Comparison of rectal and subcutaneous administration of misoprostol in bleeding during and after cesarean section
Design
Randomized clinical trial on two intervention groups of rectal misoprostol and sublingual misoprostol
Settings and conduct
This randomized double-blind clinical trial study will be performed on 80 pregnant women who referred to Shahid Sadoughi Hospital in Yazd for elective cesarean section. Mothers will be randomly divided into two groups. Immediately after the birth of the infant, 20 units of oxytocin will be infused in 500 ml ringer serum in both groups. In the first group 400 μg rectal misoprostol will be administered after spinal anesthesia and in the second group 400 μg sublingual misoprostol.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Pregnant women (gestational age 37 and older), singleton pregnancy, and those who are candidates ofcesarean section
Exclusion criteria:Fetal Distress, Macrosomia, Sensitivity to misoprostol, Previa, and Polyhydramnios
Intervention groups
This study included two intervention groups. The intervention group one consisted of 40 single-term pregnant women (gestational age 37 weeks and older) who were candidates for cesarean section and received rectal misoprostol.The intervention group two consisted of 40 pregnant women with similar conditions and received sublingual misoprostol.Both intervention groups received placebo during the intervention.
Main outcome variables
count of bleeding during and after delivery of cesarean section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190204042614N1
Registration date:2020-03-01, 1398/12/11
Registration timing:retrospective
Last update:2020-03-01, 1398/12/11
Update count:0
Registration date
2020-03-01, 1398/12/11
Registrant information
Name
Nooshin Hatamizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
n.hatamizade@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-12-31, 1397/10/10
Actual recruitment start date
2018-05-01, 1397/02/11
Actual recruitment end date
2019-01-21, 1397/11/01
Trial completion date
2019-01-21, 1397/11/01
Scientific title
A comparison of rectal and sublingual Misoprostol on decreas Post -Partum haemorrhage during cesarean section
Public title
A comparison of rectal and sublingual Misoprostol on Post -Partum haemorrhage during cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women who were candidates of Cesarean section
Exclusion criteria:
pregnancy induced hypertension
twin pregnancy
sensitivity to prostaglandin
fetal distress
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
using convenient sampling method, the patients were selected. then, the patients were randomly assigned to two groups of rectal and sublingual using random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher and student
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences Yazd
Street address
Professor Hesabi Blvd, Shohadaye Gomnam Blvd, Medical Sciences Pardis
City
Yazd
Province
Yazd
Postal code
8915173149
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.SSU.MEDICINE.REC.1396.271
Health conditions studied
1
Description of health condition studied
bleeding during and after cesarean section
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hemoglobin before and after surgery
Timepoint
6 hours after surgery
Method of measurement
Cell counter machine
2
Description
Hematocrit before and after surgery
Timepoint
6 hours after surgery
Method of measurement
Cell counter machine
Secondary outcomes
1
Description
Blood pressure
Timepoint
Every 5 minutes during surgery, every 15 minutes in recovery
Method of measurement
Device monitoring
2
Description
Heart beat
Timepoint
Every 5 minutes during surgery, every 15 minutes in recovery
Method of measurement
Device monitoring
Intervention groups
1
Description
Intervention group: Rectal misoprostol is prescribed at a dose of 400 μg after spinal anesthesia. Placebo is also prescribed with rectal misoprostol.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group: sublingual misoprostol is prescribed at a dose of 400 μg after spinal anesthesia. Placebo is also prescribed with rectal misoprostol.