Investigating the effect of vaginal washing before Misoprostol insertion on cervical ripening before labor induction
Design
Clinical trials with control group, with parallel groups, double blind, randomized
Settings and conduct
The subjects were pregnant women with single-pregnant women undergoing pregnancy termination are admitted to Al-Zahra Hospital in Rasht, Iran, which were selected according to inclusion criteria. After giving explanations to individuals, they are randomly divided into two groups. And will be unaware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria include all pregnant women with singleton pregnancy and candidates for termination of pregnancy.
Exclusion criteria include occurrence of any complications requiring cesarean section termination.
Intervention groups
The intervention group includes pregnant women who receive vaginal washing with normal saline prior to misoprostol loading.
The control group includes pregnant women who will receive only misoprostol suppositories.
Main outcome variables
The interval between misoprostol insertion Until the delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080826001096N7
Registration date:2019-08-18, 1398/05/27
Registration timing:registered_while_recruiting
Last update:2019-08-18, 1398/05/27
Update count:0
Registration date
2019-08-18, 1398/05/27
Registrant information
Name
Seyede Hajar Sharami
Name of organization / entity
Guilan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
sharami@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of vaginal washing before Misoprostol insertion on ripening cervix before labor induction
Public title
Investigating the effect of vaginal washing before Misoprostol insertion on ripening cervix before labor induction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
pregnant women ages 18 to 40
Having 38 to 40 week pregnancy
Having singleton pregnancy
Having normal fetal heart rate (FHR)
Having cephalic presentation
Not having a ban on normal vaginal delivery (cephalopelvic disproportion)
Having no uterine contractions spontaneously and effectively (less than three contractions in 30 minutes)
Having a Bishop score of less than 6
Estimation of fetal weight less than 4000 grams
Candidates for termination of pregnancy (post-term pregnancy (42 weeks and more), oligohydramnios, decreased fetal movements, abdominal biophysical profile score, maternal diabetes mellitus, intrauterine growth retardation, and preeclampsia)
Exclusion criteria:
Having sensitivity to known prostaglandin (with questions like skin manifestations, hives and rash, dyspnea and coughing, chest pain and blurred vision after taking prostaglandin)
Having vaginal bleeding
Preterm rupture of membranes
Having a history of previous cesarean section or scar on the uterus
Having fetal anomaly
Having doubts about Chorioamnionitis
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
164
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals are assigned blocked randomization size of 4 in sealed envelopes.The patients will be divided into two groups: vaginal washing (A) and control group (without vaginal washing) (B).
Random sequences will be generated by computer software.
After generating the list, each individual will be assigned a dedicated code and will be identified with this code during the study.
The registration and randomization sequence are done by a resident of obstetric and gynecology.
None of the participating in the study will be aware of the randomization list .
Registration and randomization sequence are done by a third party.
Blinding (investigator's opinion)
Single blinded
Blinding description
None of the participating in the study will be aware of the randomization list and also
sealed envelopes that are numbered sequentially will be used for allocation concealment the randomization process. and envelope relating to each individual only after confirming the eligibility criteria for entry into study for him and the signature of the consent will be opened form by individual.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Research vice-chancellorship Building, in front of 17-Shahrivar Hospital, Shahid Siadati St., Namjoo Ave., Rasht, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
66949- 41446
Approval date
2019-06-15, 1398/03/25
Ethics committee reference number
IR.GUMS.REC.1398.107
Health conditions studied
1
Description of health condition studied
Labor induction
ICD-10 code
O61.8
ICD-10 code description
Other failed induction of labour
Primary outcomes
1
Description
success of labor induction
Timepoint
Post-partum
Method of measurement
Duration from induction to active phase of labor
Secondary outcomes
1
Description
The duration of vaginal Misoprostol to successful labor induction
Timepoint
During labor
Method of measurement
hour
2
Description
Vaginal PH
Timepoint
Before and after vaginal washing
Method of measurement
Nitrazine paper
3
Description
Duration from induction to end of first stage of labor
Timepoint
During labor until the end of the first stage of labor
Neonatal complications include meconium excretion, Apgar score less than 7, admission to the NICU
Timepoint
During labor until after delivery
Method of measurement
Observations by doctor
Intervention groups
1
Description
Intervention group: : Vaginal washing with normal saline 0.9%(20 cc) is performed once before Misoprostol insertion (25 micrograms vaginal in the fornix posterior vaginal ) with a syringe.
Category
Treatment - Drugs
2
Description
Control group: Without vaginal washing, only Misoprostol suppository will be inserted (25 micrograms vaginal into the fornix posterior vaginal ) .
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Total data can be shared after people are unidentifiable.
When the data will become available and for how long
From 2020 for two years
To whom data/document is available
All people interested in academic and scientific institutions
Under which criteria data/document could be used
Contract between the two sides
From where data/document is obtainable
Dr. seyedeh Hajar sharami
009813133369224
Rasht, Namju street, Al-Zahra hospital
What processes are involved for a request to access data/document
After email or phone call with Dr. Sharemi and if possible face to face meeting and after contract to determination the scope of authorities, the data will be available to the applicant.
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