The purpose of this study is to evaluate the effectiveness of sesame as an adjunct (auxiliary) drug in disposal of pregnancy remains. It is a randomized clinical trial without placebo control. The method is that 90 pregnant women 18-50 years old with gestational age below 20 weeks, with the symptoms of incomplete abortion admitted to Women's Hospital Moheb Yas affliated to Tehran University of Medical Sciences. After definitive diagnosis of uncomplicated incomplete abortion, by obstetricians, and after providing the necessary clarifications and considering the inclusion criteria, and filling out the questionnaire consciously, we divided the participants randomly into two groups: 45 patients only received misoprostol and 45 patients received misoprostol with sesame. In addition to misoprostol we give sesame and its preparation and consumption instructions to second group of patient (according to protocol). All patients completed follow-up clinical symptoms questionnaire at home and at the end of the second week they come for sonography. The primary outcome in this study was to determine the amount of pregnancy debris at the end of the second week, and secondary outcome examined the incidence and severity of clinical symptoms related to incomplete abortion ( abdominal or pelvic pain and cramp and bleeding) and should take painkillers and antibiotics and blood transfusions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122729062N1
Registration date:2016-12-27, 1395/10/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-27, 1395/10/07
Registrant information
Name
Zahra Aghababaei
Name of organization / entity
Isfahan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 8108
Email address
zahra.aghababaei@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analyze the effect of the sesamum indicum on The termination of an incomplete abortion
Public title
Analyze the effect of the sesamum indicum on disposal of the pregnancy remains.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteri:
1 - Pregnant women 18_50 years pld admitted to Moheb Yas women hospital of Tehran, less than 20 weeks gestational age and with clinical or ultrasound evidence of incomplete abortion.
2 - Lack of infectious abortion’s signs (a) 38 degrees fever or more (b) INDEX (c) 3 degrees fever per hour or more in the first 24 hours.
3 - Lack of any signs of Induced abortion and manipulation by the patient.
4 - Lack of repeated abortion (RPL) due to anatomical disease of mother (Septate Uterus, Unicorns uterus, short Cervix) and diagnosed chromosomal disorders of parents leading to fetal death or blighted ovum and fetal abnormalities including Malformation and Dysmorphic Show, Monosomy X.
5 -The risk of any base disease (Diabetes - blood pressure - kidney failure - heart and liver illness).
6 - Lack of signs of hemorrhagic shock Grade 1(Bleeding more than 750 cc).
7 - Lack of ectopic pregnancy.
8 - Lack of open cervical in examination.
Exclusion criteria:
1 - The emergence of allergies to sesame or its components.
2 - Severe abdominal pain that require emergency intervention.
3 - Fever over 38 degrees.
4 - Sepsis that require antibiotic treatment or abortion.
5 - Severe bleeding (bleeding more than 750 CC).
6 - Unwillingness to continue cooperation.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib
City
Isfahan
Postal code
Approval date
2016-08-07, 1395/05/17
Ethics committee reference number
IR.MUI.REC.1395.3.616
Health conditions studied
1
Description of health condition studied
The remains of a pregnancy
ICD-10 code
O03.4
ICD-10 code description
Spontaneous abortion : incomplete, without complication
Primary outcomes
1
Description
The full disposal of the products of pregnancy
Timepoint
Two weeks after intervention
Method of measurement
Sonography
Secondary outcomes
1
Description
Amount of bleeding
Timepoint
During the intervention
Method of measurement
PBAC questionnaire
2
Description
The time of bleeding stop
Timepoint
Daily medication and the end of the second week
Method of measurement
PBAC questionnaire
3
Description
Amount and intensity of pain
Timepoint
Daily medication and the end of the second week
Method of measurement
VAS questionnaire
4
Description
Amount of painkiller
Timepoint
Daily medication and the end of the second week
Method of measurement
Researcher questionnaire
5
Description
The incidence of misoprostol’s effects
Timepoint
Daily medication and the end of the second week
Method of measurement
Researcher questionnaire
Intervention groups
1
Description
We delivered 10 packs 60 grams of sesame to the intervention group and also we trained them How to prepare and use it. For 5 days, twice a day, in the same time misoprostol tablets prescribed by obstetrician.
Category
Treatment - Drugs
2
Description
They prescribed misoprostol tablets routinely to the control group by obstetricians.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Moheb Yas Women’s General Hospital
Full name of responsible person
Zahra Aghababaie
Street address
Moheb Yas Women’s General Hospital, North Nejatollahi ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chacellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Mohammad Mazaheri
Street address
Traditional Medicine Department, Isfahan University of Medical Sciencesedical Science.
City
Isfahan
Grant name
Grant code / Reference number
395616
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chacellor for research, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Zahra Aghababaei
Position
PhD student of Traditional Medicine
Other areas of specialty/work
Street address
Ahmadiye clinic, Tabriz alley, north Sarparast street, Taleghani street
City
Tehran
Postal code
Phone
+98 21 8897 6527
Fax
Email
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Nejat Bakhsh
Position
PhD Assistance professor of Traditional Medicine
Other areas of specialty/work
Street address
Amadiye clinic, Tabriz alley, North Sarparast, Taleghani street
City
Tehran
Postal code
Phone
+98 21 8897 6527
Fax
Email
nejatbakhsh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Zahra Aghababaei
Position
PhD student of Traditional Medicine
Other areas of specialty/work
Street address
Ahmadiye clinic, Tabriz alley, north Sarparast street, Taleghani street
City
Tehran
Postal code
Phone
+98 21 8897 6527
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)