Objectives:
The results of investigators’ findings show that Melatonin hormone has a synergic effect with Oxytocin hormone in increasing uterus contractions during delivery and prevention of postpartum atony. The aim of the present study is to assess the effect of Melatonin on prevention of postpartum hemorrhage.
Design:
140 term pregnant women will enter the study. After evaluating primary levels of serum hemoglobin and hematocrit, the patients will be randomly divided into two groups (control or intervention).
Setting and conduct:
The patients in the control group will receive only the standard treatment for uterus bleeding, i.e. Oxytocin intravenous fluid. The patients in the intervention group will receive the same treatment plus 3 doses of Melatonin tablets sublingually.
Major Inclusion and Exclusion criteria:
Term pregnant women with simultaneous labor pain and hemoglobin level above 10 mg/dl without history of underline disease and need for delivery induction, cesarean section or blood transfusion.
Intervention:
Receiving or not receiving Melatonin
Main outcome measures (variables):
Until 24 hours after delivery the patients’ serum hemoglobin and hematocrit levels will be evaluated and compared with the primary levels.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015050919037N9
Registration date:2015-06-01, 1394/03/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-01, 1394/03/11
Registrant information
Name
Mahdieh Yousef-Zanjani
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6004
Email address
yusefi.mahdieh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-12-01, 1393/09/10
Expected recruitment end date
2015-05-31, 1394/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of using and not using of melatonin on prevention of patients' postpartum uterus bleeding after normal vaginal delivery
Public title
Evaluation of the effect of Melatonin on prevention of postpartum bleeding
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Term pregnant women with simultaneous labor pain and hemoglobin level above 10 mg/dl.
Exclusion criteria:
History of underline disease, dystocia, multiparity, chorioamnionitis and need for delivery induction, cesarean section or blood transfusion.
Age
From 18 years old to 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Participants will be divided into two groups (control or intervention) using random number tables.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin university of medical sciences
Street address
Shahid Bahonar Boulevard
City
Qazvin
Postal code
Approval date
2014-06-02, 1393/03/12
Ethics committee reference number
28.20.8835
Health conditions studied
1
Description of health condition studied
Postpartum haemorrhage
ICD-10 code
O72
ICD-10 code description
haemorrhage after delivery of fetus or infant
Primary outcomes
1
Description
Serum hemoglobin level
Timepoint
Until 24 hours after delivery (every 6 hours)
Method of measurement
Blood sampling test
2
Description
Serum hematocrit level
Timepoint
Until 24 hours after delivery (every 6 hours)
Method of measurement
Blood sampling test
Secondary outcomes
1
Description
Blood pressure
Timepoint
Until 6 hours after delivery, every 2 hours
Method of measurement
Monitor device
2
Description
Heart rate
Timepoint
Until 6 hours after delivery, every 2 hours
Method of measurement
Monitor device
Intervention groups
1
Description
Group 1 (control):
Only the usage of needed dosage of Oxytocin intravenous fluid (common and standard treatment) for prevention of postpartum hemorrhage
Category
Prevention
2
Description
Group 2 (intervention):
Receive 3 doses of Melatonin sublingually: 6 mg at 7 cm dilatation, 3 mg after fetus exit and 3 mg 1 hour after delivery. (Tablet Melatonin 3 mg from NatureMade company, The USA)
Plus
Usage of needed dosage of Oxytocin intravenous fluid (common and standard treatment) for prevention of postpartum hemorrhage