Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201910644489698 Date of Approval: 17/10/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Tranexamic acid versus Misoprostol in reducing blood loss during cesarean section: a cross-sectional comparative study in Abakaliki, Nigeria
Official scientific title Tranexamic acid versus Misoprostol in reducing blood loss during cesarean section: a cross-sectional comparative study in Abakaliki, Nigeria
Brief summary describing the background and objectives of the trial Every year, over half a million women die of pregnancy-related causes, about one-quarter of these women die due to primary postpartum hemorrhage (PPH); maternal demise can occur within 2-4 hours of the onset of bleeding thus making PPH not only the most dangerous obstetric complication but also the fastest route to maternal death. Majority of these deaths occur in developing regions of the world where maternal health care provision and utilization is lowest. Cesarean section (CS) is one of the major surgery performed on women worldwide. Its rate is increasing both in developed and in developing countries. It is associated with bleeding morbidities and mortality especially in developing countries due to poor access to health care, lack of blood for transfusion and refusal to receive blood. Patients who undergo cesarean section are at increased risk of developing PPH. Uterine atony is the commonest cause of obstetric hemorrhage during vaginal delivery and cesarean section. The use of oxytocin in prevention of uterine atony has been recommended for every woman in third stage of labor. However, despite the routine use of oxytocin as recommended by the WHO, 10-40% of women still need secondary uterotonics such as prostaglandin analogs and these have been used to reduce blood loss during cesarean section. Misoprostol, in recent times, has been recommended as first-line drug in the prevention of excessive postpartum blood loss in many developing countries due to its multiple routes of administration, its stability to temperature changes, availability, and cost. However, trauma during cesarean section provokes fibrinolysis and the use of antifibrinolytics, therefore, has been suggested to prevent excessive blood loss due to fibrinolysis during cesarean section. Antifibrinolytics is known to reduce the incidence of postoperative blood transfusion and its attendant complications through platelet plugs at injured sites and placenta bed. The Clinical Randomization of an Anti-
Type of trial RCT
Acronym (If the trial has an acronym then please provide) none
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2017
Actual trial start date 01/04/2017
Anticipated date of last follow up 30/10/2017
Actual Last follow-up date 01/01/2018
Anticipated target sample size (number of participants) 358
Actual target sample size (number of participants) 358
Recruitment status Completed
Publication URL none
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Misoprostol rectal misoprostol 1000μg after spinnal anaesthesia six months Women randomized to the misoprostol group received 1000μg of pre-operative rectal misoprostol after spinal anesthesia. The surgeries were done by senior registrars and/or consultants. A Pfannenstiel abdominal incision was used for the cesarean section. Transverse lower segment incision was used to deliver the fetus and the uterus was repaired in two layers using Vicryl 2. The anterior abdominal wall was closed in layers using Vicryl 2 to the rectus sheath, Vicryl 2/0 to the peritoneum, muscle, and subcutaneous layer. The skin was closed subcutaneously using Vicryl 2/0. The blood loss was estimated using abdominal mop. A uniform 25cm×25cm abdominal mop was used during surgeries. The dry weighed of the mop was 55g gotten using a spiral spring scale calibrated in grams (0 – 1200 grams). The abdominal mops were used to dab all the bleeding during the surgery making sure that the mops did not soak up amniotic fluid. After the surgeries, the abdominal mops were gathered into a uniform cellophane bag and hung on the hook of the scale and read directly from the calibration making effort to avoid the error of parallax. The net weight of the mops was recorded after subtracting the weight of the dry mops. The weight of the cellophane was insignificant and was not detected with our scale. Each unit weight gain in grams is equivalent to 1milliliter of blood loss. The estimation was done for each and every one of the patient and recorded for the two groups. To serve as a control and to incorporate post-operative hemoglobin estimation, blood loss was estimated from a modification of the Gross formula given below: Blood loss = BV [Hct (i) - Hct (f)]/ Hct (m) Where BV was the blood volume calculated from the Body Weight (Blood Volume=Body Weight in kilograms x 70 ml) Hct (i), Hct (f) and Hct (m) were the initial, final and mean (of the initial and final) Hematocrits r 179 Active-Treatment of Control Group
