xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06010368</url>
    </required_header>
    <id_info>
      <org_study_id>AN2023-3</org_study_id>
      <nct_id>NCT06010368</nct_id>
    </id_info>
    <brief_title>Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section</brief_title>
    <official_title>The Effect of Intramyometrial Tranexamic Acid Versus Intramyometrial Oxytocin in Reducing Blood Loss During and After Elective Cesarean Section in Term Primigravida: A Double-blinded, Randomized, Comparative-placebo Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Cesarean section is the most prevalent operation among women globally, 10-15% (1, 2). Recent&#xD;
        research has shown Egypt to be the third-largest country globally, with an estimated 52%&#xD;
        cesarean sections (3). However, the cesarean section has many serious complications,&#xD;
        including the primary postpartum hemorrhage (PPH) (4). During labor, the average blood loss&#xD;
        is about 300 to 400 ml. Bleeding postpartum is known as losing over five hundred milliliter&#xD;
        of blood following a vaginal birth and losing over one thousand milliliter after the cesarean&#xD;
        section (5). The prime cause of maternal death rate is postpartum bleeding, predominately in&#xD;
        poor countries, and the estimated mortality number due to postpartum bleeding is one hundred&#xD;
        thousand per year (6). Therefore, it is essential to reduce bleeding during and after CS to&#xD;
        diminish maternal mortality and morbidity (7). The most successful technique for decreasing&#xD;
        PPH is the active third stage labor management, requiring prophylactic uterotonic drugs like&#xD;
        oxytocin, ergometrine malate, prostaglandins (E1, E2, and F2α), and combinations of them, or&#xD;
        hemostatic agent as tranexamic acid (Kapron) and Etamsylate (Dicynon) (8, 9).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study design: This study is a double-blinded prospective randomized comparative Clinical&#xD;
        trial to compare and evaluate the effectiveness of intra-myometrial oxytocin injection and&#xD;
        intra-myometrial tranexamic acid injection in reducing the risk of postpartum bleeding after&#xD;
        cesarean delivery in primigravida at term. The study will be conducted in the kasr Al-Ainy&#xD;
        hospital, Maternity hospital, Cairo University, Cairo, Egypt, during October 2021 to October&#xD;
        2022. After The Ethical Research Committee approval on study protocol, fifty primigravida&#xD;
        women at term pregnancy, undergoing elective cesarean delivery will be divided and allocated&#xD;
        randomly into two groups after fulfillment eligibility criteria. Fifty women will be included&#xD;
        in this clinical study at admission to the labor ward. Written informed permission will be&#xD;
        acquired following advising about this study and potential implications. A history in details&#xD;
        and clinical examination for all patients to rule out general health problems. Vaginal and&#xD;
        Abdominal examinations will be done. Routine preoperative investigations and obstetric&#xD;
        ultrasound examinations will be done for all women to ensure that all inclusion criteria were&#xD;
        present. The computer will be used for randomization to allocate the patients into two equal&#xD;
        groups. Randomization cards will be produced, sealed and stored; sequentially black wrappers&#xD;
        will be numbered. The hospital pharmacy is producing packages, and physicians and nurses were&#xD;
        unaware of their contents. For the entire length of the trial, all study personnel and&#xD;
        participants are blinded to therapy. A senior registrar will execute a cesarean section&#xD;
        before the commencement of research, which performs at least 300 cesarean sections. All&#xD;
        cesarean section will be operated via spinal anesthesia; the abdomen will be entered through&#xD;
        the Pfannenstiel incision. The sealed envelope is carried to the operating room and&#xD;
        transferred without informing the researcher or the patients about their contents. The&#xD;
        anesthesiologist is administering the medication (Oxytocin or tranexamic acid). After fetal&#xD;
        birth and before placental delivery, patients assigned to the oxytocin group (n = 25): 5 I.U&#xD;
        of oxytocin (syntocinone 5 I.U/1ML NONARTIS-EGYPT) shall be watered down in 10 cc of saline,&#xD;
        and 5 cc shall be injected into each uterine corn before the placental separation. In TXA&#xD;
        group (n=25): 1 g from tranexamic acid (kapron®, Amoun, Egypt) shall also be watered down in&#xD;
        10 cc of Saline, and 5 cc shall be injected in each uterine corn before the placenta is&#xD;
        separated. The primary outcome is to decrease Intra and postoperative blood loss to reduce&#xD;
        PPH risk after CS. After a skin incision, the estimated blood loss would begin. The towels&#xD;
