Comparision of maintenance therapy and continuous intravenous therapy with magnesium sulfate in preterm labor pain management at 24-36 weeks gestation: a randomized controlled trial
The main objectivein of this single blind randomized clinical trial is comparision of maintenance therapy and continuous intravenous therapy with magnesium sulfate in preterm labor pain management.The study population are all of the patients with gestational age of 26 to 34 weeks. patients with at least 4 uterus contraction during 20 min and cervical dilatation below 4 cm and effacement less than 80% will enter in the study.The study sample size was 70 patients. Informed consent will be obtained from the participants they and will be randomly assigned to received with 4gr MS in 200cc D/W 5% during 15 to 20 minutes either infusion therapy with 20 gr MS in 10 hours (group A) or maintenance therapy with 2gr/hr MS for 12 hours (group B).Patients who will not response to magnesium sulfate within 2 h , will be excluded.We will assess the success rate in both groups for stopping labor pain, NICU admission, pregnancy duration and APGAR score at 5 min.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112913932N2
Registration date:2013-12-14, 1392/09/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-14, 1392/09/23
Registrant information
Name
Seyed Shojaeddin Namazi
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 1333 4190
Email address
ssh.namazi@gmail.com
Recruitment status
Recruitment complete
Funding source
Research council of Hormozgan University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of maintenance therapy and continuous intravenous therapy with magnesium sulfate in preterm labor pain management at 24-36 weeks gestation: a randomized controlled trial
Public title
the efficace of magnesium sulfate in preterm labor pain managment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:gestational age of 24 - 36 weeks;the presence of atleast 4 uterus contraction during 20 min; dilatation below 4 cm; effacement less than 80%
Exclusion criteria:coexistense of medical disease such as diabetes mellitus; asthma; cardiovascular disease; preeclampsia; uterine bleeding; rupture of membrane; placenta decolman; intruterine infections; UTI; fetus anomalies; previous preterm labor pain; lack of decreasing uterus contractions during 2 first hr after administration of magnesium sulfate; The patient need to administration of magnesium sulfate after 24 h.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
student research committee, Hormozgan University of Medical Sciences
Street address
Student Research Committee, Research Council, Shahid Mohammadi Hospital, Jomhoori Eslami Blvd Bandar Abbas Hormozgan Iran, Islamic Republic Of
City
Bandar Abbas
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
88-92/29
Health conditions studied
1
Description of health condition studied
preterm labour pain
ICD-10 code
O60.1
ICD-10 code description
Preterm spontaneous labour with preterm delivery
Primary outcomes
1
Description
controlling uterine contraction
Timepoint
during intervention- 24 h after intervention
Method of measurement
checking uterine contraction by hand
2
Description
preterm delivery
Timepoint
just after intervention- 48 h after intervention
Method of measurement
, delivery before 37 weeks of gestation
Secondary outcomes
1
Description
duration of pregnancy
Timepoint
during and after intervention
Method of measurement
day
2
Description
Duration of neonatal admission in NICU
Timepoint
after intervention
Method of measurement
day
Intervention groups
1
Description
The patients in group A, will be received 4gr magnesium sulfate in 200cc D/W 5% during 15 to 20 minutes and then infusion of 20 gr magnesium sulfate during 10 hours (2gr/h)
Category
Treatment - Drugs
2
Description
The patients in group B, will be received 4gr magnesium sulfate in 200cc D/W 5% during 15 to 20 minutes and then continues infusion of 2gr/hr magnesium sulfate for 12 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fertility and infertility research center
Full name of responsible person
Seyed Shojaeddin Namazi
Street address
Fertility and infertility research center build. Shariati Hospital, Madar blvd. Bandar Abbas, Hormozgan.
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Abdolazim Nejatizadeh (Vice Chancellor of research Hormozgan University of Medical Sciences)
Street address
Research Council build., Shahid Mohammadi Hospital, Jomhoori Eslami Blvd
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Seyed Shojaeddin Namazi
Position
Student
Other areas of specialty/work
Street address
Student Research Committee, Research Counci Build., Shahid Mohammadi Hospital, Jomhoori Eslami Blvd.
City
Bandar Abbas
Postal code
Phone
+98 76 1335 0218
Fax
+98 74 1333 4190
Email
ssh.namazi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Seyed Shojaeddin Namazi
Position
Student
Other areas of specialty/work
Street address
Student Research Committee, Research Counci Buildingl, Shahid Mohammadi Hospital, Jomhoori Eslami Blvd.
City
Bandar Abbas
Postal code
Phone
+98 76 1335 0218
Fax
+98 74 1333 4190
Email
ssh.namazi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)