The effect of intramascular Hyoscine and Hyoscine-Promethazine on the duration of labour and deliveryoutcomes to nuliparous pregnant women(triple-blind randomize control trial)
This stady has been designed for assessment of effects of Hyoscine and Hyoscine-Promethazine on duration of labor and maternal, fetus and newborn outcomes. In this stady our inclution criteria will be 213 nulliparus wemen with/without abort in Zanjan hospitals. This study will be tripleblind (blinding of outcome assessor, patients and investigator) and will be three groups . The first group will receive 20mg(1ml) Hyoscine with 2ml distilled water(DW)(total 3ml), the second group 20mg(1ml) Hyoscine with 25mg(1ml) Promethazine+1ml DW(total 3ml) and third group(control group) 3ml DW. . Major outcomes will include to duration of active phase of labur(dilatation 4-5cm and effasment 50-60% to full dilation), maternal outcomes (kind of vaginal delivery(oprative delivery,epiziatomy with or without rupture) rupture of delivery chanel(1-4 degree), cervical laceration and uterine atonia) and fetal outcomes (tachycardia, bradycardia, loss bite to bite variability and deceleration fetal heart rate)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512163027N29
Registration date:2016-02-07, 1394/11/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-07, 1394/11/18
Registrant information
Name
Fahimeh Sehhatie Shafaie
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
sehhatief@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-04-29, 1395/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intramascular Hyoscine and Hyoscine-Promethazine on the duration of labour and deliveryoutcomes to nuliparous pregnant women(triple-blind randomize control trial)
Public title
Hyoscine and Hyoscine-Promethazine effects on the delivery
Purpose
Supportive
Inclusion/Exclusion criteria
37-41 weeks for gestational age; begining uterus contraction spontaneus; 4-5 for dillatation; 50-60% for effasman; rupture aminiotic sac befor intervention but not more than 6h past from its rupture;
one twin; nulliparous(with/without abortion in previeus pregnancy); lack of problem and sick in this pregnancy(for example preeclampsia, diabet,...); lack of controandication for normal delivery(HSV, CPD, placenta previa,... ); lack of problem in fetuse(unormal presentation); normal BMI in this pregnancy; fetus weight in normal range(2500-4000) according sonography or clinical exam; lack of major hip tightness; cephalic presentation; major height at least 150cm; mather age(18-35)
lack of glocome in mather(according to mathers statement); outgoing criteria(sensitivity to Hyoscine, unwillingness to continiue investigation, unormalfetus presentation, epidural analgisia)
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
213
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz medical university
Street address
central building, Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
tabriz
Postal code
5165665931
Approval date
2015-12-07, 1394/09/16
Ethics committee reference number
TBZMED.REC.1394.833
Health conditions studied
1
Description of health condition studied
delivery
ICD-10 code
O80.9
ICD-10 code description
Single spontaneous delivery, unspecified
Primary outcomes
1
Description
Kind of vaginal delivery, rapture of delivery canal without episiatomy, cervical laceration and uterus atonia
Timepoint
since begining intervention to 2 hours after birth
Method of measurement
check list
2
Description
total of first stage of delivery
Timepoint
since intervention to birth
Method of measurement
timer
3
Description
tachycardia, bradycardia, lost of beat to beat variability and long time deseleration in FHR
Timepoint
Since intervention to birth
Method of measurement
use of CTG
Secondary outcomes
1
Description
Total time for second and third stage of delivery
Timepoint
since camplet dilatation to delivery and exit plasenta
Method of measurement
timer
2
Description
1 and 5 appgars, need to revival, the severityof jaundice if admissed to NICU
Timepoint
since delivery to releasing mather
Method of measurement
check list
3
Description
giddiness, dizziness, tachycardia, lips dryness,fulushing of face ,headache, nausea,