Protocol summary

Summary
Background: Prolonged pregnancy associates with increased fetal and maternal complications. The necessity of fetal wellbeing testing during these pregnancies increases the costs. The need for induction of labor increases the rate of cesarean section. Acupuncture stimulates the nervous system by stimulating the parasympathetic system and increasing secretion of oxytocin from the central system, and can cause increased uterine contractility and the onset of labor. Using a safe and low cost method for initiation of labor in term pregnancy can reduce fetal and maternal complications, reduce family stress and may also reduce health care costs. Methods: This randomized double blind clinical trial is done in Shohada hospital. Inclusion criteria are singletone pregnancy , GA>38 weeks , no contraindication of vaginal delivery . Acupuncture is done for case group and sham acupuncture for control group. Routine prenatal care is done for two groups .If labor does not initiate until 42 weeks, induction with oxytocin is started. The time of labor onset , the need to induction of labor, vaginal delivery and cesarean section rate, fetal and maternal complications , Apgar score and patient satisfaction are compared between the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111218151N1
Registration date: 2011-12-26, 1390/10/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-12-26, 1390/10/05
Registrant information
Name
Ladan Ajori
Name of organization / entity
Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 1694
Email address
ajori@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti university of medical sciences
Expected recruitment start date
2011-02-25, 1389/12/06
Expected recruitment end date
2012-01-26, 1390/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of acupuncture for the initiation of labor at term pregnancy
Public title
Effectiveness of acupuncture for the initiation of labor at term pregnancy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: GA>38 w; singleton pregnancy; cephalic presentation; cervical dilatation < 3 cm; intact membrane; no history of cesarean section; no contraindication of vaginal delivery; no skin lesion on acupuncture space; no psychiatric disorders; no indication for emergency delivery; patient inform consent. Exclusion criteria: patient who wants delivery before 42 w.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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
Shahid Beheshti Blv. Yaman street, Chamran highway
City
Tehran
Postal code
Approval date
2011-02-20, 1389/12/01
Ethics committee reference number
89-01-136-7307

Health conditions studied

1

Description of health condition studied
Initiation of labor
ICD-10 code
O35.9
ICD-10 code description
Maternal care for (suspected) fetal abnormality and damage, unspecified

Primary outcomes

1

Description
Initiation of labor
Timepoint
The time between Acupuncture and initiation of labor
Method of measurement
Good contraction of uterus - Cervical dilatation

Secondary outcomes

1

Description
Neonatal Apgar
Timepoint
at last of study
Method of measurement
Apgar score

2

Description
Fetal complications
Timepoint
at last of study
Method of measurement
History, physical exam

3

Description
cesarean
Timepoint
at last of study
Method of measurement
hospital documents

4

Description
Maternal complications
Timepoint
at last of study
Method of measurement
History, physical exam

5

Description
Induction
Timepoint
at last of study
Method of measurement
hospital documents

Intervention groups

1

Description
Acupuncture (case group)
Category
Treatment - Other

2

Description
Sham Acupuncture ( control group)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti university of medical sciences
Full name of responsible person
Seyed Jalaledin Khoshnevis
Street address
Shohada Hospital - Tajrish square
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 Bheshti university of medical sciences
Full name of responsible person
Leila Nazari
Position
Gynecologist
Other areas of specialty/work
Street address
Shohada Hospital, Tajrish square
City
Tehran
Postal code
Phone
+98 21 2218 1694
Fax
Email
leynaz@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti university of medical sciences
Full name of responsible person
Ladan Ajori
Position
Gynecologist
Other areas of specialty/work
Street address
Shohada Hospital, Tajrish Square
City
Tehran
Postal code
Phone
+98 21 2205 9892
Fax
Email
leynaz@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti university of medical sciences
Full name of responsible person
Leila Nazari
Position
Gynecologist
Other areas of specialty/work
Street address
Shohada Hospital, Tajrish square
City
Tehran
Postal code
Phone
+98 21 2218 1694
Fax
+98 21 2218 1694
Email
leynaz@yahoo.com
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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