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

Phase 2

Recruiting

• 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; O42.90

• Registration Number: IRCT20121224011862N4
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 104

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.