Protocol summary

Summary
Objectives: Spontaneous abortion is the most common pregnancy complications that can had a bad psychological effect on the lives of couples seeking to have a baby. In the early stages Continuation of pregnancy, depends on progesterone production by the corpus luteum. Impaired glucose metabolism during pregnancy is the most important diseases in pregnancy, using oral progesterone to prevent preterm delivery in pregnant women are widely prescribed by gynecologists. We decided to study the effect of oral progesterone (dydrogestron) on incidence of glucose intolerance in pregnant females with threatened abortion. Design & setting & conduct: In this prospective study 50 pregnant women who were tested for blood sugar and had normal blood sugar levels with gestational age less than 14 weeks and complaint threatened abortion, had administration of oral Dydrogesterone 10 mg twice daily to prevent miscarriage and preterm delivery. 50 women who did not use oral dydrogesterone formed the control group. Inclusion criteria: singleton pregnancy, the absence of any systemic disease, age less than 30 years, BMI less than 25, no history of stillbirth, having a family history of diabetes Exclusion criteria: smoking, history of diabetes, gestational diabetes and other systemic diseases, any fetal abnormalities on ultrasound, multiple pregnancy, and previous macrosomia. Interventions: oral administration of dydrogesterone 10 mg twice daily. Outcome: GTT and GCT was checked in14 weeks of gestational age Pregnancy.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015020217035N2
Registration date: 2016-07-19, 1395/04/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-19, 1395/04/29
Registrant information
Name
Maryam Kasraeian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 32365
Email address
kasraeem@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral progesterone(dydrogestron) on incidence of glucose intolerance in pregnant females with threatened abortion
Public title
Effect of oral progesterone(dydrogestron) on incidence of glucose intolerance in pregnant females with threatened abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: singleton pregnancy, the absence of any systemic disease, age less than 30 years, BMI less than 25, no history of stillbirth, having a family history of diabetes Exclusion criteria: smoking, history of diabetes, gestational diabetes and other systemic diseases, any fetal abnormalities on ultrasound, multiple pregnancy, previous macrosomia
Age
From 14 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Cmmittee of Shiraz University of Medical Sciences
Street address
Zand Avenue
City
Shiraz
Postal code
Approval date
2015-06-10, 1394/03/20
Ethics committee reference number
IR.SUMS.med.REC.1394.25

Health conditions studied

1

Description of health condition studied
Gestational Diabetes
ICD-10 code
Z35
ICD-10 code description
high-risk pregnancy

Primary outcomes

1

Description
FBS
Timepoint
At Gestational age 14 weeks
Method of measurement
Gelocometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: to prevent miscarriage and preterm delivery, had administration of oral Dydrogesterone 10 mg twice daily for intervention group
Category
Treatment - Drugs

2

Description
Control group:the 50 women who did not use oral dydrogesterone formed the control group.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Dr Behnaz Karami
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor Of Research, Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Zand Avenue
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Research, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Behnaz Karami
Position
Student
Other areas of specialty/work
Street address
Zand Avenue
City
Shiraz
Postal code
Phone
+98 71 3612 8257
Fax
Email
drkaramigyneco@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Maryam Kasraeian
Position
Assistant professor
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
Phone
+98 71361222220
Fax
Email
maryamkasraeian@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Maternal Fetal Medicine Research Center
Full name of responsible person
Khadije Bazrafshan
Position
Master
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
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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