Comparison of expectant treatment outcomes in pregnant women with preterm premature rupture of membranes (PPROM) at home and hospital

Investigation of maternal and neonatal outcomes of expectant treatment in pregnant women with preterm premature rupture of membranes (PPROM) in hospital compared with expectant treatment at home

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20181115041666N1

Enrollment

100

Registered

2018-12-26

Start date

2019-04-25

Completion date

Unknown

Last updated

2019-01-14

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

Intervention 1: Control group: Expected treatment is that in the first 72 hours of hospitalization, 2 milligrams of intravenous ampicillin in every 6 hours, 500 milligram amoxicillin capsule in every

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: alive singleton pregnancy Gestational age between 25 and 34 weeks The absence of chorioamnionitis symptoms The lack of evidence for fetal distress No vaginal bleeding Patient's consent Evaluation for 72 hours in hospital Cephalic presentation Having a caretaker at home Taking 60 minutes at most to reach the first treatment center The diameter of maximum vertical pocket of the amniotic fluid is more than 2 Cm²

Exclusion criteria

Exclusion criteria: Occurrence of chorioamnionitis disturbed fetal tests of health evaluation Vaginal bleeding Patient's unwillingness to continue participation in the study Gestational age of less than 25 weeks of labor (greater than 3 cm of dilatation)

Design outcomes

Primary

Measure	Time frame
Duration of expectant treatment course. Timepoint: From hospitalization to delivery. Method of measurement: duration in days.;Gestational age at the time of delivery. Timepoint: at the time of birth. Method of measurement: Course duration is measured based on the number of weeks.;Birth weight. Timepoint: at the time of child birth. Method of measurement: using scales.;Number of cesarean section. Timepoint: Time of birth. Method of measurement: number of cesarean section in each group.	—

Measure

Time frame

Duration of expectant treatment course. Timepoint: From hospitalization to delivery. Method of measurement: duration in days.;Gestational age at the time of delivery. Timepoint: at the time of birth. Method of measurement: Course duration is measured based on the number of weeks.;Birth weight. Timepoint: at the time of child birth. Method of measurement: using scales.;Number of cesarean section. Timepoint: Time of birth. Method of measurement: number of cesarean section in each group.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamaneh Akbarzadeh

Mashhad University of Medical Sciences

Akbarzadehs941@mums.ac.ir+98 51 3801 2477

Outcome results

None listed

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