(1) Objectives: To determine the efficacy of a special food (fried egg with grape molasses) on threatened abortion. (2) Design: A randomized controlled Phase 2 single-blind clinical trial. (3) Setting and conduct: 90 pregnant women with threatened abortion (n = 45 per group), with mild to moderate severity of vaginal bleeding and gestational age below 12 weeks, coming to Childbirth Emergency or Perinatology clinic of ValiAsr Hospital or Traditional Iranian Medicine clinic of Tehran University of Medical Sciences. They are placed randomly into two groups: control (routine of threatened abortion) and intervention (dietary consumption of egg with grape molasses+ routine management of threatened abortion). (4) Participants: Pregnant women with threatened abortion issue with mild to moderate severity of vaginal bleeding, gestational age below 12 weeks, after confirming the ultrasound and the absence of exclusion criteria (mother systemic illness, history of recurrent miscarriage, Open cervix more than two centimeters, absence of a normal gestational sac at 5 weeks gestational age, a yolk sac or cardiac activity at 7 weeks GA, incomplete abortion, missed abortion or multiple gestation sacs in ultrasound) are enrolled. (5) Interventions: In the control group, intravaginal Cyclogest 200 mg daily, bed rest at home and abstinence from sexual intercourse until vaginal bleeding is stopped; then Cyclogest prescribed every other day until one week. In the intervention group, In addition to routine management, the special food of fried egg with grape molasses will be given to patients. The other conditions of intervention group, including the duration of eating this food, are similar to the control group. (6) Main outcome measures: The primary outcome of this study is determine the miscarriage rate (loss of an intrauterine pregnancy at ≤20 week’s gestation) in patients with threatened abortion. Secondary outcome is the average duration of vaginal bleeding.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040627248N1
Registration date:2016-07-09, 1395/04/19
Registration timing:prospective
Last update:
Update count:1
Registration date
2016-07-09, 1395/04/19
Registrant information
Name
Fatemeh Moradi
Name of organization / entity
School of Traditional Medicine, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6697 6527
Email address
fmoradi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Tehran University of Medical Sciences, University School of Traditional Medicine
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of a special food (fried egg with grape molasses) on threatened abortion: a randomized controlled trial
Public title
Effect of a special food (fried egg with grape molasses) on threatened abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women presenting with mild to moderate vaginal bleeding (using 2 Pads or less per day) ; Up to 12 weeks of pregnancy ; Normal ultrasound (including the normal gestational sac morphology at 5 weeks gestation, or the presence of a yolk sac and foetal cardiac activity at 7 weeks gestation) ; Closed cervix in vaginal examination ; Singleton pregnancy ; Having consent to participate in the study ; Tendency to consume this special food (in intervention group) ; No fried eggs with grape molasses in routine diet food. Exclusion criteria: Mother systemic illness such as fever, diabetes, chronic hypertension, thyroid disorders and etc.; History of recurrent miscarriage; Heavy vaginal bleeding (>2 pads soaked); Loss of conception tissue; Open cervix (>2 centimeters) in vaginal examination; Cervical lesions such as polyps or cervicitis; Abnormal findings on ultrasound (absence of a normal gestational sac at 5 weeks gestational age, a yolk sac or cardiac activity at 7 weeks gestational age, incomplete abortion, missed abortion); Multiple gestation sacs; Molar pregnancy; Fetal or uterine anomalies; Allergy or intolerance to eggs, grape molasses or progesterone; The patient withdrew from the study.
Age
From 12 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
None
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2016-06-12, 1395/03/23
Ethics committee reference number
IR.TUMS.VCR.REC.1395.121
Health conditions studied
1
Description of health condition studied
Threatened abortion
ICD-10 code
O20.0
ICD-10 code description
Haemorrhage specified as due to threatened abortion
Primary outcomes
1
Description
Determine the miscarriage rate (loss of an intrauterine pregnancy at ≤20 week’s gestation) in patients with threatened abortion
Timepoint
Weekly follow-up until vaginal bleeding has been stopped And follow-up at 20 weeks of pregnancy
Method of measurement
Self-designed form
Secondary outcomes
1
Description
The average duration of vaginal bleeding
Timepoint
Weekly follow-up until vaginal bleeding has been stopped And follow-up at 20 weeks of pregnancy
Method of measurement
Self-designed form
Intervention groups
1
Description
Intervention group:
In addition to intravaginal Cyclogest, the food recipe of fried eggs with butter and grape molasses will be given to patients. The other conditions of intervention group, including the duration of eating this food, are similar to the control group.
Category
Treatment - Other
2
Description
Control group:
Cyclogest (intravaginal progesterone) 200 mg daily, bed rest at home and abstinence from sexual intercourse until vaginal bleeding is stopped; then cyclogest prescribed every other day until one week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Childbirth Emergency of Vali-e-Asr Hospital, Tehran University of Medical Sciences (TUMS)
Full name of responsible person
Dr Fatemeh Moradi
Street address
Imam Khomeini Hospital Complex, End of Keshavarz Blv,
City
Tehran
2
Recruitment center
Name of recruitment center
Perinatology clinic of Vali-e-Asr Hospital, Tehran University of Medical Sciences (TUMS)
Full name of responsible person
Dr Fatemeh Moradi
Street address
Imam Khomeini Hospital Complex, End of Keshavarz Blv,
City
Tehran
3
Recruitment center
Name of recruitment center
Traditional Iranian Medicine clinic, Tehran University of Medical Sciences (TUMS)
Full name of responsible person
Dr Fatemeh Moradi
Street address
School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
3. Vice Chancellor for research, School of Traditional medicine, Tehran University of Medical Scienc
Full name of responsible person
Dr Roja Rahimi
Street address
School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
3. Vice Chancellor for research, School of Traditional medicine, Tehran University of Medical Scienc
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 Traditional Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Fatemeh Moradi
Position
PhD candidate of Traditional Medicine
Other areas of specialty/work
Street address
School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
City
Tehran
Postal code
1449614353
Phone
+98 21 6697 6527
Fax
+98 21 6697 6527
Email
dfmoradi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Traditional medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Malieheh Tabarraie Arani
Position
PhD of Traditional Medicine
Other areas of specialty/work
Street address
School of Traditional medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
City
Tehran
Postal code
1449614353
Phone
+98 21 6697 6527
Fax
+98 21 6697 6527
Email
dr.mtabarrai@yahoo.com
Web page address
http://tim.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Dr Fatemeh Moradi
Full name of responsible person
Dr Fatemeh Moradi
Position
School of Traditional Medicine, Tehran University of Medical Sciences
Other areas of specialty/work
Street address
PhD candidate of Traditional Medicine
City
Tehran
Postal code
1449614353
Phone
+98 21 6697 6527
Fax
+98 21 6697 6527
Email
dfmoradi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)