Comparison of the effects of oral and sublingual and buccal Misoprostol on termination of pregnancy with preterm premature rupture of membrane
Design
clinical trial with intervention, control and parallel groups, randomized without blinding
Settings and conduct
This study is carried out without blinding on 120 women with preterm premature rupture of membrane admitted to Ommolbanin, Ghaem and Imam Reza Hospitals in Mashhad. Patients are assigned to 3 groups using simple randomization.
Participants/Inclusion and exclusion 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; bishop score of less than 6; absence of contraindication to natural childbirth and no history of uterine scar
Non-inclusion criteria : fetal macrosomia; symptoms of chorioamnionitis; use of other methods of initiating induction within the last 7 days; onset of uterine contractions
Intervention groups
Control group: prescribing 25 μg of sublingual Misoprostol every 4 hours up to a maximum of 6 doses
Intervention group 1: prescribing 50 μg of oral Misoprostol every 4 hours up to a maximum of 6 doses
Intervention group 2: prescribing 25 μg of buccal Misoprostol up to a maximum of 6 doses
Main outcome variables
the interval between induction and delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190410043237N1
Registration date:2019-04-23, 1398/02/03
Registration timing:prospective
Last update:2019-04-23, 1398/02/03
Update count:0
Registration date
2019-04-23, 1398/02/03
Registrant information
Name
Arezou Naderi Moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2477
Email address
nderima961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of oral and sublingual and buccal Misoprostol on induction of preterm premature rupture of membrane
Public title
The effect of oral and sublingual and buccal Misoprostol on induction of preterm premature rupture of membrane
Purpose
Treatment
Inclusion/Exclusion 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:
onset of uterine contractions
symptoms of chorioamnionitis
fetal macrosomia
use of other methods of initiating induction within the last 7 days
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In envelope method, envelopes with random numbers are prepared and printed with the help of ''Randomize.com'' website. Envelopes are sealed and their contents are not visible from the outside. Firstly, the purpose of the study is explained to the individuals who meet the mentioned conditions. If willing, he/she signs the informed consent form and takes an envelope and opens it and based on its content, will enter either the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-02-05, 1397/11/16
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.774
Health conditions studied
1
Description of health condition studied
Preterm premature rupture of the membranes
ICD-10 code
O42
ICD-10 code description
Premature rupture of membranes
Primary outcomes
1
Description
the interval between initiation of induction and delivery
Timepoint
after the intervention
Method of measurement
patient's file
Secondary outcomes
1
Description
natural delivery or cesarean section
Timepoint
after the intervention
Method of measurement
based on file
2
Description
investigation of Misoprostol side-effects
Timepoint
after medication use
Method of measurement
based on clinical observations
3
Description
investigation of maternal complications such as postpartum hemorrhage
Timepoint
after delivery
Method of measurement
based on clinical observations
4
Description
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
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
Intervention group2: prescribing 25 μg of buccal Misoprostol up to a maximum of 6 doses
Category
Treatment - Drugs
3
Description
Control group: prescribing 25 μg of sublingual Misoprostol every 4 hours