Cesarean Section ComplicationsNCT03774524
Sublingual Misoprostol and Tranexamic Acid in Pregnant Women With Twin Pregnancy Undergoing Cesarean Section
A study testing Misoprostol and TA in people with Cesarean Section Complications, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
Purpose to evaluate the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Misoprostol and TA
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Mar 2021
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with a multiple term pregnancy undergoing elective cesarean section
Who cannot join
- single gestation
- placenta praevia and placental abruption
- undergoing cesarean section with general anesthesia
- women undergoing cesarean section at less than 37 weeks of gestation
- with a severe medical disorder
- allergy to tranexamic acid or misoprostol
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University
Aswān, 81528
hany f sallam, md, 01092440504 ext. 002, nahla.elsayed@aswu.ed.eg
Nahla w Shady, md, 1019240504 ext. 002, nahla.elsayed@aswu.edu.eg
About this study
Official title: Effects of Co-administered Sublingual Misoprostol and Intravenous Tranexamic Acid on Prevention of Postpartum Hemorrhage in Pregnant Women With Twin Pregnancy Undergoing Elective Cesarean Section: A Double-Blind Randomized Clinical Trial
Purpose to evaluate the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean section.
Read the detailed description
Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine contraction following delivery is an important issue. Risk factors of uterine atony include obesity, White or Hispanic race/ethnicity, polyhydramnios, preeclampsia, anemia, and chorioamnionitis as well as a twin pregnancy.
With the increasingly common use of ovulation induction and assisted reproduction techniques, the incidence of multiple gestation pregnancies has progressively increased. Suzuki et al reported that elective cesarean delivery of twin pregnancy at a gestational age of 37 weeks or greater may increase the risk of blood transfusion. Several uterotonic agents are used to prevent PPH because of uterine atony, including oxytocin, an ergot alkaloid, and prostaglandin. However, there are currently no data to evaluate the efficacy of co-administered Sublingual Misoprostol and Intravenous Tranexamic Acid on prevention of postpartum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean. therefore, this study was designed to evaluate and compare these two new therapeutic options in controlling PPH following CS for twin pregnancy
- Conditions
- Cesarean Section Complications
- Being tested
- Misoprostol, TA, placebo to misoprostol, placebo to TA
- Keywords
- cesarean section, tranexamic acid, postpartum hemorrhage, misoprostol
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Active Comparator
400 μg of sublingual misoprostol
TADrug
Also called Active Comparator
1 gm of tranexamic acid in 100 ml saline iv
placebo to misoprostolDrug
Also called Placebo comparator
placebo tablets to misoprostol subligual
placebo to TADrug
Also called placebo comparator
110 ml saline iv
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol with TA | Active comparator | 400 μg of sublingual misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout Receives: Drug: Misoprostol; Drug: TA |
| Misoprostol with placebo to TA | Active comparator | 400 μg of sublingual misoprostol (two tablets) plus 110 ml saline by iv rout Receives: Drug: Misoprostol; Drug: placebo to misoprostol |
| placebo to Misoprostol with placebo to TA | Placebo comparator | placebo to misoprostol plus placebo to tranexamic acid Receives: Drug: placebo to misoprostol; Drug: placebo to TA |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimation of intraoperative blood loss (ml)
measure Intraoperative blood loss in ml by gravimetric methods
Measured: during the operation
Secondary outcomes (2)
amount of postoperative blood loss
measure amount of blood loss post operative in ml by gravimetric methods
Measured: 6 hours post operative
number of patient with postpartum hemorrhage
calculation of the number of the patients with blood loss >1000 ml
Measured: 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start1 Jan 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies 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
- Model description
- A Double-Blind Randomized Clinical Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- hany f sallam, md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774524
- Sponsor's protocol ID
- aswu / 183/18
- Status last verified
- Feb 2019
- First submitted
- 12 Dec 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Co-administered Sublingual Misoprostol and Intravenous Tranexamic Acid on Prevention of Postpartum Hemorrhage in Pregnant Women With Twin Pregnancy Undergoing Elective Cesarean Section: A Double-Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03774524
- Acronym / sponsor ID
- aswu / 183/18
- Conditions
- Cesarean Section Complications
- Keywords
- cesarean section, tranexamic acid, postpartum hemorrhage, misoprostol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 13 Dec 2018 (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.
Purpose to evaluate the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean section.
Detailed description
Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine contraction following delivery is an important issue. Risk factors of uterine atony include obesity, White or Hispanic race/ethnicity, polyhydramnios, preeclampsia, anemia, and chorioamnionitis as well as a twin pregnancy.
With the increasingly common use of ovulation induction and assisted reproduction techniques, the incidence of multiple gestation pregnancies has progressively increased. Suzuki et al reported that elective cesarean delivery of twin pregnancy at a gestational age of 37 weeks or greater may increase the risk of blood transfusion. Several uterotonic agents are used to prevent PPH because of uterine atony, including oxytocin, an ergot alkaloid, and prostaglandin. However, there are currently no data to evaluate the efficacy of co-administered Sublingual Misoprostol and Intravenous Tranexamic Acid on prevention of postpartum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean. therefore, this study was designed to evaluate and compare these two new therapeutic options in controlling PPH following CS for twin pregnancy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A Double-Blind Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Misoprostol with TA | Active comparator | Drug: Misoprostol, Drug: TA400 μg of sublingual misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout |
| Misoprostol with placebo to TA | Active comparator | Drug: Misoprostol, Drug: placebo to misoprostol400 μg of sublingual misoprostol (two tablets) plus 110 ml saline by iv rout |
| placebo to Misoprostol with placebo to TA | Placebo comparator | Drug: placebo to misoprostol, Drug: placebo to TAplacebo to misoprostol plus placebo to tranexamic acid |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with a multiple term pregnancy undergoing elective cesarean section
Key exclusion criteria (6 listed)
- single gestation
- placenta praevia and placental abruption
- undergoing cesarean section with general anesthesia
- women undergoing cesarean section at less than 37 weeks of gestation
- with a severe medical disorder
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: Active Comparator400 μg of sublingual misoprostol | Drug | Misoprostol with TA, Misoprostol with placebo to TA |
| TAAlso: Active Comparator1 gm of tranexamic acid in 100 ml saline iv | Drug | Misoprostol with TA |
| placebo to misoprostolAlso: Placebo comparatorplacebo tablets to misoprostol subligual | Drug | Misoprostol with placebo to TA, placebo to Misoprostol with placebo to TA |
| placebo to TAAlso: placebo comparator110 ml saline iv | Drug | placebo to Misoprostol with placebo to TA |
Primary outcome
estimation of intraoperative blood loss (ml)
Time frame: during the operation
measure Intraoperative blood loss in ml by gravimetric methods
2 secondary outcomes
amount of postoperative blood loss
Time frame: 6 hours post operative
number of patient with postpartum hemorrhage
Time frame: 24 hours post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
hany f sallam, md principal investigator
Aswan 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 Misoprostol and TA in people with Cesarean Section Complications, run by Aswan 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 1 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 15 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hany f sallam, md (01022336052 ext. 002, hany.farouk@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
estimation of intraoperative blood loss (ml) (time frame: during the operation). 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 15 Feb 2019.