        are weighted in (mg) with their covers, using an exact digital balance, before and following&#xD;
        the operation, and the weight variation is measured between dryish and saturated towels.&#xD;
        Blood loss is counted as follows during the operation: volume contents in the suction&#xD;
        container in (ml) (X), the towel weight variation in (gm), (Y) (weight of saturated towels in&#xD;
        (gm) - weight of dry towel in (gm)), the amniotic liquid amount in (ml) (Z). Operational&#xD;
        blood loss in (ml) = (X+Y) - Z (18). All women are calculated according to the underlying law&#xD;
        for permissible blood loss. Allowable blood loss = The estimated volume of blood x (initial&#xD;
        hematocrit - final lowest acceptable hematocrit)/ initial hematocrit, an estimated volume of&#xD;
        blood = weight of the patient in (kg) multiplies by average volume of blood (75-85 ml/kg)&#xD;
        (19).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>patients assigned to the oxytocin group (n = 25): 5 I.U of oxytocin (syntocinone 5 I.U/1ML NONARTIS-EGYPT) shall be watered down in 10 cc of saline, and 5 cc shall be injected into each uterine corn before the placental separation. In TXA group (n=25): 1 g from tranexamic acid (kapron®, Amoun, Egypt) shall also be watered down in 10 cc of Saline, and 5 cc shall be injected in each uterine corn before the placenta is separated.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <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.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Blood loss</measure>
      <time_frame>24 hours</time_frame>
      <description>Estimation of Intraoperative and postoperative blood loss.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Need of extra utero-tonic drugs</measure>
      <time_frame>2 hours</time_frame>
      <description>Need of extra utero-tonic drugs</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Cesarean Section Complications</condition>
    <condition>Tranexamic Acid</condition>
    <condition>Oxytocin</condition>
    <condition>Post Partum Hemorrhage</condition>
    <arm_group>
      <arm_group_label>Group 1: Tranexamic acid group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In TXA group (n=25): 1 g from tranexamic acid (kapron®, Amoun, Egypt) shall also be watered down in 10 cc of Saline, and 5 cc shall be injected in each uterine corn before the placenta is separated.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2: oxytocin group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>to the oxytocin group (n = 25): 5 I.U of oxytocin (syntocinone 5 I.U/1ML NONARTIS-EGYPT) shall be watered down in 10 cc of saline, and 5 cc shall be injected into each uterine corn before the placental separation</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tranexamic acid injection</intervention_name>
      <description>In TXA group (n=25): 1 g from tranexamic acid (kapron®, Amoun, Egypt) shall also be watered down in 10 cc of Saline, and 5 cc shall be injected in each uterine corn before the placenta is separated.</description>
      <arm_group_label>Group 1: Tranexamic acid group</arm_group_label>
      <other_name>kapron</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oxytocin</intervention_name>
      <description>the oxytocin group (n = 25): 5 I.U of oxytocin (syntocinone 5 I.U/1ML NONARTIS-EGYPT) shall be watered down in 10 cc of saline, and 5 cc shall be injected into each uterine corn before the placental separation</description>
      <arm_group_label>Group 2: oxytocin group</arm_group_label>
      <other_name>syntocinone</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          nclusion Criteria:&#xD;
  &#xD;
            -  Women booked for a primary elective cesarean section, not in active labor&#xD;
  &#xD;
            -  Aged between 20-40 years.&#xD;
  &#xD;
            -  BMI 18.5-29.9 kg/ m2 pre-pregnancy weight&#xD;
  &#xD;
            -  Term pregnancies (Early term: between 37 weeks, 0 days and 38 weeks, 6 days. Full&#xD;
               term: between 39 weeks, 0 days and 40 weeks, 6 days. Late term: between 41 weeks, 0&#xD;
               days and 41 weeks, 6 days).&#xD;
  &#xD;
            -  Singleton pregnancies.&#xD;
  &#xD;
            -  Indication of elective cesarean section (Malpresentation, Malposition, Cephalopelvic&#xD;
               disproportion, active herpes)&#xD;
  &#xD;
            -  Fetal macrosomia (Macrosomia is defined as birth-weight over 4,000 g irrespective of&#xD;
               gestational age)&#xD;
  &#xD;
            -  Certain congenital fetal malformation and skeletal disorders (Several congenital&#xD;
               anomalies are controversial indications for cesarean delivery; these include fetal&#xD;
               neural tube defects (to avoid sac rupture), particularly defects that are larger than&#xD;
               5-6 cm in diameter as anterior cystic hygroma vascular sacrococcygeal teratoma, giant&#xD;
