Comparison of early amniotomy and put amniotic sac in its own on the risk of dystocia in nulliparous women attending to Khorram Abad Assail hospital in 1392.
Recently, early amniotomy has been supported to prevention of dystocia in spontaneous labour, but there is disagreement about amniotomy performed routinely or not for expedited delivery.In our study we find that routine early amniotomy for Nulliparous women versus put amniotic sac in its own reduce risk of dystosia or not? in addition we study other related items such as duration of labour, cord prolapse and placental abruption. in this clinical trial study, sampeling will perform convenience. sampling will consisted of 300 people. the study population is all of the nulliparous women that referred to hospital with spontaneous onset of labour that have inclution criteria. they are divided randomly into 2 groups: control and case. in case group early amniotomy at 4 CM will perform and in control group put amniotic sac in its own and we compare dystosia in two groups.basic inclusion criteria is: nulliparity, spontaneous onset of labour ,exclusion criteria is each type of baseline disease in mother and fetus.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013080114123N1
Registration date:2013-09-15, 1392/06/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-09-15, 1392/06/24
Registrant information
Name
Samira Moiini Nasab
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1337 0277
Email address
zibaei.m@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences
Expected recruitment start date
2013-09-19, 1392/06/28
Expected recruitment end date
2013-12-06, 1392/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of early amniotomy and put amniotic sac in its own on the risk of dystocia in nulliparous women attending to Khorram Abad Assail hospital in 1392.
Public title
Early amniotomy in nulliparous women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: nulliparity; single fetus; term gestational age(37 W+0day-42Weeks); Blood pressur <140/90; spontaneus onset of labour; cephalic presentation; intact amniotic memberans; normal fetal heart rate
Exclution criteria: 40<age>18; intra uterine growth retardation; pre eclampsia; underline disease for exampie DM; servical dilatation≥ 4 cm.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
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
Lorestan University of Medical Sciences
Street address
Lorestan University of Medical Siences, University Complex Kamalvand, Khorramabad, Lorestan.
City
Khorramabad
Postal code
Approval date
2013-05-22, 1392/03/01
Ethics committee reference number
200/85956
Health conditions studied
1
Description of health condition studied
dystosia
ICD-10 code
066.4
ICD-10 code description
Failed trial of labour, unspecified
Primary outcomes
1
Description
dystosia
Timepoint
delivery time
Method of measurement
Determined by obstetricians or midwives
Secondary outcomes
1
Description
time of delivery
Timepoint
during delivery
Method of measurement
Determined by obstetricians or midwives
2
Description
type of delivery
Timepoint
eduring delivery
Method of measurement
Determined by obstetricians or midwives
3
Description
cord prolapse
Timepoint
during delivery
Method of measurement
Determined by obstetricians or midwives
4
Description
placental abruption
Timepoint
during delivery
Method of measurement
Determined by obstetricians or midwives
Intervention groups
1
Description
in control group: put amniotic sac in its own
Category
Prevention
2
Description
in Intervention group underwent amniotomy will be at 4 cm dilation.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
khorram Abad Assail hospital
Full name of responsible person
Masome Ghafar Zade
Street address
Assaly khorram abad charity hospital, Pelestin street, Khorram abad, Lorestan.
City
Khorram abad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Mohamad Hasan Kaedi
Street address
Lorestan Univercity of Medical Siences,Academic Complex Kamalvand, kilometer 5 khorram abad road Tehran, Khorram abad,Lorestan.
City
Khorram abad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan 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
Lorestan University of Medical Sciences
Full name of responsible person
Masome Ghafar Zade
Position
Gynecologist
Other areas of specialty/work
Street address
Lorestan univercity of Medical Siences,Academic Complex Kamalvand, kilometer 5 Khorram abad road Tehran, Khorram abad, Lorestan.
City
Khorramabad
Postal code
Phone
+98 66 1221 5744
Fax
Email
masome hgafar zade@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khorram abad University of Medical Sciences
Full name of responsible person
Masome Ghafar Zade
Position
Gynecologist
Other areas of specialty/work
Street address
Lorestan Univercity of Medical Siences,Academic Complex Kamalvand, kilometer 5 Khorram abad road Tehran, Khorram abad, Lorestan.
City
Khorram abad
Postal code
Phone
+98 66 1221 5744
Fax
Email
masomeghafarzade@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Masome Ghafar Zade
Position
Gynecologist
Other areas of specialty/work
Street address
Lorestan Univercity of Medical Siences,Academic Complex Kamalvand, kilometer 5 Khorram abad road Tehran, Khorram abad, Lorestan.
City
Khorram abad
Postal code
Phone
+98 66 1221 5744
Fax
Email
masomeghafarzade@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)