Evaluation of mechanical and non-mechanical methods of cervix ripening in women with preterm rupture of membrane (PROM)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20121224011862N4

Enrollment

104

Registered

2020-10-25

Start date

2020-09-25

Completion date

Unknown

Last updated

2020-11-09

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

Conditions

Premature rupture of membranes. Premature rupture of membranes, unspecified as to length of time between rupture and onset of labor, unspecified weeks of gestation

Interventions

Intervention 1: The group under catheter intervention will use a Foley catheter size 16 with a 30 cc balloon.It will be inserted into the lower segment of the uterus using a sterile And will be filled

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Gestational age over 34 weeks with preterm rupture of membrane (PROM) Singleton pregnancy Absence of active labour Cephalic presentation Unfavorable cervix ( bishop score of 6 or less)

Exclusion criteria

Exclusion criteria: Gestational age under 34 weeks Lack of proof of preterm rupture of membrane (PROM) bleeding Contraindications to natural childbirth Finding meconium in amniotic fluid at the beginning of the intervention Suspected of chorioamnionitis intrauterine growth restriction (IUGR) Having a history of cesarean section Breech presentation Multiple pregnancies

Design outcomes

Primary

Measure	Time frame
Interval between induction commencement and obtaining bishop score of 6. Timepoint: During intervention. Method of measurement: In hour unit obtained by manual vaginal exam.	—

Secondary

Measure	Time frame
Delivery before 24 hours. Timepoint: up to 24 hours after intervention. Method of measurement: in hour unit obtained by questionnaire.;Neonatal complications. Timepoint: up to 24 hours after birth. Method of measurement: questionnaire and apgar score.;Oxytocin requirement. Timepoint: during intervention. Method of measurement: questionnaire.;Maternal complications. Timepoint: 24 hours after delivery. Method of measurement: questionnaire.;Cesarean delivery incidence. Timepoint: up to 48 hours after intervention. Method of measurement: percentage unit obtained by questionnaire.	—

Measure

Time frame

Delivery before 24 hours. Timepoint: up to 24 hours after intervention. Method of measurement: in hour unit obtained by questionnaire.;Neonatal complications. Timepoint: up to 24 hours after birth. Method of measurement: questionnaire and apgar score.;Oxytocin requirement. Timepoint: during intervention. Method of measurement: questionnaire.;Maternal complications. Timepoint: 24 hours after delivery. Method of measurement: questionnaire.;Cesarean delivery incidence. Timepoint: up to 48 hours after intervention. Method of measurement: percentage unit obtained by questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarnaz Sahaf

Tabriz University of Medical Sciences

lahroudin@gmail.com+98 35519161

Outcome results

None listed

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