               omphalocele and hydrocephalus with an enlarged biparietal diameter, and some skeletal&#xD;
               dysplasia such as type III osteogenesis imperfecta. (Hamrick et al., 2008)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Placenta previa.&#xD;
  &#xD;
            -  Maternal hypertension and Preeclampsia.&#xD;
  &#xD;
            -  Diabetes mellitus.&#xD;
  &#xD;
            -  Severe medical disorder (renal or hepatic).&#xD;
  &#xD;
            -  Multiple Fibroid uterus.&#xD;
  &#xD;
            -  Multiple pregnancies.&#xD;
  &#xD;
            -  Polyhydramnios.&#xD;
  &#xD;
            -  Previous uterine surgery as myomectomy.&#xD;
  &#xD;
            -  Contraindication to spinal anesthesia.&#xD;
  &#xD;
            -  Blood coagulopathy and bleeding disorder.&#xD;
  &#xD;
            -  Marked maternal anemia (Preoperative hemoglobin &lt;9 gm/dl).&#xD;
  &#xD;
            -  Contraindications to TXA or oxytocin therapy (e.g. allergy)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mohammed A Taymour, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>waleed M El-khayat, MD</last_name>
      <phone>01005135542</phone>
      <email>waleed_elkhyat@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>faculty of medicine - Cairo university</name>
        <address>
          <city>Cairo</city>
          <state>Kasr El Ainy</state>
          <zip>11562</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>mohamed T aneis, MD</last_name>
        <phone>202 23653269</phone>
      </contact>
      <investigator>
        <last_name>waleed M El khyat, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>El-Zanati FJICAfPM, Economic SRib, Knowledge SJU, B PoH. Egypt Health Issues Survey, Ministry of Health and Population, El-Zanaty and Associates and, ICF International. 2015:25-50.</citation>
    </reference>
    <reference>
      <citation>Kebede BA, Abdo RA, Anshebo AA, Gebremariam BM. Prevalence and predictors of primary postpartum hemorrhage: An implication for designing effective intervention at selected hospitals, Southern Ethiopia. PLoS One. 2019 Oct 31;14(10):e0224579. doi: 10.1371/journal.pone.0224579. eCollection 2019.</citation>
      <PMID>31671143</PMID>
    </reference>
    <reference>
      <citation>Brun R, Spoerri E, Schaffer L, Zimmermann R, Haslinger C. Induction of labor and postpartum blood loss. BMC Pregnancy Childbirth. 2019 Jul 25;19(1):265. doi: 10.1186/s12884-019-2410-8.</citation>
      <PMID>31345178</PMID>
    </reference>
    <results_reference>
      <citation>Visconti F, Quaresima P, Rania E, Palumbo AR, Micieli M, Zullo F, Venturella R, Di Carlo C. Difficult caesarean section: A literature review. Eur J Obstet Gynecol Reprod Biol. 2020 Mar;246:72-78. doi: 10.1016/j.ejogrb.2019.12.026. Epub 2020 Jan 7.</citation>
      <PMID>31962259</PMID>
    </results_reference>
    <results_reference>
      <citation>Boerma T, Ronsmans C, Melesse DY, Barros AJD, Barros FC, Juan L, Moller AB, Say L, Hosseinpoor AR, Yi M, de Lyra Rabello Neto D, Temmerman M. Global epidemiology of use of and disparities in caesarean sections. Lancet. 2018 Oct 13;392(10155):1341-1348. doi: 10.1016/S0140-6736(18)31928-7.</citation>
      <PMID>30322584</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>ahmed nagy shaker ramadan</investigator_full_name>
      <investigator_title>Assistant lecturer of obstetrics and gynecology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Postpartum Hemorrhage</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tranexamic Acid</mesh_term>
      <mesh_term>Oxytocin</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06010368
  org study id: AN2023-3
  nct id: NCT06010368
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Cesarean section is the most prevalent operation among women globally, 10-15% (1, 2). Recent
        research has shown Egypt to be the third-largest country globally, with an estimated 52%
        cesarean sections (3). However, the cesarean section has many serious complications,
        including the primary postpartum hemorrhage (PPH) (4). During labor, the average blood loss
        is about 300 to 400 ml. Bleeding postpartum is known as losing over five hundred milliliter
        of blood following a vaginal birth and losing over one thousand milliliter after the cesarean
        section (5). The prime cause of maternal death rate is postpartum bleeding, predominately in
        poor countries, and the estimated mortality number due to postpartum bleeding is one hundred
        thousand per year (6). Therefore, it is essential to reduce bleeding during and after CS to
        diminish maternal mortality and morbidity (7). The most successful technique for decreasing
        PPH is the active third stage labor management, requiring prophylactic uterotonic drugs like
        oxytocin, ergometrine malate, prostaglandins (E1, E2, and F2α), and combinations of them, or
        hemostatic agent as tranexamic acid (Kapron) and Etamsylate (Dicynon) (8, 9).
