Protocol summary
-
Study aim
-
Evaluation of the effect of oral probiotics on pregnancy outcomes in pregnant women undergoing cerclage compared with placebo
-
Design
-
clinical trial with control group; With Parallel groups; One blinded; randomized; design of 104 patients
-
Settings and conduct
-
Eligible patients entering the study referred to Imam Sajjad Hospital of Yasuj University of Medical Sciences will be divided into two groups of 52 people and the consequences of preganncy will be measured.
-
Participants/Inclusion and exclusion criteria
-
Patient age 18-45 years
Gestational age between 14-24 weeks
Cerclage by McDonald method
Absence of syphilis, gonorrhea and HIV clinically
Single pregnancy
Lack of maternal insulin-dependent diabetes mellitus, treatment of hypertension, lupus
No clinical chorioamnionitis
Desire to participate in the study
Any genital or urinary tract infection requires antibiotic treatment during treatment
-
Intervention groups
-
Group A (cerclage plus lactofem): Lactofem capsule (500 mg) made by Iranian zist-takhmir Company will be administered orally and daily from the day of cerclage until the end of pregnancy.
Group B (cerclage with placebo): Placebo drug is very similar to group A with the same method, the duration of treatment will be prescribed. The placebo drug will be prepared by a zist-takhmir company similar to probiotics.
-
Main outcome variables
-
Premature preterm birth (less than 34 weeks gestation), late preterm birth (34-37 weeks gestation), premature rupture of amniotic sac, type of delivery (normal and cesarean section)
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20160524028038N11
Registration date:
2021-04-29, 1400/02/09
Registration timing:
registered_while_recruiting
Last update:
2022-12-04, 1401/09/13
Update count:
1
-
Registration date
-
2021-04-29, 1400/02/09
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-09-24, 1399/07/03
-
Expected recruitment end date
-
2021-09-11, 1400/06/20
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The effect of oral probiotics on pregnancy outcomes in pregnant women undergoing cerclage compared with placebo
-
Public title
-
Oral probiotics and cerclage
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Patient age 18-45 years
Gestational age between 14-24 weeks
Cerclage by McDonald method
Absence of syphilis, gonorrhea and HIV clinically
Single pregnancy
Lack of maternal insulin-dependent diabetes mellitus, treatment of hypertension, lupus
No clinical chorioamnionitis
Exclusion criteria:
Reluctance to participate in the study
Failure to complete the course of treatment or use of probiotics
Taking drugs that affect the intestinal microbial flora, such as antibiotics
Occurrence of any genital or urinary tract infection requires antibiotic treatment during treatment
-
Age
-
From 18 years old to 45 years old
-
Gender
-
Female
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
104
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software; Sequence Building: Using randomized in 4 blocks; Hiding method: Use envelopes in the package
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-09-23, 1399/07/02
-
Ethics committee reference number
-
IR.YUMS.REC.1399.130
Health conditions studied
1
-
Description of health condition studied
-
Cervical insufficiency
-
ICD-10 code
-
O00-O08
-
ICD-10 code description
-
Pregnancy with abortive outcome
Primary outcomes
1
-
Description
-
Premature preterm birth (less than 34 weeks gestation)
-
Timepoint
-
End of intervention
-
Method of measurement
-
Questionnaire
2
-
Description
-
Late preterm birth (34-37 weeks gestation)
-
Timepoint
-
End of intervention
-
Method of measurement
-
Questionnaire
3
-
Description
-
Premature rupture of amniotic sac,
-
Timepoint
-
End of intervention
-
Method of measurement
-
Questionnaire
4
-
Description
-
Type of delivery (normal and cesarean section)
-
Timepoint
-
End of intervention
-
Method of measurement
-
Questionnaire
Intervention groups
1
-
Description
-
Intervention group(cerclage plus lactofem): Lactofem capsule (500 mg) made by Iranian zist-takhmir Company will be administered orally and daily from the day of cerclage until the end of pregnancy.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group (cerclage with placebo): Placebo drug is very similar to group A with the same method, the duration of treatment will be prescribed. The placebo drug will be prepared by Medicinal Plants Laboratory, Yasouj University of Medical Sciences similar to probiotics.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Yasouj 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
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
-
No more information
-
Study Protocol
-
No - There is not a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available