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Effect of concomitant administration of vaginal progesterone and vitamin D3 in the treatment of unexplained recurrent abortion in pregnant women

Protocol summary

Summary
The purpose of this double-blinded clinical trial is to determine the effect of concomitant administration of vaginal progesterone and vitamin D3 in the treatment of unexplained recurrent abortion in pregnant women referring to Shabih Khani Hospital in Kashan. In this study, all women with history of recurrent abortions of unknown causes are entered into the study after obtaining informed consent. After performing a complete history and physical exam, the patients' demographic data and obstetric history are obtained using a questionnaire. After performing complete lab tests including Anticardiolipin, TSH, PT, PTT, INR, B2GP, factor v leiden, protein s and c, prolactin, and Lupus anticoagulants; the parents' karyotype to rule out chromosomal disorders; Hysterosalpingography to rule out uterine anomalies and applying the inclusion and exclusion criteria; 80 patients are selected and divided into two groups of 40 with block sizes of 4 and 6. In the first group vaginal progesterone is administered alone at a dose of 400 mg daily and the second group is treated with the same dose of vaginal progesterone and vitamin D pearls at a dose of 4000 IU daily. Both groups will also receive standard supplements such as iron and folic acid. All patients will be followed until the 20th week of pregnancy. At the end of the 20th week, occurrence or non-occurrence of abortion and the levels of inflammatory factors such as IL17 will be evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013100114853N1
Registration date: 2013-10-30, 1392/08/08
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-10-30, 1392/08/08
Registrant information
Name
Farzaneh Amini
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
amini-si@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of concomitant administration of vaginal progesterone and vitamin D3 in the treatment of unexplained recurrent abortion in pregnant women
Public title
The impact of vaginal progesterone and vitamin D3 on the treatment of unexplained recurrent abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Incidence of 3 or more consecutive recurrent abortions or 2 or more non consecutive abortions; Age less than 35 years and above 18 years; The absence of any known causes of abortion; Pregnancies from one single husband in previous and current abortions Exclusion criteria: Uterine anomalies; The history of allergy on the consumption of progesterone and multivitamins containing vitamin D3; initial abnormal tests of thyroid abnormalities, prolactin, antiphospholipid antibody syndrome and thrombophilia
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences ethics committee
Street address
Pezeshk Blvd., Ghotb Ravandi Blvd., Kashan Medical Sciences complex, Vice chancellor for research
City
Kashan
Postal code
88141/87159
Approval date
2013-08-26, 1392/06/04
Ethics committee reference number
P/29/5/1/2059

Health conditions studied

1

Description of health condition studied
Recurrent abortion
ICD-10 code
O03
ICD-10 code description
spontaneous abortion

Primary outcomes

1

Description
continuation of pregnancy beyond 20 weeks of pregnancy in women with recurrent abortion
Timepoint
20 weeks after the first day of last menstural period
Method of measurement
clinical, laboratory and sonographic findings

Secondary outcomes

1

Description
continuation of pregnancy
Timepoint
after pregnancy termination
Method of measurement
after pregnancy termination

Intervention groups

1

Description
control group: Participants are treated with 400 mg vaginal progesterone suppositories (manufactured by Behvazan Pharmaceutical company, Iran) at a dose of 400 mg/day until the 20th week of pregnancy.
Category
Treatment - Drugs

2

Description
control group: Participants are treated with vaginal progesterone suppositories at a dose of 400 mg/day manufactured by Behvazan Pharmaceutical company, Iran, and vitamin D3 at a dose of 4000 IU/day (slow-release tablets of vitamin D manufactured by Dana Pharmaceutical company).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shabih Khani Hospital of Kashan
Full name of responsible person
Farzaneh Amini
Street address
Shabih Khani Maternity Hospital, Shahid Beheshti Street, Ayatollah Kashani Crossroad
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Vice Chancellor for research, Kashan University of Medical Sciences complex, Pezeshk Blvd., Ghotbe Ravandi Blvd.
City
Kashan
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, Kashan 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
Department of Obstetrics and Gynecology, Kashan Medical School
Full name of responsible person
Farzaneh Amini
Position
Resident of ob & gyn/ MD
Other areas of specialty/work
Street address
Shabih Khani Maternity Hospital, Shahid Beheshti Street, Ayatollah Kashani Crossroad
City
Kashan
Postal code
8714715555
Phone
+98 36 1446 0180
Fax
Email
amini-si@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Farzaneh Amini
Position
Resident of ob & gyn/ MD
Other areas of specialty/work
Street address
Shabih Khani Maternity Hospital, Shahid Beheshti Street, Ayatollah Kashani Crossroad
City
Kashan
Postal code
8714715555
Phone
+98 36 1446 0180
Fax
Email
amini-si@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Obstetrics and Gynecology, Kashan Medical School
Full name of responsible person
Farzaneh Amini
Position
Resident of ob & gyn/ MD
Other areas of specialty/work
Street address
Shabih Khani Maternity Hospital, Shahid Beheshti Street, Ayatollah Kashani Crossroad
City
Kashan
Postal code
Phone
+98 36 1446 0180
Fax
Email
amini-si@kaums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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