Blood Loss, SurgicalNCT06049160
Comparative Study Between Preoperative and Postoperative Rectal Misoprostol
A study testing Misoprostol in people with Blood Loss, Surgical and Blood Loss, Postoperative, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Cesarean delivery (CD) is the most common major surgical procedure undergone by women around the world. Over the past two decades, there has been a witnessed increase in rates of caesarean deliveries, which continues to rise, achieving 30% in resource-rich countries and exceeding 60% in resource-limited countries. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Blood Loss, Surgical, Blood Loss, Postoperative
- What is being tested?
- Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Aug 2023to 30 Nov 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age ( 37 to 41 weeks).
- Singleton healthy fetus.
- Scheduled for elective lower segment caesarean delivery under spinal anaesthesia.
- Body mass index of (25-30 Kg/m2).
- Normal coagulation profile.
- Normal amniotic fluid volume assessed by amniotic fluid index.
Who cannot join
- Maternal comorbidity: Hypertension; diabetes; heart, kidney, or liver disorders.
- Contraindication to use of misoprostol like known allergy to misoprostol or asthmatic patients.
- Women who had undergone any previous uterine surgery such as myomectomy because it is considered upper uterine segment operation with more destruction in myometrium but caesarean section is a lower segment uterine operation with minimal destruction in myometrium.
- Women at higher risk of intraoperative blood loss or PPH, such as those with hemoglobin levels less than 9 g/dl, history of PPH, or uterine fibroids.
- Antepartum hemorrhage ( placenta previa and placental abruption).
- Women who will undergo caesarean section because of failure of induction of labor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Preoperative and Postoperative Rectal Misoprostol in the Reduction of Blood Loss During and After Elective Cesarean Section : A Double Blinded Randomized Controlled Trial
Cesarean delivery (CD) is the most common major surgical procedure undergone by women around the world. Over the past two decades, there has been a witnessed increase in rates of caesarean deliveries, which continues to rise, achieving 30% in resource-rich countries and exceeding 60% in resource-limited countries. According to a Lancet report 2014, Egypt is one of the countries with the highest rates of caesarean delivery, in which the rate had reached 55.5%. The rate is almost double to three times the ideal rate of 10%-15%
Read the detailed description
In resource-limited countries, postpartum hemorrhage (PPH) remains the leading cause of maternal mortality. The increased rates of caesarean delivery have been incriminated as the primary cause behind the rise in PPH. PPH after a caesarean delivery has been defined as blood loss over 1000 ml. The estimated prevalence rate of PPH is in the range of 0.6%-6.4%.
Increased blood loss after CD reflects several factors, including surgical incisions, lack of background uterine contraction, and manual removal of placenta rather than waiting for its spontaneous separation after placental bed retraction. Minimizing blood loss during delivery is an important preventive health objective aimed at reducing postpartum anemia and related morbidity .
It has been reported that the prevalence of postpartum anemia in low-income countries is approximately 50%-80%. The major cause of postpartum anemia is blood loss at delivery, especially in presence of prepartum anemia. Postpartum anemia constitutes an appreciable health problem among women of reproductive age and is associated with reduced quality of life, impaired cognition, emotional instability, and depression.
Oxytocin is routinely used by obstetricians to prevent excessive blood loss during CD. Oxytocin is the uterotonic of choice in obstetric medicine. Both the Royal College of Obstetricians and Gynecologists and the American College of Obstetricians and Gynecologists currently recommend the routine use of oxytocin (5 IU bolus dose or infusion, respectively) after the delivery of the infant as a prophylactic measure against PPH. However, oxytociin is a dangerous drug with serious adverse effects such as hypotension, tachyc ardiaand myocardial ischemia .
Misoprostol is a prostaglandin E1 analogue that effectively prevents and treats PPH owin g to its uterotonic properties. It can be used through different routes: oral; sublingual; bucc al; rectal; and intrauterine with similar efficacy to oxytocin in reducing blood loss. The benefits of misoprostol (cervical dilation and uterine contractions) and its adverse effects (nausea, vomiting, diarrhea, fever, and chills) are dose dependent .
Misoprostol is affordable and widely available, easily administered via multiple routes ( vaginal, rectal, sublingual, and oral), and has a good safety profile if properly administered and monitored, all of which make it the standard treatment option for PPH in low-resource settings.
