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Tranexamic Acid Versus Misoprostol in Reducing Blood Loss in Cesarean Section in Primigravida

Primary Purpose

Cesarean Section Complications, Blood Loss, Surgical, Misoprostol

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic acid
Misoprostol 200mcg Tab
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cesarean Section Complications

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women booked for a primary elective cesarean section, not in active labor
  • Aged between 18-40 years.
  • BMI 18.5-29.9 kg/ m2 pre-pregnancy weight
  • Term pregnancies (Early term: between 37 weeks, 0 days and 38 weeks, 6 days. Full term: between 39 weeks, 0 days and 40 weeks, 6 days. Late term: between 41 weeks, 0 days and 41 weeks, 6 days).
  • Singleton pregnancies.
  • Indication of elective cesarean section (Malpresentation, Malposition, Cephalopelvic disproportion, active herpes)
  • Fetal macrosomia (Macrosomia is defined as birth-weight over 4,000 g irrespective of gestational age)
  • Certain congenital fetal malformation and skeletal disorders (Several congenital anomalies are controversial indications for cesarean delivery; these include fetal neural tube defects (to avoid sac rupture), particularly defects that are larger than 5-6 cm in diameter as anterior cystic hygroma vascular sacrococcygeal teratoma, giant omphalocele and hydrocephalus with an enlarged biparietal diameter, and some skeletal dysplasia such as type III osteogenesis imperfecta. (Hamrick et al., 2008)

Exclusion Criteria:

  • Placenta previa.
  • Maternal hypertension and Preeclampsia.
  • Diabetes mellitus.
  • Severe medical disorder (renal or hepatic).
  • Multiple Fibroid uterus.
  • Multiple pregnancies.
  • Polyhydramnios.
  • Previous uterine surgery as myomectomy.
  • Contraindication to spinal anesthesia.
  • Blood coagulopathy and bleeding disorder.
  • Marked maternal anemia (Preoperative hemoglobin <9 gm/dl).
  • Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol) or TXA

Sites / Locations

  • faculty of medicine - Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1: Tranexamic acid group

Group 2: Misoprostol group

Arm Description

100 women: will receive preoperative 1 gram of TXA (kapron®, Amoun, Egypt) 10 minutes before skin incision, by slow intravenous injection over 10 minutes (Tranexamic acid injection will be prepared by diluting 1gm (10ml) TXA in 100 ml. of normal saline. TXA will be administrated as an intravenous infusion or slowly injection) and preoperative placebo (4 tablets similar to misoprostol in size and shape as peroxide) will be administrated rectally.

100 women: will receive preoperative 800 micrograms of misoprostol (4 tablets) rectally after spinal anesthesia and urinary catheterization (as per WHO dose recommendation) (Conde-Agudelo et al., 2013) and preoperative placebo (10 minutes before skin incision, 10 ml of distilled water ampoules by slow intravenous injection over 10 minutes).

Outcomes

Primary Outcome Measures

Blood loss
Estimation of Intraoperative and postoperative blood loss.

Secondary Outcome Measures

Maternal outcome
Need of extra utero-tonic drugs
Maternal outcome
Incidence of postpartum hemorrhage (defined as bleeding >1000 mL during the first 24 hours after the operation)
maternal outcome
Need for blood transfusion
Maternal outcome
Post-operative HB & HTC
Maternal outcome
The incidence of side effects e.g. nausea, vomiting, diarrhea, shivering and headache.
Maternal outcome
Duration of operation
maternal outcome
Time of resuming bowel habits

