Postpartum HemorrhageNCT05670886
Routine Bilateral Uterine Artery Ligation During the Cesarean Delivery of Multiple Gestation
A study testing uterine artery ligation in people with Postpartum Hemorrhage, run by Cairo University at 1 site in Egypt.
Trial summary
Multiple pregnancy is well defined to be associated with a greater risk of postpartum blood loss . Interventions to control PPH generally stepped from less to more invasive and including compression maneuvers , drugs , and further radical surgeries. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- uterine artery ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 30 Jan 2023
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women undergoing cesarean section
- multiple pregnancy
Who cannot join
- Placenta previa.
- Ante-partum hemorrhage.
- patient refuse to participate
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy outpatient infertility clinic
Cairo
bassiony dabian, MD, 1095195513, bassiony.dabian@gmail.com
About this study
Multiple pregnancy is well defined to be associated with a greater risk of postpartum blood loss . Interventions to control PPH generally stepped from less to more invasive and including compression maneuvers , drugs , and further radical surgeries. Conservative management plans such as medications which cause the uterus to contract, external massage to the uterine body , and bimanual compression are overall used as 1st line interventions.
PPH was defined as a cumulative blood loss of 1,000 mL or more, or blood loss that occurred within 24 hours of childbirth and was accompanied by indications or symptoms of hypervolemia. The most frequent cause of PPH, which accounted for roughly 80% of cases, is uterine atony (3).
Read more
PPH is brought on by hyperexpansion, which impaired uterine myometrial contractility and caused uterine contraction fatigue , PPH were twice as high when pregnant with twins (4).The only effective surgical treatment for blood loss is a hysterectomy, but this is a risky procedure, especially for young women.(5)
Due to this, a number of fertility-preserving surgical procedures have been developed, including the B-Lynch technique, internal iliac artery ligation, and uterine artery ligation (UAL) One of the most widely used surgical methods for preserving fertility is UAL. It is simple to carry out and works well to control PPH. Additionally, it permits patients to have more children in the future and is generally safe. Additionally, it has a success rate of above 90%.
Concerns have been raised about its effect on women who want to become pregnant in the future regarding their ovarian reserve. The accepted practice of medicine worldwide is the prophylactic use of uterotonics. A synthetic oxytocin analogue with a lengthy half-life, carbetocin also stimulates uterine contractions .
One benefit of carbetocin over oxytocin is that it is more heat-stable, which is of greater importance to low resource settings . Studies compare the effectiveness of carbetocin and oxytocin in preventing PPH and find that carbetocin is equally effective or even more effective.
Read the detailed description
This study is a randomized controlled study including a total number of 110 patients presenting to Kasr Al-ainy obstetrics and gynecology hospital for CS delivery. Ethical committee approved this study.
Patients are equally \& randomly divided into two equal groups . Group (A) , study group (N=55) : patients with multiple pregnancy undergoing cesarean section undergoing bilateral uterine artery ligation and received carbetocin.
Group (B ) , control group (N=55) : patients with twin pregnancy undergoing cesarean section received carbetocin only.
Pregnant patients aging between 18 to 42 undergoing cesarean section for multiple pregnancy are included in this study , while Patients with Placenta previa or accrete , Ante-partum hemorrhage , patient refusing to participate , patients with medical disorders and patients with pre-operative HB less than 9 gm/dl were excluded from the study.
Informed consent was taken from involved patients after explanation of the procedures and their complications , and allocated patients were subjected to : (1) History taking regarding age , parity , previous CS , previous PPH , menstrual , medical and surgical history . (2) Examination : including general exam.(BMI , Blood Pressure ) , Abdominal examination ( Leopold's maneuvers , CS scars , fetal heart sounds , fundal level ) \& local vaginal examination .
(3)Ultrasound was done to detect number of fetuses , gestational age , presentations , placental sites , amount of liquor \& fetal weight. Patients were prepared for CS delivery after requesting pre-operative labs.
Anesthesia: spinal is mainly used except in cases were general anesthesia is indicated as fetal distress. Urinary catheterization and skin preparation was done. Skin incision using Pfannenstiel incision , opening abdomen in layers . The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally Lower uterine incision was done followed by fetal extraction and placental delivery . Group (A): a single dose of 100 microgram carbetocin (Pabal® , ferring ) IV injection \& bilateral uterine artery ligation were done 2cm below the uterine incision. Group (B): only a single dose of 100 microgram carbetocin (Pabal® , ferring ) IV injection administered after the delivery of the infant .
Closure of uterine incision \& proper hemostasis were done . The abdomen was closed in layers . Patients were observed postpartum for vaginal bleeding , vitals , uterine tone , urine output \& postoperative hemoglobin.
Operative time was calculated from the time of skin incision to tome of skin closure. Blood loss was calculated by Visual estimation by different operating room staff: the anesthetist, the obstetrician as well as the scrub nurse ( estimate the loss by careful observation of the operative field during surgery and report it at the end.) \& by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set. PPH was defined as blood loss of ≥1,000 ml following delivery (11).
