The effect of zinc supplementation on prevention of preterm premature rupture of the membranes

The effect of zinc supplementation on prevention of preterm premature rupture of the membranes in high risk pregnant women: a randomized controlled clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201311296709N14

Enrollment

108

Registered

2014-08-05

Start date

2014-07-23

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm premature rupture of membranes. Premature rupture of membranes

Interventions

Prevention

Intervention 1: 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. Intervention 2: Contro

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

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

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion 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)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Preterm premature rupture of the membranes. Timepoint: 20 to 37 weeks. Method of measurement: View sterile Speculum and Nitrazine test.	—

Secondary

Measure	Time frame
Gestational age. Timepoint: Delivery time. Method of measurement: By last menstrual period date and sonography.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShiva Azimi

Tabriz University of Medical Sciences

shivaazimi66@yahoo.com+98 41 1479 6770

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026