Comparing the efficacy of 17a hydroxyprogesterone caproate ( proluton) versus vaginal progesterone (cyclogest) on perinatal outcome in high risk patients who undergo cerclage
The aim of study was to o compare the effectiveness of 17 alpha hydroxyprogesterone caproat with vaginal progesterone on perinatal outcome.
Design
A randomized, clinical trial with a parallel group design of 58 participants was conducted. Simple randomisation was applied using table of random numbers. Accordingly participants were divided in group A or B.
Settings and conduct
Eligible women referring to Khalij-e-Fars hospital undergo cerclage were allocated to study using table of random number after signing the consent form. Each participants received intervention based on their group. Intervention continued till 36 weeks of pregnancy. Then each participants was followed up by phone contact till 28 days after their delivery. Data were collected and analyzed.
Participants/Inclusion and exclusion criteria
Participants were pregnant women with singleton pregnancy at age of 16-22 weeks of pregnancy with the history of more than 2 previous preterm birth.
Intervention groups
Group A received an intra mascular 250 mg of 17 alpha hydroxyprogesterone caproat (proluton from Bayer company) weekly and group B received 200 mg of vaginal progesterone supp (cyclogest from Actavis company) right after cercelage till 36 weeks of pregnancy.
Main outcome variables
The main outcome of study was the incidence of preterm labor. The second outcomes were as follow: Mode of birth, gestational age at the time of delivery, weight of newborn, apgar of newborn, incidence of newborn respiratory distress syndrome and sepsis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181107041585N4
Registration date:2020-07-10, 1399/04/20
Registration timing:retrospective
Last update:2020-07-10, 1399/04/20
Update count:0
Registration date
2020-07-10, 1399/04/20
Registrant information
Name
Fatemeh Darsareh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3355 4515
Email address
famadarsareh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
2017-05-10, 1396/02/20
Actual recruitment end date
2018-02-25, 1396/12/06
Trial completion date
2018-08-23, 1397/06/01
Scientific title
Comparing the efficacy of 17a hydroxyprogesterone caproate ( proluton) versus vaginal progesterone (cyclogest) on perinatal outcome in high risk patients who undergo cerclage
Public title
Effect of proluton and cyclogest on perinatal outcome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
History of more than two previous preterm birth less than 34 weeks
Singleton pregnancy
Cervical length less than 25 mm based on latest vaginal sonography
Exclusion criteria:
Fetal anomaly
Uterine cramp at the time of study
Vaginal bleeding at the time of study
Preterm rupture of membrane
Allergy to hormonal therapy
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
58
Actual sample size reached:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using a table of random numbers
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 committee of Hormozgan University of Medical Sciences
Street address
Shafa alley, Hormozgan University of Medical Sciences
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Approval date
2018-03-25, 1397/01/05
Ethics committee reference number
IR.HUMS.REC.1397.052
Health conditions studied
1
Description of health condition studied
Preterm birth
ICD-10 code
060
ICD-10 code description
Onset (spontaneous) of labour before 37 completed weeks of gestation
Primary outcomes
1
Description
Incidence of preterm birth
Timepoint
After 34 weeks of pregnancy
Method of measurement
Observational
Secondary outcomes
1
Description
Gestational age at the time of delivery
Timepoint
At the time of delivery
Method of measurement
Clinical patient record
2
Description
Mode of delivery
Timepoint
At the time of delivery
Method of measurement
Clinical patient record
3
Description
Newborn weight
Timepoint
Immediately after delivery
Method of measurement
Clinical patient record
4
Description
Newborn apgar
Timepoint
Immediately after delivery
Method of measurement
Newborn clinical record
5
Description
incidence of newborn respiratory distress syndrome
Timepoint
At birth and 28 days after birth
Method of measurement
Newborn clinical record
6
Description
Incidence of newborn sepsis
Timepoint
At birth and 28 days after birth
Method of measurement
Newborn clinical record
Intervention groups
1
Description
Intervention group: 250 of 17 alpha hydroxyprogesterone caproat weekly immediately after cercelag procedure till 36 weeks of pregnancy
Category
Treatment - Drugs
2
Description
Intervention group: 400 mg of vaginal progestron daily immediately after cercelag procedure till 36 weeks of pregnancy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalij-e-fars hospital
Full name of responsible person
Amene Ranjbar
Street address
Khalij-e-fars hospital, Pardis Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7918796758
Phone
+98 76 3367 0285
Email
ranjbar662@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hormozgan University of Medical Sciences
Full name of responsible person
Teamur Aghamolei
Street address
Shafa alley, Hormozgan University of Medical Sciences
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 1335 0675
Email
t.aghamolaei@yahoo.com
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, Hormozgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Amene Ranjbar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pardis Blvd, Khalij-e-fars hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
7918796758
Phone
+98 76 3367 0285
Email
ranjbar662@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Amene Ranjbar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Khalij-e-fars hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
7918796758
Phone
+98 76 3367 0285
Email
ranjbar662@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Fatemeh Darsareh
Position
Midwife
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Bagh Aonir st. Amir Abad
City
Bandar Abbas
Province
Hormozgan
Postal code
7918796758
Phone
+98 76 3355 4515
Email
famadarsareh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available