Statistical Analyses were done using the Statistical Package for the Social Sciences (SPSS) , version 23. Quantitative Data were reported as mean± SD, while qualitative data were reported as number and percentage. The chi square test was used to compare categorical variables; P value <0.05 was considered significant.
- Conditions
- Postpartum Hemorrhage
- Being tested
- uterine artery ligation
- Keywords
- PPH - uterine artery ligation - carbetocin - multiple gesation
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterine artery ligationProcedure or surgery
Also called carbetocin
The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally Lower uterine incision was done followed by fetal extraction and placental delivery . bilateral uterine artery ligation were done 2cm below the uterine incision.
| Study group | Role | What they receive |
|---|---|---|
| uterine artery ligation + carbetocin | Experimental | Group (A) , study group (N=55) : patients with multiple pregnancy undergoing cesarean section underwent bilateral uterine artery ligation and received carbetocin. Receives: Procedure: uterine artery ligation |
| carbetocin only | Active comparator | Group (B ) , control group (N=55) : patients with twin pregnancy undergoing cesarean section received carbetocin only. Receives: Procedure: uterine artery ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean Blood loss after placental separation
by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set
Measured: 30 minutes
Secondary outcomes (2)
Number of Participants with postpartum hemorrhage
number pf participants with blood loss > 1000ml
Measured: 12 hours
The number of participant needed for blood transfusion
Calculation of the number of participant needed for blood transfusion
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Jun 2022
- Primary completion5 Jan 2023 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassiony Dabian, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670886
- Sponsor's protocol ID
- 23BM73
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.
PubMed 28937571Santana DS, Cecatti JG, Surita FG, Silveira C, Costa ML, Souza JP, Mazhar SB, Jayaratne K, Qureshi Z, Sousa MH, Vogel JP; WHO Multicountry Survey on Maternal and Newborn Health Research Network. Twin Pregnancy and Severe Maternal Outcomes: The World Health Organization Multicountry Survey on Maternal and Newborn Health. Obstet Gynecol. 2016 Apr;127(4):631-641. doi: 10.1097/AOG.0000000000001338.
PubMed 26959199Gallos ID, Williams HM, Price MJ, Merriel A, Gee H, Lissauer D, Moorthy V, Tobias A, Deeks JJ, Widmer M, Tuncalp O, Gulmezoglu AM, Hofmeyr GJ, Coomarasamy A. Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2018 Apr 25;4(4):CD011689. doi: 10.1002/14651858.CD011689.pub2.
PubMed 29693726Tulandi T, Sammour A, Valenti D, Child TJ, Seti L, Tan SL. Ovarian reserve after uterine artery embolization for leiomyomata. Fertil Steril. 2002 Jul;78(1):197-8. doi: 10.1016/s0015-0282(02)03164-3. No abstract available.
PubMed 12095516
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Bilateral Uterine Artery Ligation During the Cesarean Delivery of Multiple Gestation
- ClinicalTrials.gov ID
- NCT05670886
- Acronym / sponsor ID
- 23BM73
- Conditions
- Postpartum Hemorrhage
- Keywords
- PPH - uterine artery ligation - carbetocin - multiple gesation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 5 Jan 2023 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 4 Jan 2023 (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.
Multiple pregnancy is well defined to be associated with a greater risk of postpartum blood loss . Interventions to control PPH generally stepped from less to more invasive and including compression maneuvers , drugs , and further radical surgeries. Conservative management plans such as medications which cause the uterus to contract, external massage to the uterine body , and bimanual compression are overall used as 1st line interventions.
PPH was defined as a cumulative blood loss of 1,000 mL or more, or blood loss that occurred within 24 hours of childbirth and was accompanied by indications or symptoms of hypervolemia. The most frequent cause of PPH, which accounted for roughly 80% of cases, is uterine atony (3).
PPH is brought on by hyperexpansion, which impaired uterine myometrial contractility and caused uterine contraction fatigue , PPH were twice as high when pregnant with twins (4).The only effective surgical treatment for blood loss is a hysterectomy, but this is a risky procedure, especially for young women.(5)
Due to this, a number of fertility-preserving surgical procedures have been developed, including the B-Lynch technique, internal iliac artery ligation, and uterine artery ligation (UAL) One of the most widely used surgical methods for preserving fertility is UAL. It is simple to carry out and works well to control PPH. Additionally, it permits patients to have more children in the future and is generally safe. Additionally, it has a success rate of above 90%.
Concerns have been raised about its effect on women who want to become pregnant in the future regarding their ovarian reserve. The accepted practice of medicine worldwide is the prophylactic use of uterotonics. A synthetic oxytocin analogue with a lengthy half-life, carbetocin also stimulates uterine contractions .
One benefit of carbetocin over oxytocin is that it is more heat-stable, which is of greater importance to low resource settings . Studies compare the effectiveness of carbetocin and oxytocin in preventing PPH and find that carbetocin is equally effective or even more effective.
Detailed description
This study is a randomized controlled study including a total number of 110 patients presenting to Kasr Al-ainy obstetrics and gynecology hospital for CS delivery. Ethical committee approved this study.
Patients are equally \& randomly divided into two equal groups . Group (A) , study group (N=55) : patients with multiple pregnancy undergoing cesarean section undergoing bilateral uterine artery ligation and received carbetocin.
