Placenta Previa Without HemorrhageNCT02002026
Uterine Artery Ligation to Decrease Blood Loss With Central Placenta Previa
A study testing Uterine artery ligation in people with Placenta Previa Without Hemorrhage, run by Minia Maternity University Hospital at 1 site in Egypt.
Trial summary
This trial will address the effect of uterine artery ligation during Cesarean section in cases with placenta previa to decrease blood loss. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Previa Without Hemorrhage
- What is being tested?
- Uterine artery ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2013to Nov 2014
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Placenta previa is diagnosed when the lowest placental edge is located within 5 cm of the internal os at ultrasound
- Symptomatic Placenta previa with at least one episode of bleeding
- Estimated gestational age within 28 to 40 weeks
- Maternal age > 18 years
- Informed consent
- Social affiliation
Who cannot join
- Premature rupture of membranes
- Severe bleeding.
- Abnormal fetal heart rates.
- Pre-eclampsia, chorioamnionitis, severe chronic renal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uterine Artery Ligation to Minimize Blood Loss in Patients With Central Placenta Previa
This trial will address the effect of uterine artery ligation during Cesarean section in cases with placenta previa to decrease blood loss.
Read the detailed description
This Study will address the effect of uterine artery ligation prior to fetal delivery during Cesarean section in cases with central placenta previa to guard against postpartum hemorrhage and to minimize blood loss.
- Conditions
- Placenta Previa Without Hemorrhage
- Being tested
- Uterine artery ligation
- Keywords
- placenta previa, uterine artery ligation
- 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 during cesarean section before delivery of the baby
| Study group | Role | What they receive |
|---|---|---|
| Ligation group | Active comparator | Uterine artery ligation will be done for patients in this group Receives: Procedure: Uterine artery ligation |
| Control group | Placebo comparator | Conventional CS Receives: Procedure: Uterine artery ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hemoglobin level
Changes in hemoglobin level before and after CS will reflect the amount of blood loss during operation
Measured: hemoglobin level will be done baseline and will be repeated 24 hours after delivery
Secondary outcomes (1)
Degree of uterine contractility.
Measured: During CS and within 3 hours after CS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Placenta Previa Without HemorrhageStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia Maternity University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Sameer Sanad, Minia Maternity University Hospital
- Investigators
- Ahmad S Sameer, MD, Principal investigator, Minia Maternity University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002026
- Sponsor's protocol ID
- U1111-1150-4666
- Status last verified
- Mar 2016
- First submitted
- 18 Nov 2013
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sanad AS, Mahran AE, Aboulfotouh ME, Kamel HH, Mohammed HF, Bahaa HA, Elkateeb RR, Abdelazim AG, El-Din MAZ, Shawki HE. The effect of uterine artery ligation in patients with central placenta pevia: a randomized controlled trial. BMC Pregnancy Childbirth. 2018 Aug 29;18(1):351. doi: 10.1186/s12884-018-1989-5.
PubMed 30157787
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Artery Ligation to Minimize Blood Loss in Patients With Central Placenta Previa
- ClinicalTrials.gov ID
- NCT02002026
- Acronym / sponsor ID
- U1111-1150-4666
- Conditions
- Placenta Previa Without Hemorrhage
- Keywords
- placenta previa, uterine artery ligation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Minia Maternity University HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 5 Dec 2013 (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.
This trial will address the effect of uterine artery ligation during Cesarean section in cases with placenta previa to decrease blood loss.
Detailed description
This Study will address the effect of uterine artery ligation prior to fetal delivery during Cesarean section in cases with central placenta previa to guard against postpartum hemorrhage and to minimize blood loss.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ligation group | Active comparator | Procedure: Uterine artery ligationUterine artery ligation will be done for patients in this group |
| Control group | Placebo comparator | Procedure: Uterine artery ligationConventional CS |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Placenta previa is diagnosed when the lowest placental edge is located within 5 cm of the internal os at ultrasound
- Symptomatic Placenta previa with at least one episode of bleeding
- Estimated gestational age within 28 to 40 weeks
- Maternal age > 18 years
- Informed consent
Key exclusion criteria (4 listed)
- Premature rupture of membranes
- Severe bleeding.
- Abnormal fetal heart rates.
- Pre-eclampsia, chorioamnionitis, severe chronic renal disease.
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 during cesarean section before delivery of the baby | Procedure or surgery | Control group, Ligation group |
Primary outcome
Changes in hemoglobin level
Time frame: hemoglobin level will be done baseline and will be repeated 24 hours after delivery
Changes in hemoglobin level before and after CS will reflect the amount of blood loss during operation
1 secondary outcome
Degree of uterine contractility.
Time frame: During CS and within 3 hours after CS
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 16 Mar 2016.
- Derived from this study: PubMed 30157787Sanad AS, Mahran AE, Aboulfotouh ME, Kamel HH, Mohammed HF, Bahaa HA, Elkateeb RR, Abdelazim AG, El-Din MAZ, Shawki HE. The effect of uterine artery ligation in patients with central placenta pevia: a randomized controlled trial. BMC Pregnancy Childbirth. 2018 Aug 29;18(1):351. doi: 10.1186/s12884-018-1989-5.
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.
Ahmad S Sameer, MD principal investigator
Minia Maternity University Hospital
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 in people with Placenta Previa Without Hemorrhage, run by Minia Maternity University Hospital 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 6 inclusion and 4 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 16 Mar 2016. 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. Some participants in this study may receive a placebo. 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?
Changes in hemoglobin level (time frame: hemoglobin level will be done baseline and will be repeated 24 hours after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02002026, which also lists 1 linked publication.
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 16 Mar 2016.