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Postpartum HemorrhageNCT06060327

Comparing Tranexamic Acid Versus Ecbolics in Preventing Hemorrhage During and After Cesarean Section

A study testing Tranexamic acid in people with Postpartum Hemorrhage and Blood Loss, Postoperative, run by Cairo University at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will include 444 pregnant patients undergoing cesarean section in Kasr Al Aini. Following a proper medical history taking, examination will be done, investigations including laboratory tests and obstetric ultrasound will be done. Read more about this study

Who is it for?
Ages 20 to 40 years, women onlyHealthy volunteers can take part
What is being tested?
Tranexamic acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
2 sitesEgypt
Study dates
15 Oct 2023to 15 Jun 2024
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 20 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 2. Pregnant women candidate for LSCS. 3. Age: 20-40 years old. 4. Full term pregnancies (> 37 weeks confirmed by the 1st day of the LMP or 1st trimesteric ultrasound scan).
  • 5. Singleton pregnancies. 6. One or more of the following criteria to be considered as high-risk case for PPH (RCOG, 2016):
  • Maternal Anemia (hemoglobin < 10 g%).
  • Known placenta previa.
  • Proven or suspected case of placental abruption.
  • Preeclampsia or gestational hypertension.
Show all 11Show fewer
  • Polyhydramnios (DVP > 8cm).
  • Macrosomia (> 4 Kg)
  • Previous history of uterine atony or postpartum hemorrhage).
  • Prolonged labour (>12 hours).
  • 7. CS under spinal anesthesia.

Who cannot join

  • 1. Fetal death (IUFD). 2. Fetal anomalies. 3. IUGR (Estimated fetal weight below the 5th centile) 4. Women presenting with an obstetric emergency necessitating immediate surgery (Cord prolapse, severe antepartum hemorrhage, severe fetal distress etc.) 5. More than 2 previous CS procedures. 6. Prolonged procedure (more than 2 hours from skin incision to skin closure). 7. History of prostaglandin, Tranexamic acid or carbetocin allergy. 8. Multifetal pregnancies. 9. Abnormally invasive placenta. 10. Known deep venous thrombosis

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites
  • kasr elainy hospital (Faculty of Medicine - Cairo University)

    Cairo, 115431

  • Faculty of medicine - Cairo university

    Cairo

Other trials in Egypt

About this study

Official title: The Efficacy and Safety of Tranexamic Acid Versus Uterotonic Agents in Reducing Blood Loss During and After Cesarean Section Among High-risk Patients: a Comparative Study

The study will include 444 pregnant patients undergoing cesarean section in Kasr Al Aini.

Following a proper medical history taking, examination will be done, investigations including laboratory tests and obstetric ultrasound will be done.

Then, the patients will be divided into 4 groups, receiving Oxytocin only (Group 1), Oxytocin + Tranexamic acid (Group 2), Oxytocin and Misoprostol (Group 3) or Oxytocin and Carbetocin (Group 4) followed by collection of necessary data.

Read the detailed description

The study will include (444) pregnant women attending for cesarean delivery in Kasr El Aini hospital (faculty of medicine - Cairo university).

The following will be done to all participants:

  • Informed written consent: after discussing the nature of the study as well as the expected value, outcome, and possible adverse effects.
  • Full medical history: including full obstetric history and current pregnancy history (entailing the 1st day of LMP).
  • Thorough Clinical Examination: general (maternal body weight and vital signs) and full obstetric examination.
  • Obstetric ultrasonography: to confirm singleton pregnancy, gestational age and the eligibility of the current pregnancy to participate in the study.
  • Preoperative laboratory tests: including prothrombin time, prothrombin concentration, complete blood count, and liver and kidney function tests.
  • Group allocation: Before surgery, participants will be randomly and equally assigned into four groups; Tranexamic Acid group, Misoprostol group, Carbetocin group and Oxytocin group. Randomization will be performed using computer-generated random numbers.
  • In Oxytocin group (n=111), patients will receive 10 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) given as infusion in 500 ml lactated ringer/s solution at a rate of 125ml/hour after delivery of the placenta.
  • In Tranexamic group (n=111), patients will be given 1 gm (10 ml) TXA (Kapron, Amoun, Egypt) diluted in 20 ml of Glucose 5% (administered as intravenous infusion over 5 minutes, at least 15 minutes prior to skin incision).
  • In Misoprostol group (n=111), 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) will be inserted intraoperative inside the uterus after delivery of the placenta.
  • In carbetocin group (n=111) 100 microgram carbetocin (Pabal, Ferring, Kiel, Germany) will be given as an intravenous bolus dose following the delivery of the placenta.
  • In all groups, patients will additionally receive 5 IU oxytocin given as slow intravenous bolus following delivery of the baby.
  • All cesarean sections will be done under spinal anesthesia by the following operative steps: pfannenstiel incision, transverse lower uterine segment incision, immediate cord clamping (< 30 seconds) and the placenta will be removed by controlled cord traction after its spontaneous separation, closure of uterus in 2 layers, closure of anterior abdominal wall in anatomical manner (adequate hemostasis will be ensured in all operative steps).
  • The number and the difference of weight of operative towels (before and after LSCS) and amount of blood in suction unit will be recorded.
  • Fluid monitoring will be performed through rate of infusion and urine output. A complete blood count test will be performed 12 hours after delivery.
  • Estimated Blood Loss (EBL) will be evaluated as follows:
  • The number of operative towels used.
  • The difference of weight of operative towels (before and after cs) plus the amount of blood in suction unit (we will calculate 1 gram of weight difference equal to 1 ml blood loss).
  • EBL calculation according to the formula which is EBL equals EBV times Preoperative hematocrit minus Postoperative hematocrit divided by Postoperative hematocrit.
  • Where EBV is estimated blood volume of the patient in mL (equals weight in kg × 85).
  • In Tranexamic Acid group (n=111), the time interval between drug administration and fetal delivery will be recorded.
  • All patients will be followed up following the delivery as regard occurrence of primary postpartum hemorrhage (within the first 24 hours), the need for blood transfusion (within the first 24 hours), misoprostol-related side effects (in the first 6 hours) (i.e., shivering, pyrexia >38C0, headache, nausea, vomiting with or without the need for antiemetic drugs), carbetocin - related side effects (i.e., nausea, vomiting, flushing, dizziness, syncope) and the occurrence of thromboembolic events (within one week of delivery).
  • The EBL will be compared among the four groups together with occurrence of the above-mentioned drugs side effects.
Being tested
Tranexamic acid
Medical subject headings
Postpartum Hemorrhage, Postoperative Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic acidDrug