Group (B ) , control group (N=55) : patients with twin pregnancy undergoing cesarean section received carbetocin only.
Pregnant patients aging between 18 to 42 undergoing cesarean section for multiple pregnancy are included in this study , while Patients with Placenta previa or accrete , Ante-partum hemorrhage , patient refusing to participate , patients with medical disorders and patients with pre-operative HB less than 9 gm/dl were excluded from the study.
Informed consent was taken from involved patients after explanation of the procedures and their complications , and allocated patients were subjected to : (1) History taking regarding age , parity , previous CS , previous PPH , menstrual , medical and surgical history . (2) Examination : including general exam.(BMI , Blood Pressure ) , Abdominal examination ( Leopold's maneuvers , CS scars , fetal heart sounds , fundal level ) \& local vaginal examination .
(3)Ultrasound was done to detect number of fetuses , gestational age , presentations , placental sites , amount of liquor \& fetal weight. Patients were prepared for CS delivery after requesting pre-operative labs.
Anesthesia: spinal is mainly used except in cases were general anesthesia is indicated as fetal distress. Urinary catheterization and skin preparation was done. Skin incision using Pfannenstiel incision , opening abdomen in layers . The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally Lower uterine incision was done followed by fetal extraction and placental delivery . Group (A): a single dose of 100 microgram carbetocin (Pabal® , ferring ) IV injection \& bilateral uterine artery ligation were done 2cm below the uterine incision. Group (B): only a single dose of 100 microgram carbetocin (Pabal® , ferring ) IV injection administered after the delivery of the infant .
Closure of uterine incision \& proper hemostasis were done . The abdomen was closed in layers . Patients were observed postpartum for vaginal bleeding , vitals , uterine tone , urine output \& postoperative hemoglobin.
Operative time was calculated from the time of skin incision to tome of skin closure. Blood loss was calculated by Visual estimation by different operating room staff: the anesthetist, the obstetrician as well as the scrub nurse ( estimate the loss by careful observation of the operative field during surgery and report it at the end.) \& by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set. PPH was defined as blood loss of ≥1,000 ml following delivery (11).
Statistical Analyses were done using the Statistical Package for the Social Sciences (SPSS) , version 23. Quantitative Data were reported as mean± SD, while qualitative data were reported as number and percentage. The chi square test was used to compare categorical variables; P value <0.05 was considered significant.
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 + carbetocin | Experimental | Procedure: uterine artery ligationGroup (A) , study group (N=55) : patients with multiple pregnancy undergoing cesarean section underwent bilateral uterine artery ligation and received carbetocin. |
| carbetocin only | Active comparator | Procedure: uterine artery ligationGroup (B ) , control group (N=55) : patients with twin pregnancy undergoing cesarean section received carbetocin only. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women undergoing cesarean section
- multiple pregnancy
Key exclusion criteria (3 listed)
- Placenta previa.
- Ante-partum hemorrhage.
- patient refuse to participate
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 ligationAlso: carbetocinThe peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally Lower uterine incision was done followed by fetal extraction and placental delivery . bilateral uterine artery ligation were done 2cm below the uterine incision. | Procedure or surgery | carbetocin only, uterine artery ligation + carbetocin |
Primary outcome
mean Blood loss after placental separation
Time frame: 30 minutes
by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set
2 secondary outcomes
Number of Participants with postpartum hemorrhage
Time frame: 12 hours
The number of participant needed for blood transfusion
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Background: PubMed 28937571Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.
- Background: PubMed 26959199Santana DS, Cecatti JG, Surita FG, Silveira C, Costa ML, Souza JP, Mazhar SB, Jayaratne K, Qureshi Z, Sousa MH, Vogel JP; WHO Multicountry Survey on Maternal and Newborn Health Research Network. Twin Pregnancy and Severe Maternal Outcomes: The World Health Organization Multicountry Survey on Maternal and Newborn Health. Obstet Gynecol. 2016 Apr;127(4):631-641. doi: 10.1097/AOG.0000000000001338.
- Background: PubMed 29693726Gallos ID, Williams HM, Price MJ, Merriel A, Gee H, Lissauer D, Moorthy V, Tobias A, Deeks JJ, Widmer M, Tuncalp O, Gulmezoglu AM, Hofmeyr GJ, Coomarasamy A. Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2018 Apr 25;4(4):CD011689. doi: 10.1002/14651858.CD011689.pub2.
- Background: PubMed 12095516Tulandi T, Sammour A, Valenti D, Child TJ, Seti L, Tan SL. Ovarian reserve after uterine artery embolization for leiomyomata. Fertil Steril. 2002 Jul;78(1):197-8. doi: 10.1016/s0015-0282(02)03164-3. No abstract available.
- Individual participant dataSharing planned: Yes
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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.
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 Postpartum Hemorrhage, 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 2 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 4 Jan 2023. 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 bassiony dabian, MD (1095195513, bassiony.dabian@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean Blood loss after placental separation (time frame: 30 minutes). 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 NCT05670886, which also lists 4 linked publications.
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 4 Jan 2023.