The effect of oral and sublingual and buccal Misoprostol on induction of preterm premature rupture of membrane

Comparison of the effects of oral and sublingual and buccal Misoprostol on induction of preterm premature rupture of membrane

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190410043237N1

Enrollment

120

Registered

2019-04-23

Start date

2019-05-22

Completion date

Unknown

Last updated

2019-05-21

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

Conditions

Preterm premature rupture of the membranes. Premature rupture of membranes

Interventions

Intervention 1: Intervention group: prescribing 50 µg of oral Misoprostol (one fourth of 200-µg misoprostol poduced by SAMISAZ pharmaceutical company) every 4 hours up to a maximum of 6 doses. Interve

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: women with single pregnancy preterm premature rupture of membrane gestational age of 37-42 weeks cephalic presentation informed consent of the individual to enter the study low risk pregnancy (no complications such as preeclampsia and gestational diabetes and heart diseases) satisfactory fetal heart rate patterns absence of contraindication to natural childbirth and no history of uterine scar bishop score of less than 6

Exclusion criteria

Exclusion criteria: onset of uterine contractions symptoms of chorioamnionitis fetal macrosomia use of other methods of initiating induction within the last 7 days

Design outcomes

Primary

Measure	Time frame
The interval between initiation of induction and delivery. Timepoint: after the intervention. Method of measurement: patient's file.	—

Secondary

Measure	Time frame
Natural delivery or cesarean section. Timepoint: after the intervention. Method of measurement: based on file.;Investigation of Misoprostol side-effects. Timepoint: after medication use. Method of measurement: based on clinical observations.;Investigation of maternal complications such as postpartum hemorrhage. Timepoint: after delivery. Method of measurement: based on clinical observations.;Investigation of neonatal complications such as Apgar Score, dystocia, ICU hospitalization , Sepsis and bacteremia. Timepoint: Immediately after the birth of the infant. Method of measurement: based on clinical observations.	—

Measure

Time frame

Natural delivery or cesarean section. Timepoint: after the intervention. Method of measurement: based on file.;Investigation of Misoprostol side-effects. Timepoint: after medication use. Method of measurement: based on clinical observations.;Investigation of maternal complications such as postpartum hemorrhage. Timepoint: after delivery. Method of measurement: based on clinical observations.;Investigation of neonatal complications such as Apgar Score, dystocia, ICU hospitalization , Sepsis and bacteremia. Timepoint: Immediately after the birth of the infant. Method of measurement: based on clinical observations.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactArezou Naderi Moghadam

Mashhad University of Medical Sciences

naderima961@mums.ac.ir+98 51 3223 1444

Outcome results

None listed

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