    Also called Misoprostol, Carbetocin, Oxytocin

    Giving oxytocin only, or oxytocin in addition to Tranexamic acid, Misoprostol or Carbetocin the mentioned doses and by the mention routes, then comparing the estimated blood loss in each group.

Study groups in NCT06060327
Study groupRoleWhat they receive
Oxytocin GroupActive comparatoro In Oxytocin group (n=111), patients will receive 10 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) given as infusion in 500 ml lactated ringer/s solution at a rate of 125ml/hour after delivery of the placenta.
Receives: Drug: Tranexamic acid
Tranexamic acidActive comparatoro In Tranexamic group (n=111), patients will be given 1 gm (10 ml) TXA (Kapron, Amoun, Egypt) diluted in 20 ml of Glucose 5% (administered as intravenous infusion over 5 minutes, at least 15 minutes prior to skin incision). Oxytocin 5 IU will be given slowly intravenous following delivery of the baby.
Receives: Drug: Tranexamic acid
MisoprostolActive comparatoro In Misoprostol group (n=111), 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) will be inserted intraoperative inside the uterus after delivery of the placenta Oxytocin 5 IU will be given slowly intravenous following delivery of the baby.
Receives: Drug: Tranexamic acid
CarbetocinActive comparatoro In carbetocin group (n=111) 100 microgram carbetocin (Pabal, Ferring, Kiel, Germany) will be given as an intravenous bolus dose following the delivery of the placenta. Oxytocin 5 IU will be given slowly intravenous following delivery of the baby.
Receives: Drug: Tranexamic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimated Blood Loss

    To compare the estimated blood loss (EBL) during and after cesarean delivery among the four groups.

    Measured: 1 year

Secondary outcomes (3)
  1. Need for additional ecbolics

    The Use of additional ecbolics denoting uterine atony (i.e. 10 IU intravenous infusion of oxytocin with 500 ml lactated ringer at a rate of 125 ml/hour and 1mL [0.2 mg] intramuscular ergometrine with or without 600 microgram rectal misoprostol postoperatively)

    Measured: 1 year

  2. Excessive blood loss and need for blood transfusion

    The occurrence of excessive blood loss (> 1000 mL) together with the need for blood transfusion within the first 24 hours postoperatively.

    Measured: 1 year

  3. Side effects

    The occurrence of any maternal side effects (among the four groups).

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2023
  2. Study start15 Oct 2023
  3. Primary completion15 Jun 2024
  4. Study completion15 Jun 2024

Resources

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 randomized controlled clinical trial including 4 groups comprising of 111 each. Group 1 will receive Oxytocin only, Group 2 will receive Oxytocin and Tranexamic acid, Group 3 will receive Oxytocin and Misoprostol and Group 4 will receive Oxytocin and Carbetocin.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06060327
Sponsor's protocol ID
MD-147-2021
Status last verified
Jul 2024
First submitted
23 Sep 2023
Last updated
23 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen CY, Su YN, Lin TH, Chang Y, Horng HC, Wang PH, Yeh CC, Chang WH, Huang HY. Carbetocin in prevention of postpartum hemorrhage: Experience in a tertiary medical center of Taiwan. Taiwan J Obstet Gynecol. 2016 Dec;55(6):804-809. doi: 10.1016/j.tjog.2016.07.009.

    PubMed 28040124
  • Prata N, Weidert K. Efficacy of misoprostol for the treatment of postpartum hemorrhage: current knowledge and implications for health care planning. Int J Womens Health. 2016 Jul 29;8:341-9. doi: 10.2147/IJWH.S89315. eCollection 2016.

    PubMed 27536161
  • Della Corte L, Saccone G, Locci M, Carbone L, Raffone A, Giampaolino P, Ciardulli A, Berghella V, Zullo F. Tranexamic acid for treatment of primary postpartum hemorrhage after vaginal delivery: a systematic review and meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2020 Mar;33(5):869-874. doi: 10.1080/14767058.2018.1500544. Epub 2018 Sep 10.

    PubMed 30122082

Questions about this trial

What is this clinical trial studying?

A study testing Tranexamic acid in people with Postpartum Hemorrhage and Blood Loss, Postoperative, run by Cairo University at 2 sites 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 11 inclusion and 1 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Estimated Blood Loss (time frame: 1 year). 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 NCT06060327, which also lists 3 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 23 Jul 2024.

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