Misoprostol administered vaginally is affected by vaginal acidity and the bacterial micro-environment. Sublingual route has the highest peak concentration; however, it is also associated with the highest incidence of adverse effects due to high peak concentrati on. Rectally administered misoprostol is associated with slower absorption, lower peak c oncentration levels, and reduced adverse effects compared with the oral and sublingua l routes.
- Conditions
- Blood Loss, Surgical, Blood Loss, Postoperative
- Being tested
- Misoprostol
- Keywords
- blood loss, Cesarean Section, Oxytocin, Rectal Misoprostol
- Medical subject headings
- Blood Loss, Surgical, Postoperative Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Syntocinon
All participants will be assigned for giving misoprostol rectally either preoperative or postoperative
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative and post-operative rectal misoprostol | Active comparator | 64 participants who will receive combined pre-operative and post-operative rectal misoprostol (400μg rectal misoprostol during urinary catheter insertion just after spinal anesthesia plus 200μg after abdominal closure). Receives: Drug: Misoprostol |
| Post-operative rectal misoprostol | Active comparator | 64 participants who will receive rectal misoprostol post-operative only (600μg of rectal misoprostol after closure of the Cesarean Wound)). Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss (defined as blood loss ≥500 cc)
Outcome of the study will be measured in terms of assessment of Hemoglobin level
Measured: First 2 hours from the starting of the operation
Intraoperative blood loss (defined as blood loss ≥500 cc)
Outcome of the study will be measured in terms of assessment of Hematocrit level
Measured: First 2 hours from the starting of the operation
Secondary outcomes (2)
Occurrence of primary postpartum hemorrhage ( defined as excessive blood loss as 1000cc during first 24 hours)
Outcome of the study will be measured in terms of assessment of Hemoglobin level post operatively.
Measured: first 24 hours after C-Section]
Occurrence of primary postpartum hemorrhage ( defined as excessive blood loss as 1000cc during first 24 hours)
Outcome of the study will be measured in terms of assessment of Hematocrit level post operatively.
Measured: first 24 hours after C-Section]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start31 Aug 2023
- Primary completion20 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Waleed El-Khayat, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049160
- Sponsor's protocol ID
- Martina Asaad
- Status last verified
- Oct 2023
- First submitted
- 15 Sep 2023
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Preoperative and Postoperative Rectal Misoprostol in the Reduction of Blood Loss During and After Elective Cesarean Section : A Double Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06049160
- Acronym / sponsor ID
- Martina Asaad
- Conditions
- Blood Loss, Surgical, Blood Loss, Postoperative
- Keywords
- blood loss, Cesarean Section, Oxytocin, Rectal Misoprostol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 21 Sep 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.
Cesarean delivery (CD) is the most common major surgical procedure undergone by women around the world. Over the past two decades, there has been a witnessed increase in rates of caesarean deliveries, which continues to rise, achieving 30% in resource-rich countries and exceeding 60% in resource-limited countries. According to a Lancet report 2014, Egypt is one of the countries with the highest rates of caesarean delivery, in which the rate had reached 55.5%. The rate is almost double to three times the ideal rate of 10%-15%
Detailed description
In resource-limited countries, postpartum hemorrhage (PPH) remains the leading cause of maternal mortality. The increased rates of caesarean delivery have been incriminated as the primary cause behind the rise in PPH. PPH after a caesarean delivery has been defined as blood loss over 1000 ml. The estimated prevalence rate of PPH is in the range of 0.6%-6.4%.
Increased blood loss after CD reflects several factors, including surgical incisions, lack of background uterine contraction, and manual removal of placenta rather than waiting for its spontaneous separation after placental bed retraction. Minimizing blood loss during delivery is an important preventive health objective aimed at reducing postpartum anemia and related morbidity .
It has been reported that the prevalence of postpartum anemia in low-income countries is approximately 50%-80%. The major cause of postpartum anemia is blood loss at delivery, especially in presence of prepartum anemia. Postpartum anemia constitutes an appreciable health problem among women of reproductive age and is associated with reduced quality of life, impaired cognition, emotional instability, and depression.
