anterior abdominal wall in layers In the control group, lower segment caesarean section is without uterine artery ligation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| uterine artery ligation | Active comparator | Procedure: uterine artery ligation, Procedure: Lower segment Cesarean sectionPfannenstiel incision of skin and opening of the anterior abdominal wall in layers. * The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment. * Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged. * Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta. |
| Traditional lower segment Cesarean section | Active comparator | Procedure: Lower segment Cesarean sectionPfannenstiel incision of skin and opening of the anterior abdominal wall in layers. * The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment. * Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients diagnosed with placenta praevia antenatally
- plan is elective caesarean section
- Gestational age >34 weeks
Key exclusion criteria (6 listed)
- Fetal distress
- medical disorders as hypertension or Diabetes Mellitus
- Coagulation defects.
- Emergency Cesarean section
- women with antepartum hemorrhage
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 |
|---|---|---|
| uterine artery ligationUterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged | Procedure or surgery | uterine artery ligation |
| Lower segment Cesarean sectionPfannenstiel incision of skin and opening of the anterior abdominal wall in layers. - The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment. Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta Delivery of the baby and placenta. * Closure of the uterine incision in 2 layers with N0. 1 vicryl suture. * Closure of the anterior abdominal wall in layers | Procedure or surgery | Traditional lower segment Cesarean section, uterine artery ligation |
Primary outcome
Decrease in Hemoglabin level
Time frame: 24 hours after Cesarean
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Individual participant dataSharing planned: Yes
Related trials for Placenta Previa
Not yet recruiting
ERAS Protocol for Cesarean Delivery in Women With Placenta Previa
Placenta Previa
Not yet recruitingObservational study
Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
Placenta Accreta Spectrum, Placenta Previa
RecruitingObservational study
AI Blind-Sweep Ultrasound for Antenatal Screening by Non-Specialist Health Workers in Rural DR Congo
Antenatal Care, Maternal Health
Recruiting
Effect of a Cervical Pessary on the Rate of Bleeding in Placenta Praevia
Placenta Previa
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.
Ahmed Maged, MD principal investigator
Kasr Alainy medical school
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uterine artery ligation and Lower segment Cesarean section in people with Placenta Previa, run by Cairo 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 6 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 31 Jan 2018. 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.
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 Ahmed Maged, MD (01005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Hemoglabin level (time frame: 24 hours after Cesarean). 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 31 Jan 2018.