Comparison of effects of transcutaneous electrical nerve stimulation and of pharmaceutical hyoscine– promethazine compound on duration of the second phase of labor
This research is a randomly clinical 2-group ergometric one done in order to compare effects of TENS with those of hyoscine-promethazine compound on duration of the second stage of labor. At the onset of active labor phase (4-cm dilatation), medication group subject were injected once intramuscularly by 20 mg of hyoscine and 25 mg of promethazine simultaneously. For TENS group, was used with 1 pair of upper electrodes placed between L1-T10 and 1 pair of lower electrodes placed between S2-S4 apart 7 cm from both side of spinal column. Tens being on/off for 20 min/20 min until the second phase of labor(10cm dilatation) completed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604144317N10
Registration date:2017-03-14, 1395/12/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-14, 1395/12/24
Registrant information
Name
Fatemeh Nahidi
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 982188202512
Email address
nahidi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of transcutaneous electrical nerve stimulation and of pharmaceutical hyoscine– promethazine compound on duration of the second phase of labor
Public title
delivery
Purpose
Treatment
Inclusion/Exclusion criteria
1. Being of Iranian race;
2. The first and /or the second labor;
3. Being 18-35 years of old;
4. Term pregnancy, single-twin, and presentation of fetus head;
5. Onset of spontaneous contractions;
6. Dilatation examination upon arrival at 3-4 cm;
7. Minimum education level of elementary grade 5;
8. Not taking painkillers 3 hours before and during study;
9. Mot more than 6 hours passed after caul rupture;
10. Lack of experience with TENS;
11. No epilepsy;
12. No cardiac pacemakers;
13. No use of substance/ drugs; and
14. No skin lesions or surgical scars at the place of electrodes.
And followings are criteria for women ti be excluded from the study;
1. Emergency caesarean prior to the study completion; research;
2. Occurrence of such labor complications as vaginal bleeding during research;
3. Patients reluctance to continue participating in the study; and
4. Wounds or scars present at the place of electrodes.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
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
shahid beheshti university of medical sciences
Street address
tehran
City
tehran
Postal code
Approval date
2015-07-28, 1394/05/06
Ethics committee reference number
ir.sbmu.phnm.1394.43
Health conditions studied
1
Description of health condition studied
delivery
ICD-10 code
xv
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
pain intensity
Timepoint
At 4-5 cm, 6-7 cm, 8-9cm, 10cm
Method of measurement
pain visual scale
Secondary outcomes
1
Description
duration of the first phase of labor
Timepoint
duration of the first phase((upon arrived until 10-cm dilatation)
Method of measurement
wristwatch
2
Description
duration of the second phase of labor
Timepoint
second phase (from 10-cm dilatation to the fetus exit)
Method of measurement
wristwatch
Intervention groups
1
Description
At the onset of active labor phase (4-cm dilatation), medication group subject were injected once intramuscularly by 20 mg of hyoscine and 25 mg of promethazine simultaneously.
Category
Treatment - Drugs
2
Description
For TENS group, was used with 1 pair of upper electrodes placed between L1-T10 and 1 pair of lower electrodes placed between S2-S4 apart 7 cm from both side of spinal column. Tens being on/off for 20 min/20 min until the second phase of labor(10cm dilatation) completed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Martyr Chamran Hospital of Kangavar
Full name of responsible person
Massumeh Payandeh
Street address
City
Kangavar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shahid beheshti university of medical sciences
Full name of responsible person
Massumeh Payandeh
Street address
tehran
City
tehran
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
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
shahid beheshti university of medical sciences
Full name of responsible person
fateme nahidi
Position
phd
Other areas of specialty/work
Street address
faculty nursing & midwifery
City
tehran
Postal code
Phone
+218 8202512
Fax
Email
nahidi@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
shahid beheshti university of medical sciences
Full name of responsible person
Masumeh Payandeh
Position
master of midvifery
Other areas of specialty/work
Street address
tehran
City
tehran
Postal code
Phone
+218 8202512
Fax
Email
m_paiande@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Masumeh Payandeh
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
008348238714
Fax
Email
m_paiande@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)