Prevention of Primary Postpartum Haemorrhage
Primary Purpose
Primary, Post Partum Hemorrhage
Status
Unknown status
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Misoprostol
Oxytocin
Sponsored by
About this trial
This is an interventional prevention trial for Primary focused on measuring primary,oxytocin,, postpartum haemorrhage, mesoprostol
Eligibility Criteria
Inclusion Criteria
- 1. All LSCS including emergency and elective 2. Full term pregnancy >37 week
Exclusion Criteria:
- 1. All vaginal deliveries 2. Patients with bleeding or clotting disorders 3. Maternal cardiac, renal, hepatic diseases 4. Morbidly adherent placentas 5. Preterm deliveries
Sites / Locations
- Islamabad medical and Dental CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
intrauterine misoprostol and oxytocin
oxytocin
Arm Description
there will be added effect of misoprostol to stimulate uterine contraction along with oxytocin
only oxytocin will stimulate uterine contraction
Outcomes
Primary Outcome Measures
measurement of haemoglobin level to assess the blood loss
haemoglobin will be measured preoperatively and postoperatively to minimize the blood loss during cesarean section
Secondary Outcome Measures
Full Information
NCT ID
NCT04724187
First Posted
October 28, 2020
Last Updated
February 24, 2021
Sponsor
Islamabad Medical and Dental College
1. Study Identification
Unique Protocol Identification Number
NCT04724187
Brief Title
Prevention of Primary Postpartum Haemorrhage
Official Title
Comparison of Intrauterine Misoprostol Plus Intravenous Oxytocin Versus Intravenous Oxytocin Alone for Prevention of Primary Postpartum Haemorrhage in Population of Bhara Kahu.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 3, 2021 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Islamabad Medical and Dental College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Postpartum hemorrhage, is one of the most deadly complication of pregnancy worldwide and major cause of maternal mortality especially in third world countries .1 PPH affects about 5% of all women giving birth around the world 2 .Primary PPH is defined as ≥500 mL blood loss after vaginal delivery or ≥1000 mL after CS delivery within 24 hours after birth1 . Globally, almost one quarter of all maternal deaths are linked with PPH 2. Due to the high prevalence of anemia among pregnant women in low-resource settings, the outcome of PPH is often deteriorated, resulting in damaging health consequences 3. Roughly in 70% of cases of primary pph are due to uterine atony11. Uterine atony is due to loss of contraction and retraction of myometrial muscle fibers can lead to severe hemorrhage and shock. There are several reasons behind uterine atony including maternal anemia, fatigue due to prolong labour and rapid forceful labour. Blood loss is double in caesarean section due to use of increased anesthetic agents4. According to WHO use of oxytocin (10 IU, IM /IV) is recommended for prevention of PPH for all births2. Despite its effectiveness, 10-40% of cases need additional uterotonics to ensure good uterine contraction.5 After oxytocin , Misoprostol is increasingly known as a potential treatment option for PPH 5 .Misoprostol is easily available , rapid acting , and cost effective with minimal side effects, however in caesarean section owing to the effect of anesthesia limits its use . In recent study conducted at Egypt, oxytocin plus misoprostol (study group) is compared with oxytocin alone (control group). Incident of pph was significantly lower in study group (p=0.018), as in study group (1.33%) than control group (6.67%)8. Misoprostol is an autacoid substance and act better if placed closed to target organ 9. Several routes of misoprostol, with or without oxytocin, and its result on intrapartum and postpartum hemorrhage are described in the literature. The practice of misoprostol by the intrauterine route during caesarean section is under trial.10. Aim of study is to observe the effectiveness of intrauterine misoprostol in addition to oxytocin to minimize the blood loss during caesarean section.
Detailed Description
Data will be collected from all the patients full filling inclusion criteria on especially designed Performa after informed consent of patient, demographic data will be collected on that preform Patients will be randomized and divide in to two groups group A ( study group ) and group B (controls) , patients under group A will be given 600 microgram misoprostol through intra uterine route during lower segment caesarean section after delivery of placenta in addition to oxytocin 10IU IV and Group B (control) only oxytocin 10IU IV will be given according to WHO protocol .In both groups pre-operative hemoglobin done within 24 hours before the surgery will be recorded and compared with post-operative hemoglobin estimated by blood sample taken 48 hours after the surgery .Mean blood loss during caesarean section will be documented by counting the number of towels , need of additional drugs (repeat oxytocin, tranexamic acid, additional misoprostol) ,time of contractility of uterus, blood transfusion, side effects of misoprostol that is fever, shivering, nausea, vomiting will be recorded 24 hours postoperative period.
All the collected data will be entered and analyzed by SPSS v. 21. Mean and standard deviation will be calculated for quantitative variables like age, gestational age, BMI, pre and post Hb, and blood loss during caesarean section. Frequencies along with percentages will be presented for qualitative variables like need of additional drugs, and side effects of misoprostol (fever, shivering, nausea, vomiting). Paired sample t-test will be used to compare pre and post Hb levels of both groups. Independent sample t-test will be applied to compare post Hb level, blood loss between both groups. Chi-square test will be employed to compare side effects (fever, shivering, nausea, vomiting) between both groups. P-value ≤ 0.05 will be taken as significant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary, Post Partum Hemorrhage
Keywords
primary,oxytocin,, postpartum haemorrhage, mesoprostol
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intrauterine misoprostol and oxytocin
Arm Type
Experimental
Arm Description
there will be added effect of misoprostol to stimulate uterine contraction along with oxytocin
Arm Title
oxytocin
Arm Type
Active Comparator
Arm Description
only oxytocin will stimulate uterine contraction
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Arthotec
Intervention Description
it is prostaglandin E1 .
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
syntocinon
Intervention Description
it stimulates uterine contractions
Primary Outcome Measure Information:
Title
measurement of haemoglobin level to assess the blood loss
Description
haemoglobin will be measured preoperatively and postoperatively to minimize the blood loss during cesarean section
Time Frame
six months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
reproductive age group 18-40years
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
1. All LSCS including emergency and elective 2. Full term pregnancy >37 week
Exclusion Criteria:
1. All vaginal deliveries 2. Patients with bleeding or clotting disorders 3. Maternal cardiac, renal, hepatic diseases 4. Morbidly adherent placentas 5. Preterm deliveries
Facility Information:
Facility Name
Islamabad medical and Dental College
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afnan Rizwan, Fellowship
Phone
+92 3329306328
Email
afnan.rizwan@imdcollege.edu.pk
First Name & Middle Initial & Last Name & Degree
Naila I Hadi, PhD
Phone
+92 3009299512
Email
naila.irum@imdcollege.edu.pk
First Name & Middle Initial & Last Name & Degree
Kinza Alam, Fellowship
12. IPD Sharing Statement
Learn more about this trial
Prevention of Primary Postpartum Haemorrhage
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