  Study design: This study is a double-blinded prospective randomized comparative Clinical
        trial to compare and evaluate the effectiveness of intra-myometrial oxytocin injection and
        intra-myometrial tranexamic acid injection in reducing the risk of postpartum bleeding after
        cesarean delivery in primigravida at term. The study will be conducted in the kasr Al-Ainy
        hospital, Maternity hospital, Cairo University, Cairo, Egypt, during October 2021 to October
        2022. After The Ethical Research Committee approval on study protocol, fifty primigravida
        women at term pregnancy, undergoing elective cesarean delivery will be divided and allocated
        randomly into two groups after fulfillment eligibility criteria. Fifty women will be included
        in this clinical study at admission to the labor ward. Written informed permission will be
        acquired following advising about this study and potential implications. A history in details
        and clinical examination for all patients to rule out general health problems. Vaginal and
        Abdominal examinations will be done. Routine preoperative investigations and obstetric
        ultrasound examinations will be done for all women to ensure that all inclusion criteria were
        present. The computer will be used for randomization to allocate the patients into two equal
        groups. Randomization cards will be produced, sealed and stored; sequentially black wrappers
        will be numbered. The hospital pharmacy is producing packages, and physicians and nurses were
        unaware of their contents. For the entire length of the trial, all study personnel and
        participants are blinded to therapy. A senior registrar will execute a cesarean section
        before the commencement of research, which performs at least 300 cesarean sections. All
        cesarean section will be operated via spinal anesthesia; the abdomen will be entered through
        the Pfannenstiel incision. The sealed envelope is carried to the operating room and
        transferred without informing the researcher or the patients about their contents. The
        anesthesiologist is administering the medication (Oxytocin or tranexamic acid). After fetal
        birth and before placental delivery, patients assigned to the oxytocin group (n = 25): 5 I.U
        of oxytocin (syntocinone 5 I.U/1ML NONARTIS-EGYPT) shall be watered down in 10 cc of saline,
        and 5 cc shall be injected into each uterine corn before the placental separation. In TXA
        group (n=25): 1 g from tranexamic acid (kapron®, Amoun, Egypt) shall also be watered down in
        10 cc of Saline, and 5 cc shall be injected in each uterine corn before the placenta is
        separated. The primary outcome is to decrease Intra and postoperative blood loss to reduce
        PPH risk after CS. After a skin incision, the estimated blood loss would begin. The towels
        are weighted in (mg) with their covers, using an exact digital balance, before and following
        the operation, and the weight variation is measured between dryish and saturated towels.
        Blood loss is counted as follows during the operation: volume contents in the suction
        container in (ml) (X), the towel weight variation in (gm), (Y) (weight of saturated towels in
        (gm) - weight of dry towel in (gm)), the amniotic liquid amount in (ml) (Z). Operational
        blood loss in (ml) = (X+Y) - Z (18). All women are calculated according to the underlying law
        for permissible blood loss. Allowable blood loss = The estimated volume of blood x (initial
        hematocrit - final lowest acceptable hematocrit)/ initial hematocrit, an estimated volume of
        blood = weight of the patient in (kg) multiplies by average volume of blood (75-85 ml/kg)
        (19).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: patients assigned to the oxytocin group (n = 25): 5 I.U of oxytocin (syntocinone 5 I.U/1ML NONARTIS-EGYPT) shall be watered down in 10 cc of saline, and 5 cc shall be injected into each uterine corn before the placental separation. In TXA group (n=25): 1 g from tranexamic acid (kapron®, Amoun, Egypt) shall also be watered down in 10 cc of Saline, and 5 cc shall be injected in each uterine corn before the placenta is separated.
