Uterotonics Using to Reduce Bleeding at Cesarean Section
Primary Purpose
Postpartum Haemorrhage
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Misoprostol
Oxytocin
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Haemorrhage
Eligibility Criteria
Inclusion Criteria:
- Gestational age 37-40 wk.
- Elective lower segment cesarean section.
- Under spinal anesthesia.
Exclusion Criteria:
- Anemia (Hb> 8 g%).
- Multiple gestation.
- Antepartum hemorrhage.
- Poly-hydramnios.
- Two or more previous cesarean sections.
- History of previous rupture uterus.
- Current or previous history of significant disease including heart disease, liver, renal disorders or known coagulopathy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sublingual misoprostol
oxytocin
Arm Description
The patients in this arm received 400 micrograms of sublingual misoprostol, immediately after delivery of the neonate.
The patients in this arm received 20 IU oxytocin dissolved in 1 L of Lactated Ringer's or glucose solution) at the rate of 125 ml /h , immediately after delivery of the neonate.
Outcomes
Primary Outcome Measures
Blood loss in ML
Secondary Outcome Measures
Hematocrit value (%)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02562300
Brief Title
Uterotonics Using to Reduce Bleeding at Cesarean Section
Official Title
Comparative Study of Sublingual Misoprostol Versus Oxytocin in Reducing Bleeding at Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Postpartum haemorrhage continues to be a leading cause of maternal morbidity and mortality worldwide and that is according to the estimates of the World Health Organization in 1998. Average blood loss during delivery progressively increases with the type of delivery, vaginal delivery (500 ml), cesarean section (1000 ml) and emergency hysterectomy (3500 ml) of blood.
A reduction of operative blood loss at cesarean section has a great benefit to the patients in terms of decreased postoperative morbidity and a decrease in risks associated with blood transfusions. The routine use of oxytocin is associated with a significant reduction in the occurrence of postpartum hemorrhage.
Excessive blood loss as estimated by a 10% drop in the hematocrit value postdelivery or by need for blood transfusion, occurs in approximately 4% of vaginal deliveries and 6% of cesarean births.
Although many delivery units use oxytocin as the first line agent to prevent uterine atony at cesarean section, it may not be the ideal agent for prevention of postpartum haemorrhage especially in compromised patients with preeclampsia, cardiac disease or prolonged labor. Oxytocin and specifically its preservative chlorobutanol increases the heart rate and has negative inotropic, antiplatelet and antidiuretic effects.
Misoprostol, a prostaglandin E1 analogue, has been shown in many studies to be an effective myometrial stimulant of the pregnant uterus which binds to prostanoid receptors.
Misoprostol administration, either by oral or rectal route, has been shown to be effective in prevention of postpartum haemorrhage and is considered as an effective alternative to other conventional oxytocics especially in developing countries as it is cheap and thermostable.
Pharmacokinetic studies suggested that the bioavailability of misoprostol after sublingual administration was higher than those after oral or vaginal administration.
A few studies are now available for the use of sublingual misoprostol in the prevention of postpartum haemorrhage following vaginal delivery and have reported it as an effective and convenient route of administration.
However, none of the studies conducted so far have evaluated the response of sublingual misoprostol for prevention of postpartum haemorrhage during cesarean section.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Haemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sublingual misoprostol
Arm Type
Active Comparator
Arm Description
The patients in this arm received 400 micrograms of sublingual misoprostol, immediately after delivery of the neonate.
Arm Title
oxytocin
Arm Type
Active Comparator
Arm Description
The patients in this arm received 20 IU oxytocin dissolved in 1 L of Lactated Ringer's or glucose solution) at the rate of 125 ml /h , immediately after delivery of the neonate.
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
400 micrograms of sublingual misoprostol were given immediately after delivery of the neonate.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
20 IU oxytocin dissolved in 1 L of Lactated Ringer's or glucose solution) at the rate of 125 ml /h were given immediately after delivery of the neonate.
Primary Outcome Measure Information:
Title
Blood loss in ML
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Hematocrit value (%)
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age 37-40 wk.
Elective lower segment cesarean section.
Under spinal anesthesia.
Exclusion Criteria:
Anemia (Hb> 8 g%).
Multiple gestation.
Antepartum hemorrhage.
Poly-hydramnios.
Two or more previous cesarean sections.
History of previous rupture uterus.
Current or previous history of significant disease including heart disease, liver, renal disorders or known coagulopathy.
12. IPD Sharing Statement
Learn more about this trial
Uterotonics Using to Reduce Bleeding at Cesarean Section
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