Protocol summary

Study aim
Evaluation of the effect of oral hyoscine on improvement of Bishop score in first term pregnancy
Design
One hundred primiparous women referred to the Obstetrics and Gynecology Clinic of Mahdieh Hospital of Tehran were divided into two groups of oral administration of hyoscine and control (expected treatment) using randomized number table, according to the order of entry.
Settings and conduct
After obtaining a clinical history and vaginal examination of the participants, Bishop score is also calculated and recorded. Then the patients are randomly divided into two groups: hyoscine and control. At the time of admission for delivery, Bishop score is again calculated and recorded. During the course of the study, all patients were followed up by telephone, finally Bishop score, delivery time, rate late term or prolonged pregnancy, type of delivery, and neonatal characteristics were compared between the two groups.
Participants/Inclusion and exclusion criteria
Age over 18 years, primiparous, gestational age 39 weeks, 0 days to 40 weeks and 0 days, spontaneous pregnancy, single pregnancy, cephalic presentation, absence of placenta previa or placental detachment (decollement), Bishop score equal to or less than 5, absence Fetal distress, absence of IUGR or macrosomal infant (embryo weighing more than 4000 gr), no underlying disease, such as diabetes or pre-pregnancy or pregnancy hypertension, no history of cervical trauma, cervical surgery or uterine surgeries, absence of hyoscine susceptibility, no use of narcotics or analgesics, no glaucoma, no cardiovascular disease, or tachycardia with more than 100 beats per minute
Intervention groups
Group 1: taking oral hyoscine 10 mg twice daily for one week and then once a day in the second week at entering to the study (39-40 weeks) Group 2 (control): Expected treatment
Main outcome variables
Cervix status

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180819040830N1
Registration date: 2018-11-24, 1397/09/03
Registration timing: registered_while_recruiting

Last update: 2018-11-24, 1397/09/03
Update count: 0
Registration date
2018-11-24, 1397/09/03
Registrant information
Name
Zahra Naeiji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 2628
Email address
z.naeigi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral hyoscine on cervix status (Bishop score) in term pregnancy
Public title
Evaluation of the effect of oral hyoscine on the rate of cervical opening in term pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 years Primiparous Gestational age of 39 weeks and 0 days to 40 weeks and 0 days Spontaneous pregnancy Singleton pregnancy Cephalic presentation Bishop score equal to or less than 5
Exclusion criteria:
The existence of a placenta previa or placenta detachment (decollement) Fetal distress The presence of IUGR or macrosomal infant (embryo weighing more than 4000 gr) The presence of underlying illness, such as diabetes or pre-pregnancy or pre-pregnancy hypertension History of cervix trauma Hyoscine susceptibility History of cervical or uterine surgery Using narcotic drugs or analgesics The presence of glaucoma The presence of cardiovascular disease or tachycardia more than 100 beats per minute
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
A 10-by-10 table, which is randomly generated by the computer and contains numbers from 1 to 100, is used. Selecting a sample starts at the first cell from top and left of the table and goes left to right and up to down. Odds numbers are assigned to the control group and even numbers are assigned to the Hyoscine 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 Shahid Beheshti University of Medical Sciences
Street address
Next to Taleghani hospital, Shahid Arabi Ave, Yemen St., Chamran highway
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2018-09-02, 1397/06/11
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.344

Health conditions studied

1

Description of health condition studied
Pregnancy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Cervix status
Timepoint
At the time of entering the design, 24 hours later, and then every 72 hours until delivery and at the time of delivery
Method of measurement
The Bishop Score gives points to 5 measurements of the pelvic examination dilation, effacement of the cervix, station of the fetus, consistency of the cervix, and position of the cervix and its rage is 0 to 13.

Secondary outcomes

1

Description
Gestational age at delivery time
Timepoint
At delivery time
Method of measurement
Ask the patient

2

Description
Delivery type
Timepoint
At delivery
Method of measurement
Normal vaginal delivery (NVD), Cesarean section (C/S)

Intervention groups

1

Description
Intervention group: taking oral hyoscine 10 mg twice daily for one week and then once a day in the second week since entering the study (39-40 weeks)
Category
Treatment - Drugs

2

Description
Control group: Expected Treatment
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
Dr Zahra Naeigi
Street address
Mahdieh Hospital, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Fax
+98 21 5506 2628
Email
mahdieh_hospital@sbmu.ac.ir
Web page address
https://mmc.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ali Ziayee
Street address
Next to Taleghani Hospital, Shahid Arabi St., Yemen St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
msp@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Naeiji
Position
Assitant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shush squar,Tehran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Fax
Email
z.naeigi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Naeiji
Position
Assitant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shush squar,Tehran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Fax
Email
z.naeigi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Naeiji
Position
Assitant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shush squar,Tehran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Fax
Email
z.naeigi@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No need for publication
Study Protocol
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
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