Full Information

First Posted
November 12, 2020
Last Updated
July 20, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04635007
Brief Title
Tranexamic Acid Versus Misoprostol in Reducing Blood Loss in Cesarean Section in Primigravida
Official Title
The Effect of Pre-operative Intravenous Tranexamic Acid Versus Rectal Misoprostol in Reducing Blood Loss During and After Elective Cesarean Section in Primigravida: A Double-blinded, Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of the work is to compare the efficacy of preoperative IV tranexamic acid and rectal misoprostol in reducing blood loss in the elective cesarean section. Research question: In women undergoing elective cesarean section, is preoperative administration of IV tranexamic acid better than rectal misoprostol in reducing blood loss?
Detailed Description
Type of study: Prospective double-blinded randomized placebo-controlled Clinical trial Time plan: Approximately 12 months according to calculated sample size. study setting: this study will be conducted obstetrics and gynecology department at Cairo University. study population: Patients will be enrolled in this study of those attending the obstetric clinic at kasr el ainy hospital for elective cesarean section. Methodology: Methodology in details: Verbal and written consent will be obtained before history taking All women will be subjected to History taking: Detailed clinical history. Personal history: Name, Age, Parity, Occupation, Residency, and Special habits. -Present history: History of onset, course, and duration of vaginal bleeding or bloody vaginal discharge, presence of uterine contraction, PROM, IUGR, or any indication for cesarean section. -Obstetric history: History of previous abortion. -Menstrual history: For estimation of gestational age using Naegele's rule, provided that she had regular cycles for the last three months before she got pregnant and was not taking contraceptive pills during this period and she was sure of her dates. Term pregnancy defined as delivery between 37 and 42 weeks of gestation. Gestational age will be assessed from the menstrual history and will be confirmed by measurement of fetal crown-rump length at a first-trimester scan. -Past history: History of medical disorders, drug therapy or allergy, or history of intake of other tocolytic drugs. -Family history: For consanguinity in the case of CFMF. Examination Full clinical examination (pulse, temperature, and blood pressure). General examination including blood pressure, heart rate, body temperature, body mass index, head& neck examination, Bilateral lower limb examination, chest, heart. Local clinical examination; assessment of maternal health, obstetric abdominal examination for fundal level, fetal presentation, estimating fetal weight, and scars of previous operations, uterine contraction if present, auscultation of FHR. Preoperative investigations (Rh, CBC, HTC, Hb, Coagulation profile, fasting and postprandial blood sugar, and complete urine analysis). Ultrasonography examination: to assess the following data: Gestational age Fetal viability Fetal presentation and EFW. Detection of any fetal congenital anomalies. To ensure that all inclusion criteria are present. Check amniotic fluid index (the amniotic fluid index (AFI) will be estimated using abdominal ultrasonography on the day of delivery or the day before delivery. The uterus will be divided into four quadrants; the right and left quadrants will be defined by the linea nigra, and the upper and lower quadrants will be defined by the umbilicus. The maximum vertical diameter of amniotic fluid in each quadrant will be measured in centimeters. The sum of these four quadrants will be used to calculate the AFI. The volume of amniotic fluid in ml. will be estimated by multiplying the AFI by 30. Intervention: The cesarean section will be done by a senior registrar who performed at least 300 cesarean sections before the start of the study. All CS will be performed using spinal anesthesia; the abdomen will be entered by Pfannenstiel abdominal incision. The allotted sealed envelope (allocation concealment will be discussed later) will be taken to the theatre and handed over to the anesthetist who will