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Comparison of the effectiveness of local administration of magnesium sulfate in the latent phase of labor on the improvement of effacement, dilatation, and duration of labor in primiparous and multiparous women

Protocol summary

Study aim
Comparison of the effectiveness of local administration of magnesium sulfate in the latent phase of labor on the improvement of effacement, dilatation, and duration of labor in primiparous and multiparous women
Design
The clinical trial has a control group, with parallel groups, double-blind, randomized, phase 3, which will be conducted on 75 women admitted in the delivery room of Ayatollah Mousavi Hospital in Zanjan. People will be assigned to two intervention groups and one control group using a random sampling method of 6 blocks.
Settings and conduct
The setting is the delivery room of Ayatollah Mousavi Hospital in Zanjan. The samples will be allocated to two intervention groups and one control group by a random block method of 6. The intervention group will receive ten cc of 50% magnesium sulfate in the latent phase of labor. Distilled water will be used for the placebo group with the same prescription. The study will be double-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria Pregnant women with a singleton pregnancy, The cephalic presentation, Gestational age 42 - 37 weeks, Age of women between 18-35 years, Spontaneous start of labor, Dilatation less than 3 cm, Body mass index between 19.8 and 30 kg/m2, Low-risk pregnancy Exclusion criteria Receiving infertility treatments, multiple pregnancies, History of heart disease, Having a history of a severe allergy to magnesium sulfate, The existence of contraindications for natural childbirth
Intervention groups
Ten cc of 50% magnesium sulfate (up to two doses) will be poured between the fingers on the cervix during the vaginal examination during the latent phase of labor to cover the entire cervix. Distilled water will be used for the placebo group with the same prescription.
Main outcome variables
Effacement, Dilatation, and Duration of Labor

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231121060128N1
Registration date: 2024-01-01, 1402/10/11
Registration timing: prospective

Last update: 2024-01-01, 1402/10/11
Update count: 0
Registration date
2024-01-01, 1402/10/11
Registrant information
Name
Zahra Rahemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 0001
Email address
z.rahemi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-10, 1402/10/20
Expected recruitment end date
2024-07-10, 1403/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of local administration of magnesium sulfate in the latent phase of labor on the improvement of effacement, dilatation, and duration of labor in primiparous and multiparous women
Public title
Comparison of the effectiveness of local administration of magnesium sulfate in the latent phase of labor on the improvement of effacement, dilatation, and duration of labor in primiparous and multiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Singleton pregnancy Cephalic presentation Gestational age, 37-42 weeks Dilatation less than 3 cm Body mass index between 19.8 and 30 kg/m2 Low risk pregnancy
Exclusion criteria:
The infertility treatments in a recent pregnancy Multiple pregnancy History or heart disease in recent pregnancy Having a history of severe allergy to magnesium sulfate The existence of contraindications for natural childbirth, including fetal heart rate disorders, placental abruption, umbilical cord prolapse known pelvic stenosis disorder before the start of labor
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible people will be selected during regular visits and then will be assigned to two intervention groups and one control group using a random sampling method of 6 blocks. For this purpose, blocks of 6 will be selected using a table of random numbers so that the sample size reaches 75 people. Blocking will be done by a person not involved in sampling. Each of the generated random sequences will be recorded on a card and the cards will be placed in the envelopes. Finally, the lids of the envelopes will be glued and placed inside a box. At the start of the intervention to identify the order of the participants, one of the envelopes will be opened in order and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be double-blind. Pregnant women and the person controlling the progress of labor and delivery will not know about the grouping and type of intervention. Examinations and registration of labor progress in the latent phase will be done and recorded every 4 hours by a research associate.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Azadi Square, Central Building of Zanjan University of Medical Sciences, The first floor of the vice-chancellor for research and technology, Zanjan University of Medical Sciences, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2023-11-14, 1402/08/23
Ethics committee reference number
IR.ZUMS.REC.1402.193

Health conditions studied

1

Description of health condition studied
Improvement of dilation, effacement of cervix , and labor duration
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Cervical effacement, dilation, and duration of labor
Timepoint
Before the intervention, 4 hours and then 8 hours after the intervention
Method of measurement
Vaginal examination

2

Description
Hemoglobin and hematocrit
Timepoint
24 hours after delivery
Method of measurement
blood test

Secondary outcomes

empty

Intervention groups

1

Description
Ten cc of 50% magnesium sulfate (up to two doses) will be poured between the fingers on the cervix during the vaginal examination during the latent phase of labor to cover the entire cervix. During the first half hour after using the medicine, the mother will be asked to rest on the bed in order to better absorb the medicine. In case of rupture of the fetal membranes during or less than half an hour after the local use of the drug, 10 cc of magnesium sulfate will be used again after the end of active shedding.
Category
Treatment - Drugs

2

Description
During the latent phase of labor, ten cc of distilled water (up to two doses) will be poured between the fingers on the cervix during the vaginal examination to cover the entire cervix.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital of Zanjan
Full name of responsible person
Zahra Rahmi
Street address
Gavazang Boulevard, Ayatollah Mousavi Zanjan Hospital, Zanjan
City
Zanjan
Province
Zanjan
Postal code
5618345139
Phone
+98 24 3313 0000
Email
Mousavihospital@zums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Samad Nedri
Street address
Azadi Square, Central Builtding of Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6392
Email
research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Rahmi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Gavazang Boulevard, Ait Mousavi Hospital, Zanjan
City
Zanjan
Province
Zanjan
Postal code
56183-45139
Phone
+98 24 3313 0000
Email
z.rahemi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Hamida Gholami
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Gavazang Boulevard, Ayatollah Mousavi Hospital, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6319
Email
gholami@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Rahmi
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Gavazang Road, Ayatollah Mousavi Hospital, Zanjan
City
Zanjan
Province
Zanjan
Postal code
56183-45139
Phone
+98 24 3313 0000
Email
z.rahemi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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