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  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.
  measure: Blood loss
  time frame: 24 hours
  description: Estimation of Intraoperative and postoperative blood loss.
  measure: Need of extra utero-tonic drugs
  time frame: 2 hours
  description: Need of extra utero-tonic drugs
  arm group label: Group 1: Tranexamic acid group
  arm group type: Experimental
  description: In TXA group (n=25): 1 g from tranexamic acid (kapron®, Amoun, Egypt) shall also be watered down in 10 cc of Saline, and 5 cc shall be injected in each uterine corn before the placenta is separated.
  arm group label: Group 2: oxytocin group
  arm group type: Experimental
  description: to the oxytocin group (n = 25): 5 I.U of oxytocin (syntocinone 5 I.U/1ML NONARTIS-EGYPT) shall be watered down in 10 cc of saline, and 5 cc shall be injected into each uterine corn before the placental separation
  intervention type: Drug
  intervention name: Tranexamic acid injection
  description: In TXA group (n=25): 1 g from tranexamic acid (kapron®, Amoun, Egypt) shall also be watered down in 10 cc of Saline, and 5 cc shall be injected in each uterine corn before the placenta is separated.
  arm group label: Group 1: Tranexamic acid group
  other name: kapron
  intervention type: Drug
  intervention name: Oxytocin
  description: the oxytocin group (n = 25): 5 I.U of oxytocin (syntocinone 5 I.U/1ML NONARTIS-EGYPT) shall be watered down in 10 cc of saline, and 5 cc shall be injected into each uterine corn before the placental separation
  arm group label: Group 2: oxytocin group
  other name: syntocinone
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Mohammed A Taymour, MD
  role: Principal Investigator
  affiliation: Cairo University
  last name: waleed M El-khayat, MD
  phone: 01005135542
  email: waleed_elkhyat@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Egypt
  citation: El-Zanati FJICAfPM, Economic SRib, Knowledge SJU, B PoH. Egypt Health Issues Survey, Ministry of Health and Population, El-Zanaty and Associates and, ICF International. 2015:25-50.
  citation: Kebede BA, Abdo RA, Anshebo AA, Gebremariam BM. Prevalence and predictors of primary postpartum hemorrhage: An implication for designing effective intervention at selected hospitals, Southern Ethiopia. PLoS One. 2019 Oct 31;14(10):e0224579. doi: 10.1371/journal.pone.0224579. eCollection 2019.
  PMID: 31671143
  citation: Brun R, Spoerri E, Schaffer L, Zimmermann R, Haslinger C. Induction of labor and postpartum blood loss. BMC Pregnancy Childbirth. 2019 Jul 25;19(1):265. doi: 10.1186/s12884-019-2410-8.
  PMID: 31345178
  citation: Visconti F, Quaresima P, Rania E, Palumbo AR, Micieli M, Zullo F, Venturella R, Di Carlo C. Difficult caesarean section: A literature review. Eur J Obstet Gynecol Reprod Biol. 2020 Mar;246:72-78. doi: 10.1016/j.ejogrb.2019.12.026. Epub 2020 Jan 7.
  PMID: 31962259
  citation: Boerma T, Ronsmans C, Melesse DY, Barros AJD, Barros FC, Juan L, Moller AB, Say L, Hosseinpoor AR, Yi M, de Lyra Rabello Neto D, Temmerman M. Global epidemiology of use of and disparities in caesarean sections. Lancet. 2018 Oct 13;392(10155):1341-1348. doi: 10.1016/S0140-6736(18)31928-7.
  PMID: 30322584
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: ahmed nagy shaker ramadan
  investigator title: Assistant lecturer of obstetrics and gynecology
  mesh term: Postpartum Hemorrhage
  mesh term: Hemorrhage
  mesh term: Tranexamic Acid
  mesh term: Oxytocin