The aim of this study is to assess the effect of hydro alcoholic extract of Capsella Bursa Pastoris on postpartum hemorrhage done on 100 women in Afzalipour hospital Kerman. This study is a phase 2 clinical trial. The intervention group received ten sublingual drops of hydro alcoholic extract of Capsella Bursa Pastoris( equivalent 10 grams of plant ) plus routine treatment (Infusion of 20 units of oxytocin in 1 litter of Ringer) and the control group received ten sublingual drops of the placebo (saline 9.0%) plus routine treatment (Infusion of 20 units of oxytocin in 1 litter of Ringer) after placental expulsion and the subjects were asked to hold drops under the tongue for a minute. Then, all samples were assessed until 3 hour after delivery for estimation of postpartum hemorrhage and pulse rate and blood pressure.6 hours after delivery hemoglobin and hematocrit were checked for estimation of postpartum hemorrhage.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072529066N1
Registration date:2016-09-04, 1395/06/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-04, 1395/06/14
Registrant information
Name
Sahar Ghalandari
Name of organization / entity
School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3322 7641
Email address
sahar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of the hydro alcoholic extract of capsella bursa pastoris on postpartum hemorrhage
Public title
Effect of Capsella Bursa Pastoris on postpartum hemorrhage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The age between 20 and 35 years; the number of pregnancies less than 3; Gestational ages between 37 to 42 weeks; singleton birth with cephalic presentation; child weigh between 2500 to 4000 grams; the lack of systemic diseases (diabetes, hypothyroidism, coagulation disorders ); lack of cesarean section or uterine surgery or postpartum hemorrhage; lack of complications of pregnancy (poly hydramynus, bleeding and hypertension in pregnancy); do not use the magnesium sulfate during pregnancy; amniotic fluid is clear on during the first stage of labor; no large episiotomy during the second stage of labor (rupture of grade 3 or 4); normal during the first phase (Nulipar: 4.6 hours and up to11.7 hours, multipar: 2.4 hours and up to 5.2 hours), second (nullipar: 50 minutes and multipar: 20 minutes) and third delivery (both 30 minutes); no anemia in the mother.
Exclusion criteria: Caesarean section delivery; not interested to continue to participate in the study; causing any sensitivity to the plant capsella bursa pastoris.
Age
From 20 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Using Exel sofware, women were randomally allocated to Capsella Bursa Pastoris or control.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Velenjak St, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Postal code
1985717443
Approval date
2015-07-13, 1394/04/22
Ethics committee reference number
SBMU2.REC.1394. 16
Health conditions studied
1
Description of health condition studied
Postpartum haemorrhage
ICD-10 code
O72.1
ICD-10 code description
Postpartum haemorrhage
Primary outcomes
1
Description
a mount of bleeding
Timepoint
One hour, two hours, three hours after delivery
Method of measurement
Weighing pad and drape
2
Description
Blood presure
Timepoint
15 minutes, 30 minutes, 45 minutes, one hour, two hours, three hours after delivery
Method of measurement
by sphygnomanometer
3
Description
Hemoglobin and hematocrit level
Timepoint
on admission and 6 hours after delivery
Method of measurement
Hemoglobin and hematocrit assessment
4
Description
Pulse
Timepoint
15 minutes, 30 minutes, 45 minutes, one hour, two hours, three hours after delivery
Method of measurement
by counting
Secondary outcomes
1
Description
Adverse effects
Timepoint
During Hospitalization
Method of measurement
Observation of adverse effects
2
Description
Satisfaction of Treatment
Timepoint
During Hospitalization
Method of measurement
The questions of participants
Intervention groups
1
Description
Intervention group 1: Ten sublingual drops of hydro alcoholic extract of Capsella Bursa Pastoris( equivalent 10 grams of plant )
Category
Treatment - Drugs
2
Description
Control group:ten sublingual drops of the placebo (saline 0.9 %)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Sahar Ghalandari
Street address
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mrs Mahrokh Dolatian
Street address
Shahid Beheshti University of Medical Sciences, Velenjak St, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery of Shahid Beheshti
Full name of responsible person
Sahar Ghalandari
Position
Master of Science University Student of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Valiasr Ave, Niayesh Highway, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
sghalandari68@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nourossadat Kariman
Position
Assistant Professor, PhD of Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Valiasr Ave, Niayesh Highway, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
n_kariman@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar Ghalandari
Position
Master of Science University Student of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Valiasr Ave, Niayesh Highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 23871
Fax
-
Email
sghalandari68@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)