administrate the drug (TXA or Misoprostol) or the placebo to the patient without telling neither the researcher nor the patient the content of the envelope. With the induction of anesthesia, patients assigned to group 1 will receive 1 gram of TXA (kapron®, Amoun, Egypt) 10 minutes before skin incision, by slow intravenous injection over 10 minutes and preoperative placebo (4 tablets similar to misoprostol in size and shape as peroxide) will be administrated rectally. (Tranexamic acid injection will be prepared by diluting 1gm (10ml) TXA in 100 ml of normal saline. Participants are assigned to group 2 will receive 800μg rectal misoprostol (Misotac®, SIGMA, Egypt) immediately after urinary catheterization and before skin incision and preoperative placebo (10 minutes before skin incision, 10 ml of distilled water ampoules or normal saline by slow intravenous injection over 10 minutes). All women will receive 10 IU of oxytocin (syntocinon®, NOVARTIS) by slow intravenous after cord clamping. Sterilization and toweling of the patient then the standard technique of trans-peritoneal lower segment cesarean will be adopted. The placenta will be removed by cord traction and uterine compression. The uterus will be exteriorized and compressed during closure which will be achieved by continuous unlocked sutures in 2 layers using 2/0 polyglactin suture and 1 cm interval between sutures. The peritoneum and muscle will be closed by 2/0 polyglactin suture and the sheath will be closed by 1/0 polyglactin, and the skin will be closed by subcuticular suture using proline double zero suture in both groups. The estimation of blood loss will be started after skin incision. The linen towels will be weighted in (mg) with its cover before and after the operation using a highly accurate digital balance and the difference in weight between dry and soaked linen towels will be calculated. Blood loss during the operation will be calculated as follows: Volume of the contents of the suction bottle (ml) (A). Difference in weight of linen towels (gm) (B) (weight of soaked linen towels (gm) - the weight of dry linen towels (gm)). Amniotic fluid volume (ml) (C). So, blood loss during operation (ml) = (A + B) - C. Allowable blood loss will be calculated for all women according to the underlying law. ABL= EBV x (Hi - Hf) / Hi Hi = initial Hct Hf = final lowest acceptable Hct Estimated Blood Volume (EBV) EBV = weight (kg) X average blood volume (75-85 ml/kg) A trained nurse will be responsible for the collection of wound dressing placed in the vulval area during the first 24 hours after surgery and the difference in weight will be calculated. The overall blood loss will be calculated. The difference between preoperative and 24 hours postoperative in hemoglobin concentration and hematocrit value will be measured to calculate allowable blood loss The need for additional uterotonics drugs will be given according to the attendant consultant decision or a blood loss of more than 1000ml intraoperative. Operative time, need for blood transfusion and side effects of study drug e.g. nausea, vomiting, diarrhea will be recorded. All the patients will receive non-steroidal anti-inflammatory preparation in the form of (Rheumarene®) 75mg IM (one ampoule) immediately postoperative than one ampoule 12 hours postoperative and the need for extra analgesics will be recorded. All the patients will receive prophylactic broad-spectrum antibiotics in form of (Ceftriaxone®, Sandoz, Egypt) 1 gm./12 hours. The Apgar score of the fetus at 1 and 5 minutes, the need for neonatal intensive care unit (NICU) admission, and neonatal death will be assessed in the two groups. Data will be collected, tabulated, and statistically analyzed by IBM computer using the Statistical Package for the Social Sciences (SPSS version 24). Chi-square test will be used to compare qualitative variables between groups and Fisher exact test will be used instead of the Chi-square test when the expected cell count less than 5. The student t-test will be used to compare the quantitative variables in parametric data. P-value <0.05 will be set significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications, Blood Loss, Surgical, Misoprostol, Tranexamic Acid