Oxytocin is routinely used by obstetricians to prevent excessive blood loss during CD. Oxytocin is the uterotonic of choice in obstetric medicine. Both the Royal College of Obstetricians and Gynecologists and the American College of Obstetricians and Gynecologists currently recommend the routine use of oxytocin (5 IU bolus dose or infusion, respectively) after the delivery of the infant as a prophylactic measure against PPH. However, oxytociin is a dangerous drug with serious adverse effects such as hypotension, tachyc ardiaand myocardial ischemia .
Misoprostol is a prostaglandin E1 analogue that effectively prevents and treats PPH owin g to its uterotonic properties. It can be used through different routes: oral; sublingual; bucc al; rectal; and intrauterine with similar efficacy to oxytocin in reducing blood loss. The benefits of misoprostol (cervical dilation and uterine contractions) and its adverse effects (nausea, vomiting, diarrhea, fever, and chills) are dose dependent .
Misoprostol is affordable and widely available, easily administered via multiple routes ( vaginal, rectal, sublingual, and oral), and has a good safety profile if properly administered and monitored, all of which make it the standard treatment option for PPH in low-resource settings.
Misoprostol administered vaginally is affected by vaginal acidity and the bacterial micro-environment. Sublingual route has the highest peak concentration; however, it is also associated with the highest incidence of adverse effects due to high peak concentrati on. Rectally administered misoprostol is associated with slower absorption, lower peak c oncentration levels, and reduced adverse effects compared with the oral and sublingua l routes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-operative and post-operative rectal misoprostol | Active comparator | Drug: Misoprostol64 participants who will receive combined pre-operative and post-operative rectal misoprostol (400μg rectal misoprostol during urinary catheter insertion just after spinal anesthesia plus 200μg after abdominal closure). |
| Post-operative rectal misoprostol | Active comparator | Drug: Misoprostol64 participants who will receive rectal misoprostol post-operative only (600μg of rectal misoprostol after closure of the Cesarean Wound)). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Gestational age ( 37 to 41 weeks).
- Singleton healthy fetus.
- Scheduled for elective lower segment caesarean delivery under spinal anaesthesia.
- Body mass index of (25-30 Kg/m2).
- Normal coagulation profile.
Key exclusion criteria (6 listed)
- Maternal comorbidity: Hypertension; diabetes; heart, kidney, or liver disorders.
- Contraindication to use of misoprostol like known allergy to misoprostol or asthmatic patients.
- Women who had undergone any previous uterine surgery such as myomectomy because it is considered upper uterine segment operation with more destruction in myometrium but caesarean section is a lower segment uterine operation with minimal destruction in myometrium.
- Women at higher risk of intraoperative blood loss or PPH, such as those with hemoglobin levels less than 9 g/dl, history of PPH, or uterine fibroids.
- Antepartum hemorrhage ( placenta previa and placental abruption).
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 |
|---|---|---|
| MisoprostolAlso: SyntocinonAll participants will be assigned for giving misoprostol rectally either preoperative or postoperative | Drug | Post-operative rectal misoprostol, Pre-operative and post-operative rectal misoprostol |
Primary outcome
Intraoperative blood loss (defined as blood loss ≥500 cc)
Time frame: First 2 hours from the starting of the operation
Outcome of the study will be measured in terms of assessment of Hemoglobin level
Intraoperative blood loss (defined as blood loss ≥500 cc)
Time frame: First 2 hours from the starting of the operation
Outcome of the study will be measured in terms of assessment of Hematocrit level
2 secondary outcomes
Occurrence of primary postpartum hemorrhage ( defined as excessive blood loss as 1000cc during first 24 hours)
Time frame: first 24 hours after C-Section]
Occurrence of primary postpartum hemorrhage ( defined as excessive blood loss as 1000cc during first 24 hours)
Time frame: first 24 hours after C-Section]
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 20 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Waleed El-Khayat, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol in people with Blood Loss, Surgical and Blood Loss, Postoperative, run by Egymedicalpedia 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 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: finished, as of the sponsor's last update on 20 Aug 2024. 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?
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?
Intraoperative blood loss (defined as blood loss ≥500 cc) (time frame: First 2 hours from the starting of the operation). The study lists 2 primary outcomes in all. 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 20 Aug 2024.