Determining the effect of outpatient vaginal administration of misoprostol to reduce the rate of postpartum pregnancy and successful induction of labor
Determine the effect of outpatient misoprostol administration on postmenopausal pregnancy and induction success
Design
Randomized clinical trial.
Settings and conduct
In this study, 90 primigravida women, referring to the Ghaem Hospital are randomly assigned to the intervention and control groups. 25 micrograms of vaginal misoprostol is administered and membrane stripping will be performed in the intervention group. If necessary, the same intervention will be done at 40th week of gestational age and then every other day until the 41th week (up to a maximum of 5 doses of misoprostol).
In the control group, the membrane stripping is done on the same days for pregnant women.
Participants/Inclusion and exclusion criteria
Entry criteria: Single-strike pregnancy, primitive gravid, cephalic presentation, normal amniotic fluid (AFI greater than or equal to 5 cm), no history of medical and obstetric and metabolic diseases, Bishop score less than 8 / reactive nst /
maternal age between 18 to 40 years / no contrindication for misoprostol / no bad history of midwifery, fetal death or infertility / lack of evidence for placenta previa or adhesion / without uterine scar / No evidence of macrosomia / No evidence of IUGR.
Exit criteria: lack of patient referral / diagnosis of pre-eclampsia after including the study
Intervention groups
Mothers of intervention group receive 25 microgram of vaginal misoprostol and membrane stripping.
Mothers of control group only receive membrane stripping.
Main outcome variables
Gestational age at delivery /the interval between the intervention and delivery / the interval between admission to delivery / maternal and neonatal outcomes including Apgar score / NICU admission / the need for resusciation /the rate of meconium aspiration / the rate of cesarean section.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180215038742N1
Registration date:2018-04-09, 1397/01/20
Registration timing:registered_while_recruiting
Last update:2018-04-09, 1397/01/20
Update count:2
Registration date
2018-04-09, 1397/01/20
Registrant information
Name
Farnaz Hadavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 3007
Email address
hadavif951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-09, 1397/01/20
Expected recruitment end date
2018-07-22, 1397/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of outpatient vaginal administration of misoprostol to reduce the rate of postpartum pregnancy and successful induction of labor
Public title
Determine the effect of prescribing of misoprostol in reducing postpartum pregnancy and delivery success
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with gestational age 39 weeks
Primigravida
Between 18 - 40 years old
Singletone pregnancy
Normal fetal heart rate
Cephalic presentation (Vertex)
AFI equal or more than 5 cm
No history of medical or midwifery disorders
Bishop score less than 8
Reactive NST
Without uterine contractions
Exclusion criteria:
Macrosomia
Sensitivity to PGs
Uterin wall scar
Preeclampsia or blood pressure more than 140/90 mmhg
PROM
Vaginal Bleeding
IUGR fetus
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to intervention or control group, using a series of opaque envelopes prepared by using random numbers generated from www.randomizer.org.
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 organization of the University, Knowledge and Health Township, Fakouri Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2017-12-13, 1396/09/22
Ethics committee reference number
IR.MUMS.fm.REC.1396.550
Health conditions studied
1
Description of health condition studied
Post-term Pregnancy
ICD-10 code
O48.0
ICD-10 code description
Post-term pregnancy
Primary outcomes
1
Description
Delivery rate before 41th week of gestational age.
Timepoint
39th week, 40th week and then every other day.
Method of measurement
newborn birth
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vaginal misoprostol (25 micrograms) in pregnant women and membrane stripping
Category
Treatment - Drugs
2
Description
Control group: membrane stripping
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Quaem hospital
Full name of responsible person
Farnaz Hadavi
Street address
Dr. Ali Shariati Sq., Ahmadabad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Email
farnazhadavi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
University compound, Azadi sqr.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 8888
Email
med.faculty@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farnaz Hadavi
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
University compound, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 8888
Fax
Email
hadavif951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sedighe Ayati
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
University compound, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 8888
Fax
Email
hadavif951@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farnaz Hadavi
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
University compound, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 8888
Fax
Email
hadavif951@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All anonymous data are shareable.
When the data will become available and for how long
One year after publication
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
For meta-analysis studies
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document