To compare the effectiveness of oral versus vaginal progestogens in treating recurrent miscarriages.
Design
108 participants, parallel-group, no blindness, randomized control trial, phase 4
Settings and conduct
study was performed at Post Graduate Medical Institute (PGMI), Lady Reading Hospital Peshawar,
Participants/Inclusion and exclusion criteria
Inclusion criteria: pregnant women; aged 16-40 years, with a history of at least three recurrent miscarriages; visiting at or less than 7 weeks of gestation.
Exclusion criteria: patients with threatened miscarriage, structural uterine abnormality distorting the cavity, the absence of fetus cardiac activity (missed abortion), contraindications to progestogens use (e.g. allergy to progesterone, patient with breast carcinoma)' inadequate treatment compliance.
Intervention groups
Oral progestogen was given to group A in the dose of 10mg twice a day for 12 weeks in the morning and evening after meals, while group B received vaginal progestogens in the dose of 200mg twice a day for 12 weeks.
Main outcome variables
Miscarriage
General information
Reason for update
Acronym
Progestogens for recurrent miscarriages trial
IRCT registration information
IRCT registration number:IRCT20230117057148N1
Registration date:2023-04-06, 1402/01/17
Registration timing:retrospective
Last update:2023-04-06, 1402/01/17
Update count:0
Registration date
2023-04-06, 1402/01/17
Registrant information
Name
Rizwan Faisal
Name of organization / entity
Rehman Medical Institute
Country
Pakistan
Phone
+92 333 9120587
Email address
drrizwanfaisal@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-02, 1399/01/14
Expected recruitment end date
2020-09-15, 1399/06/25
Actual recruitment start date
2020-04-02, 1399/01/14
Actual recruitment end date
2020-09-15, 1399/06/25
Trial completion date
2020-09-15, 1399/06/25
Scientific title
Efficacy of oral versus vaginal progestogens in the maintenance of early pregnancy in women with recurrent miscarriages
Public title
Oral versus vaginal progestogens in women with recurrent miscarriages
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnancy
Aged 16-40 years,
A history of at least three recurrent miscarriages
At or less than 7 weeks of gestational age
Exclusion criteria:
Threatened miscarriage,
Breast carcinoma
Structural uterine abnormality distorting the cavity,
Absence of fetal cardiac activity (missed abortion),
Contraindications to progestron use (e.g. allergy to progesterone)
Inadequate treatment compliance
Age
From 16 years old to 40 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
108
Actual sample size reached:
108
Randomization (investigator's opinion)
Randomized
Randomization description
All the included patients were given code from 1-108, these codes were entered in the computer , through SPSS random numbers were generated. Computer itself divided numbers randomly in to 2 groups i.e 54 in one and 54 in other group.
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 the college of physicians and surgeons Pakistan
Street address
House No. T-825, Street No. 5, Opposite
City
Peshawar
Postal code
25000
Approval date
2020-03-01, 1398/12/11
Ethics committee reference number
CPSP/REU/OBG-2014-022-6174
Health conditions studied
1
Description of health condition studied
recurrent miscarriages
ICD-10 code
O03
ICD-10 code description
Spontaneous abortion
Primary outcomes
1
Description
Pregnancy
Timepoint
12 weeks of gestation
Method of measurement
ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Interventional Group 1: This group will be given oral progestogens in a dose of 10mg twice a day in morning and evening after meals for 12 weeks. Efficacy will be measured by continuation of pregnancy beyond 12 weeks. All the data will be recorded in predesigned data. Transvaginal ultrasound will be performed at 7, 9 and 12 week of gestation. Ultrasonography will be looked for presence of fetal cardiac activity. This group will also serve as control as it is the standard routine route by which progestogens are given.
Category
Treatment - Other
2
Description
Intervention group 2: This group was prescribed vaginal progestogens in a dose of 200mg twice a day for 12 weeks. Efficacy was measured by continuation of pregnancy beyond 12 weeks. All the data will be recorded in predesigned data. Transvaginal ultrasound will performed at 7, 9 and 12 week of gestation. Ultrasonography will be looked for presence of fetal cardiac activity
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Lady Reading Hospital Peshawar
Full name of responsible person
Dr.Laiyla Shinwari
Street address
Near Andershaher, Peshawar City
City
Peshawar
Postal code
25000
Phone
+92 91 9211430
Email
drrizwanfaisal@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lady Reading Hospital
Full name of responsible person
Dr Rehana
Street address
House No. T-825, Street No. 5, Opposite
City
Peshawar
Postal code
25000
Phone
+92 333 9120587
Email
drrizwanfaisal@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lady Reading Hospital
Proportion provided by this source
10
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
Lady Reading hospital
Full name of responsible person
Dr Laiyla Shinwari
Position
FCPS Trainee
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
House No. T-825, Street No. 5, Opposite
City
Peshawar
Province
KhyberPuktunkhwa
Postal code
25000
Phone
+92 332 9022886
Email
drlailakhan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lady Reading hospital
Full name of responsible person
Dr Laiyla Shinwari
Position
FCPS Trainee
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
House No. T-825, Street No. 5, Opposite
City
Peshawar
Province
KPK
Postal code
25000
Phone
+92 91 2583455
Email
drlailakhan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Lady Reading Hospital
Full name of responsible person
Dr Laiyla Shinwari
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
House No. T-825, Street No. 5, Opposite
City
Peshawar
Province
KPK
Postal code
25000
Phone
+92 922 583455
Email
drrizwanfaisal@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Patient data related with type, gravidity, parity etc will be shared
When the data will become available and for how long
After publication of the manuscript till 1 year
To whom data/document is available
Whoever designs relevant research will be given data
Under which criteria data/document could be used
When one ensures that secrecy will be maintained will be given data
From where data/document is obtainable
one will get it by emailing me on rizwan.faisal@rmi.edu.pk
What processes are involved for a request to access data/document