Protocol summary
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Study aim
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Comparison of postpartum hemorrhage in three groups receiving oxytocin, sublingual misoprostol and intrauterine misoprostol
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Design
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Clinical trial without control group, with parallel groups, double-blind, randomized, phase 2 on 237 patients. Excel software rand function was used for randomization.
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Settings and conduct
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Sequences of the intervention groups will be provided for the operating room in matte envelopes, and When the cesarean section is started, it will be opened by the nurse cooperating in the study. All participants and surgeons will be unaware of the grouping of the participants before the time of the intervention. Intervention will be applied in the operating room after placental abruption to all three groups
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Participants/Inclusion and exclusion criteria
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Pregnant women between the ages of 18 and 40 with a term pregnancy will be included in the study if they have a history of cesarean section and will be excluded from the study if they have coagulation problems and multiple pregnancies.
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Intervention groups
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Intervention group 1: Oxytocin 10 units (inside 500 cc of Ringer serum) and sublingual misoprostol tablets of 400 micrograms (after placental abruption and uterine correction are inserted in the patient's sublingual and controlled by anesthesia technician to prevent suffocation)
Intervention group 2: Oxytocin recipient 10 units (inside 500 cc of Ringer serum) and intrauterine misoprostol tablet of 400 micrograms (after placental abruption and uterine correction, it is inserted in two uterine poles - 200 micrograms in each cornea)
Intervention group 3: Oxytocin receptor 30 units (within 500 cc of Ringer serum)
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Main outcome variables
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Bleeding volume during cesarean section and within 24 hours after surgery; Drug side effects and duration of surgery
General information
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Reason for update
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Confirmation of the registration date of the randomized clinical trial in the Iranian Clinical Trials Registry (IRCT) and the date of registration of the first patient.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100429003833N2
Registration date:
2021-10-02, 1400/07/10
Registration timing:
prospective
Last update:
2023-07-31, 1402/05/09
Update count:
1
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Registration date
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2021-10-02, 1400/07/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-10-23, 1400/08/01
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Expected recruitment end date
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2022-10-23, 1401/08/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effects of misoprostol and oxytocine on postpartum Hemorrhage
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Public title
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Comparison of the effects of misoprostol and oxytocine on postpartum Hemorrhage
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
singleton pregnant women
elective cesarean delivery
Maximum history of once cesarean section
Exclusion criteria:
Preeclampsia
Cardiovascular diseases
Uterine myoma
A history of excessive bleeding after delivery.
Underlying disease, such as coagulopathy
Abnormal placental implantation (Placenta peria or Ecrta)
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
237
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, patients will be divided into three groups using a table of random numbers. This table contains the numbers 1 to 237 irregularly and without a specific pattern. To prepare this table, the site https://www.Randomization.com will be used. Numbers will be read by default (up, down, left or right). Then, the numbers 0-90 will be considered for group A, the numbers 91-181 for group B and the numbers 182-273 for group C. For concealment, opaque and sealed envelopes will be used. Each number will be written on a card and the cards will be placed inside the envelopes. When a patient enters the study, one of the envelopes is opened and the assigned group of that patient is revealed.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Sequences of the intervention groups will be provided for the operating room in matte envelopes, and When the cesarean section is started, it will be opened by the nurse cooperating in the study. Each group will be treated according to a specific treatment protocol. All participants and surgeons will be unaware of the grouping of the participants before the time of the intervention.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-08-02, 1400/05/11
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Ethics committee reference number
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IR.TBZMED.REC.1400.409
Health conditions studied
1
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Description of health condition studied
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Postpartum hemorrhage
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ICD-10 code
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072.1
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ICD-10 code description
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Other immediate postpartum haemorrhage
Primary outcomes
1
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Description
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Bleeding volume during cesarean section
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Timepoint
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After the placenta is removed until the uterus is repaired
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Method of measurement
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Number of gases and lumps of wet gases and volume of blood in suction
2
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Description
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Bleeding volume during the first 24 hours of cesarean section
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Timepoint
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Hemoglobin and hematocrit are measured 24 hours after surgery and compared with preoperative values.
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Method of measurement
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blood test
3
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Description
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Duration of surgery
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Timepoint
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From the start of surgery to complete repair of the uterus
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Method of measurement
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Record start and end times
Secondary outcomes
1
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Description
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Drug side effects
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Timepoint
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From the time of hospitalization to the patient's discharge
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Method of measurement
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Control vital signs
Intervention groups
1
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Description
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Intervention group 1: Oxytocin 10 units (inside 500 cc of Ringer's serum) and sublingual misoprostol tablets of 400 micrograms (after placental abruption and uterine correction are inserted in the patient's sublingual and controlled by anesthesia technician to prevent suffocation.)
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: Oxytocin recipient 10 units (inside 500 cc of Ringer serum) and intrauterine misoprostol tablet of 400 micrograms (after placental abruption and uterine correction, it is inserted in two uterine poles - 200 micrograms in each cornea)
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Category
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Treatment - Drugs
3
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Description
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Intervention group 3: Oxytocin receptor 30 units (within 500 cc of Ringer serum)
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for Research,Tabriz University Of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available