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The patients will be divided into 2 groups Group no. (1) 100 women: will receive preoperative 1 gram of TXA (kapron®, Amoun, Egypt) 10 minutes before skin incision, by slow intravenous injection over 10 minutes (Tranexamic acid injection will be prepared by diluting 1gm (10ml) TXA in 100 ml. of normal saline. TXA will be administrated as an intravenous infusion or slowly injection) and preoperative placebo (4 tablets similar to misoprostol in size and shape as peroxide) will be administrated rectally. Group no. (2) 100 women: will receive preoperative 800 micrograms of misoprostol (4 tablets) rectally after spinal anesthesia and urinary catheterization (as per WHO dose recommendation) (Conde-Agudelo et al., 2013) and preoperative placebo (10 minutes before skin incision, 10 ml of distilled water ampoules by slow intravenous injection over 10 minutes).
Masking
ParticipantInvestigator
Masking Description
A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment. This procedure is utilized to prevent bias in research results. Double-blind studies are particularly useful for preventing bias due to demand characteristics or the placebo effect. In a double-blind study, the investigators who interact with the participants would not know who will receive the actual drug and who will receive a placebo.
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Tranexamic acid group
Arm Type
Experimental
Arm Description
100 women: will receive preoperative 1 gram of TXA (kapron®, Amoun, Egypt) 10 minutes before skin incision, by slow intravenous injection over 10 minutes (Tranexamic acid injection will be prepared by diluting 1gm (10ml) TXA in 100 ml. of normal saline. TXA will be administrated as an intravenous infusion or slowly injection) and preoperative placebo (4 tablets similar to misoprostol in size and shape as peroxide) will be administrated rectally.
Arm Title
Group 2: Misoprostol group
Arm Type
Experimental
Arm Description
100 women: will receive preoperative 800 micrograms of misoprostol (4 tablets) rectally after spinal anesthesia and urinary catheterization (as per WHO dose recommendation) (Conde-Agudelo et al., 2013) and preoperative placebo (10 minutes before skin incision, 10 ml of distilled water ampoules by slow intravenous injection over 10 minutes).
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
Kapron
Intervention Description
100 women: will receive preoperative 1 gram of TXA (kapron®, Amoun, Egypt) 10 minutes before skin incision, by slow intravenous injection over 10 minutes (Tranexamic acid injection will be prepared by diluting 1gm (10ml) TXA in 100 ml. of normal saline. TXA will be administrated as an intravenous infusion or slowly injection) and preoperative placebo (4 tablets similar to misoprostol in size and shape as peroxide) will be administrated rectally.
Intervention Type
Drug
Intervention Name(s)
Misoprostol 200mcg Tab
Other Intervention Name(s)
Cytotic
Intervention Description
100 women: will receive preoperative 800 micrograms of misoprostol (4 tablets) rectally after spinal anesthesia and urinary catheterization (as per WHO dose recommendation) (Conde-Agudelo et al., 2013) and preoperative placebo (10 minutes before skin incision, 10 ml of distilled water ampoules by slow intravenous injection over 10 minutes).
Primary Outcome Measure Information:
Title
Blood loss
Description
Estimation of Intraoperative and postoperative blood loss.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Maternal outcome
Description
Need of extra utero-tonic drugs
Time Frame
6 hours
Title
Maternal outcome
Description
Incidence of postpartum hemorrhage (defined as bleeding >1000 mL during the first 24 hours after the operation)
Time Frame
24 hours
Title
maternal outcome
Description
Need for blood transfusion
Time Frame
24 hours
Title
Maternal outcome
Description
Post-operative HB & HTC
Time Frame
24 hours
Title
Maternal outcome
Description
The incidence of side effects e.g. nausea, vomiting, diarrhea, shivering and headache.
Time Frame
12 hours
Title
Maternal outcome
Description
Duration of operation
Time Frame
2 hours
Title
maternal outcome
Description
Time of resuming bowel habits
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women booked for a primary elective cesarean section, not in active labor Aged between 18-40 years. BMI 18.5-29.9 kg/ m2 pre-pregnancy weight Term pregnancies (Early term: between 37 weeks, 0 days and 38 weeks, 6 days. Full term: between 39 weeks, 0 days and 40 weeks, 6 days. Late term: between 41 weeks, 0 days and 41 weeks, 6 days). Singleton pregnancies. Indication of elective cesarean section (Malpresentation, Malposition, Cephalopelvic disproportion, active herpes) Fetal macrosomia (Macrosomia is defined as birth-weight over 4,000 g irrespective of gestational age) Certain congenital fetal malformation and skeletal disorders (Several congenital anomalies are controversial indications for cesarean delivery; these include fetal neural tube defects (to avoid sac rupture), particularly defects that are larger than 5-6 cm in diameter as anterior cystic hygroma vascular sacrococcygeal teratoma, giant omphalocele and hydrocephalus with an enlarged biparietal diameter, and some skeletal dysplasia such as type III osteogenesis imperfecta. (Hamrick et al., 2008) Exclusion Criteria: Placenta previa. Maternal hypertension and Preeclampsia. Diabetes mellitus. Severe medical disorder (renal or hepatic). Multiple Fibroid uterus. Multiple pregnancies. Polyhydramnios. Previous uterine surgery as myomectomy. Contraindication to spinal anesthesia. Blood coagulopathy and bleeding disorder. Marked maternal anemia (Preoperative hemoglobin <9 gm/dl). Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol) or TXA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed A Taymour, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of medicine - Cairo university
City
Cairo
State/Province
Kasr El Ainy
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

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Tranexamic Acid Versus Misoprostol in Reducing Blood Loss in Cesarean Section in Primigravida

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