Tranexamic Acid Versus Misoprostol to Reduce Blood Loss During and After Cesarean Section
Comparison of the Effect of Tranexamic Acid Versus Misoprostol on Blood Loss During and After Cesarean Section
Brief Summary
The goal of this clinical trial is to compare two medicines, intravenous tranexamic acid and rectal misoprostol, for reducing blood loss in women undergoing cesarean section. The study will also compare how much hemoglobin (a measure of blood loss) decreases after surgery with each treatment.
The main questions the study aims to answer are:
- Does intravenous tranexamic acid reduce the drop in hemoglobin more than rectal misoprostol after cesarean section?
- Does intravenous tranexamic acid reduce blood loss during and within 2 hours after cesarean section more than rectal misoprostol?
Researchers will randomly assign 214 women scheduled for cesarean section to receive either intravenous tranexamic acid or rectal misoprostol before surgery. All cesarean sections will be performed according to the hospital's standard procedures by experienced obstetricians.
Participants will:
i. Be randomly assigned to receive either intravenous tranexamic acid or rectal misoprostol before surgery.
ii. Have their hemoglobin level measured before the cesarean section and again 2 hours after surgery.
iii. Have blood loss measured during the operation and for 2 hours after surgery.
iv. Have the duration of the operation recorded as part of the study.
The results will help determine which treatment is more effective in reducing blood loss and preserving hemoglobin levels during and after cesarean section.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
Punjab Province
-
Multan, Punjab Province, Pakistan, 60000
- Medicare Hospital (Pvt) Limited
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- 37 to 42 weeks of gestation
- Planned cesarean section
Exclusion Criteria:
- Women with pre-eclampsia
- Chronic hypertension
- Multiple pregnancies
- Preterm or postdate pregnancy
- Previous cesarean section
- Gestational diabetes
- Fetal macrosomia
- History of bleeding / clotting disorder
- On anti-coagulation heparin / warfarin therapy
- Non-reassuring cardiotocograph or poor progress of labor
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intravenous Tranexamic Acid
Participants will receive intravenous tranexamic acid
|
1000 mg of intravenous tranexamic acid will be given after spinal anesthesia and before start of cesarean section
|
|
Aktiv komparator: Rectal Misoprostol
Participants will receive rectal Misoprostol
|
1000 μg of rectal misoprostol will be given after spinal anesthesia and before start of cesarean section
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Reduction in Hemoglobin
Tidsramme: Baseline at enrollment and postoperative within 2 hours
|
Reduction in hemoglobin will be calculated as the difference between preoperative and 2-hour postoperative hemoglobin concentrations (g/dL).
|
Baseline at enrollment and postoperative within 2 hours
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Blood Loss
Tidsramme: From the start of cesarean section to postoperatively until two hours
|
Total blood loss will be measured as the sum of blood collected in the suction container during surgery and blood absorbed by pre-weighed surgical gauze and sanitary pads (1 g = 1 mL) from the start of surgery until 2 hours after cesarean section.
|
From the start of cesarean section to postoperatively until two hours
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Shahid I Rao, FCPS, Medicare Hospital (Pvt) Limited
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- U1111-1343-7865
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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