Experimental Group tranexamic acid 1000mg 6 months Women randomized to the tranexamic acid group received 1000mg intravenous tranexamic acid after spinal anesthesia. The surgeries were done by senior registrars and/or consultants. A Pfannenstiel abdominal incision was used for the cesarean section. Transverse lower segment incision was used to deliver the fetus and the uterus was repaired in two layers using Vicryl 2. The anterior abdominal wall was closed in layers using Vicryl 2 to the rectus sheath, Vicryl 2/0 to the peritoneum, muscle, and subcutaneous layer. The skin was closed subcutaneously using Vicryl 2/0. The blood loss was estimated using abdominal mop. A uniform 25cm×25cm abdominal mop was used during surgeries. The dry weighed of the mop was 55g gotten using a spiral spring scale calibrated in grams (0 – 1200 grams). The abdominal mops were used to dab all the bleeding during the surgery making sure that the mops did not soak up amniotic fluid. After the surgeries, the abdominal mops were gathered into a uniform cellophane bag and hung on the hook of the scale and read directly from the calibration making effort to avoid the error of parallax. The net weight of the mops was recorded after subtracting the weight of the dry mops. The weight of the cellophane was insignificant and was not detected with our scale. Each unit weight gain in grams is equivalent to 1milliliter of blood loss. The estimation was done for each and every one of the patient and recorded for the two groups. To serve as a control and to incorporate post-operative hemoglobin estimation, blood loss was estimated from a modification of the Gross formula given below: Blood loss = BV [Hct (i) - Hct (f)]/ Hct (m) Where BV was the blood volume calculated from the Body Weight (Blood Volume=Body Weight in kilograms x 70 ml) Hct (i), Hct (f) and Hct (m) were the initial, final and mean (of the initial and final) Hematocrits r 179
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Booked women Elective cesearean section Previous cesarean section Hypertensive disorders of pregnancy Known allergy to misoprostol or tranexamic acid Antepartum haemorrhage Emergency caesarean section Bleeding disorder Adult: 19 Year-44 Year 19 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/04/2017 health research and ethics committee
Ethics Committee Address
Street address City Postal code Country
48 ejiofor street abakaliki abakaliki 480321 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome: Quantity of blood loss during ceserean section During surgery
Secondary Outcome Secondary outcome: Need for blood transfusion Need for additional intervention to control blood loss Change in haemoglobin concentration 48hours after surgery Change systemic blood pressure 4 hours after surgery During surgery, 4 to 48 hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Teaching Hospital Abakaliki Ebonyi state Nigeria 48 Ejiofor street Abakaliki Abakaliki 480231 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Christian O OGAH No 4 Ejiofor street Abakaliki 480321 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Christian O OGAH 48 ejiofor street abakaliki abakaliki 480321 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Chidi OU Esike No 6 Ezike street Abakaliki 480321 Nigeria
Ikechukwu Benedict Okechukwu DIMEJESI No 2 Nwodo street Abakaliki 480321 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ogah christian okechukwu okeyogah2@gmail.com +2347035265123 48 Ejiofor street, Abakaliki
City Postal code Country Position/Affiliation
abakaliki 480321 Nigeria post part 2 senior registrar department of OBYGN abakaliki
Role Name Email Phone Street address
Public Enquiries anikwe chidebe christian drchideanikwechristian@gmail.com +2348064165965 48 ejiofor street
City Postal code Country Position/Affiliation
abakaliki 480321 Nigeria consultant dept of OBYGN abakaliki
Role Name Email Phone Street address
Scientific Enquiries Chidi OU Esike drchidiesike@yahoo.com +2348035004495 6 Esike street
City Postal code Country Position/Affiliation
abakaliki 480321 Nigeria consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the result reported in the article after deidentification ( text , tables,figures) Study Protocol Beginning 9 months to end at 36 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes The maternal demographic and obstetrics factors and blood loss determinants like bedside clotting time, duration of surgery and cadre of surgeon during cesarean section were statistically non-significant between the two groups. Mean intraoperative blood loss was not significantly different between the misoprostol group and tranexamic acid group (547 ± 183.75ml vs. 551.66 ± 21.74ml, P = 0.519). The mean difference in PCV changes was not significant between the groups (2.41±0.95% vs. 2.29±0.56%, P = 0.463). Side effect profile was similar for both groups except shivering which was statistically higher among the misoprostol group compared to the tranexamic acid group (RR = 0.70; 95%CI 0.40 - 0.91, P = 0.028). From this study, tranexamic acid was comparable to misoprostol in the reduction of blood loss during cesarean section. Therefore, tranexamic acid could act as a good alternative to misoprostol for prophylaxis for blood loss during elective cesarean section. 08/10/2019 08/10/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks none
Changes to trial information