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Misoprostol versus foley catheter for cervical ripening in women with preeclampsia or gestational hypertension.

Protocol summary

Summary
The aim of this study is to compare the effect of misoprostol and foley catheter in cervical ripening among pregnant women with preeclampsia or gestational hypertension. The primary outcome was the interval between the commencement of induction and obtaining bishop score of 6 (induction to ripened cervix interval) and the secondary outcome included: maternal and neonatal complications, oxytocin requirement, delivery before 24 hours, duration of the second stage of delivery, cesarean delivery incidence in each of cervical ripening methods. Therefore, this interventional study was designed as a randomized control trial which was non-blinded and parallel. Inclusion criteria were pregnant women with preeclampsia or gestational hypertension and singleton pregnancies, gestational age of 26 weeks or more, absence of active labour, cephalic presentation, unfavorable cervix (bishop score of 6 or less), normal FHR and intact membrane. Exclusion criteria were hypersensitivity to Prostaglandins, previous Cesarean section or previous uterine scar, macrosomia, lethal congenital anomalies and placenta previa. According to this, a total number of 125 women were randomly divided into two groups. The misoprostol group (n=54) and the Foley catheter group (n=71). In group one, 25 µg of misoprostol tablet was administrated sublingually every 4 hours up to maximum dose of 6. In group two, a 16F Foley catheter was placed through the internal os of the cervix under aseptic condition and then inflated with 60 cc of sterile saline.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017010731725N1
Registration date: 2017-02-20, 1395/12/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-20, 1395/12/02
Registrant information
Name
Elahe Hassanzadeh
Name of organization / entity
mashhad university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+93 5138677091
Email address
hassanzadehe871@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-01-01, 1393/10/11
Expected recruitment end date
2017-01-01, 1395/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Misoprostol versus foley catheter for cervical ripening in women with preeclampsia or gestational hypertension.
Public title
Comparison between Misoprostol and foley catheter for cervical ripening.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- pregnant women with preeclampsia or gestational hypertension 2- Singleton pregnancy 3- Gestational age of 26 weeks or more 4- Absence of active labour 5- Cephalic presentation 6- Unfavorable cervix ( bishop score of 6 or less) 7- Normal FHR 8- Intact membrane. Exclusion Criteria: 1- Hypersensitivity to Prostaglandins 2- Previous Cesarean section 3- Previous uterine scar 4- Macrosomia 6- lethal congenital anomalies 7- Placenta previa.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 125
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethic Committee of Mashhad University of Medical Sciences
Street address
Daneshgah Street, Ghoreishi building
City
Mashhad
Postal code
Approval date
2015-11-07, 1394/08/16
Ethics committee reference number
IR.MUMS.REC.1394.498

Health conditions studied

1

Description of health condition studied
preeclampsia
ICD-10 code
O14.9
ICD-10 code description
Pre-eclampsia, unspecified

2

Description of health condition studied
gestational hypertention
ICD-10 code
O13
ICD-10 code description
Gestational [pregnancy-induced] hypertension without significant proteinuria

Primary outcomes

1

Description
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 outcomes

1

Description
delivery before 24 hours
Timepoint
up to 24 hours after intervention
Method of measurement
in hour unit obtained by questionnaire

2

Description
neonatal complications
Timepoint
up to 24 hours after birth
Method of measurement
questionnaire and apgar score

3

Description
oxytocin requirement
Timepoint
during intervention
Method of measurement
questionnaire

4

Description
maternal complications
Timepoint
24 hours after delivery
Method of measurement
questionnaire

5

Description
duration of the second stage of delivery
Timepoint
maximum 3 hours after complete dilatation and effacement
Method of measurement
in minute unit obtained by questionnaire

6

Description
cesarean delivery incidence
Timepoint
up to 48 hours after intervention
Method of measurement
percentage unit obtained by questionnaire

Intervention groups

1

Description
In misoprostol group: 25 micro grams of misoprostol tablet was administered sublingually every 4 hours up to maximum dose of 6 during cervical ripening.
Category
Treatment - Drugs

2

Description
In foley catheter group: A 16 F foley catheter was inserted through internal os of cervix under aseptic condition and it was inflated with 60 cc of sterile salin. This intervention was performed during cervical ripening and was ejected spontaneously or according to physician order or after 24 hours.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Qaem Hospital
Full name of responsible person
Street address
City
Mashhad

2

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research assistance of Mashhad University of Medical Sciences
Full name of responsible person
Hadi Mousavi
Street address
Azadi Square, Medical College
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research assistance of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elahe Hassanzadeh
Position
Medical Student
Other areas of specialty/work
Street address
Azadi Square, Medical College
City
Mashhad
Postal code
Phone
+98 513867791
Fax
Email
hassanzadehe871@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad university of medical Sciences
Full name of responsible person
Leila Pourali
Position
Assistant Professor
Other areas of specialty/work
Street address
Qaem Hospital
City
Mashhad
Postal code
Phone
+98 51 3841 7493
Fax
Email
pouralil@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elahe Hassanzadeh
Position
Medical Student
Other areas of specialty/work
Street address
Azadi Square, Medicine College
City
Mashhad
Postal code
Phone
+98 51 3867 7091
Fax
Email
hassanzadehe871@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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