The effect of zinc supplementation on prevention of preterm premature rupture of the membranes in high risk pregnant women: a randomized controlled clinical trial
The aim of this randomized controlled trial (double blind) is to examine the effect of zinc supplementation on prevention of premature rupture of the membranes in high risk pregnant women. In this study, 108 pregnant women aged above 18 years with 16 -20 weeks of gestation, referring to maternal clinics of selected hospitals affiliated in Tehran, who has at least one previous preterm premature rupture of the membranes, will be recruited. Eligible women will be selected through convenience sampling and will be randomly assigned into 2 groups using permuted block randomization with allocation ratio of 1:1. Random allocation sequence will be determined using a computerized program. Opaque sealed sequentially numbered envelopes from number 1 to 108 will be used for allocation concealment. Each women according to integrated maternal health care program in two weeks (16-20) and (26-30) opacity closed envelope will be given, which contains 84 tablets. Thus intervention group will receive one zinc sulfate (40 mg) tablet daily and control group will receive one placebo tablet daily until delivery. Gestational age during of preterm premature rupture of the membranes will be measured. In addition, checklist about possible complications and daily consumption of tablets will be completed by participants and checklist of information about delivery and birth will be completed by the investigator. The researcher and the participants will be blind about allocation to each group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311296709N14
Registration date:2014-08-05, 1393/05/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-05, 1393/05/14
Registrant information
Name
Mahnaz Shahnazi
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
mshahnazi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Tabriz University of Medical Science
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-02-04, 1393/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of zinc supplementation on prevention of preterm premature rupture of the membranes in high risk pregnant women: a randomized controlled clinical trial
Public title
The effect of zinc supplementation on prevention of preterm premature rupture of the membranes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the history of preterm premature rupture of the membranes at least once in previous pregnancies; singleton pregnancy; normal fetus and amniotic fluid; maternal age 18 years and above; gestational age between 16 and 20 weeks of pregnancy; healthy women without underlying medical condition (cardiac, pulmonary, gastrointestinal, diabetes, epilepsy, hypertension, etc); willingness to participate in the study. Exclusion criteria: the uncertain status of the embryo (abnormal non stress test ); any congenital anomalies of the fetus; any complications of pregnancy (history of preeclampsia and current chronic hypertension, bleeding and threatened abortion, nausea and vomiting, etc ); having an addiction to drugs and alcohol; taking multivitamin mineral supplementation during pregnancy; severe vaginal infection (with discharge, itching, swelling, erythema, and foul-smelling discharge)
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
108
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 committee of Tabriz university of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
East Azarbaijan
Postal code
Approval date
2014-04-28, 1393/02/08
Ethics committee reference number
9316
Health conditions studied
1
Description of health condition studied
Preterm premature rupture of membranes
ICD-10 code
042
ICD-10 code description
Premature rupture of membranes
Primary outcomes
1
Description
Preterm premature rupture of the membranes
Timepoint
20 to 37 weeks
Method of measurement
View sterile Speculum and Nitrazine test
Secondary outcomes
1
Description
Gestational age
Timepoint
Delivery time
Method of measurement
By last menstrual period date and sonography
Intervention groups
1
Description
Intervention group: tablet of zinc sulfate made by faculty of pharmacy in Tabriz, containing 40 mg zinc, one oral pill daily from 16 to 20 weeks until delivery
Category
Prevention
2
Description
Control group: tablet placebo made by pharmacy faculty in Tabriz, Containing 40 mg Micro Crysttaline Cellulose , one oral pill daily from 16 to 20 weeks until delivery