Comparison of the effect of serum administration of 1.3 and 2.3% Ringer Lactate and Normal Saline on duration of labor, Cesarean section, Serum bilirubin and glucose level and PH of neonatal cord blood in neonatal women undergoing labor induction
Determination of the effect of normal saline-1.3 and 2.3-serum administration on the duration of labor in infants bornto women undergoing labor induction
Design
This study is a two-way blind clinical trial. Individuals are randomized by table of numbers and divided into three groups, then a number is given to each person.The sample sizewas 450 people.This study is two way blind,so that the subject and statistical analyst of the situation The allocation of groups was unaware that only the supervisor was aware of the allocation of groups.The trial phase could not be defined for this study
Settings and conduct
Patients referred to Akbarabadi Hospital who are candidates for entry to study
An equal number of pregnant women entered:In group1 serum normal saline is injected during the labor -group 2 serum normal saline is injected during the labor & group 3 serum ringer is injected during the labor.injection rate is125cc per min for all groups, from the time entery to the delivery room until the end of the birth.The study is two-way blind,and the blinded patient and epidemiologist And a Supervisor is informed
Participants/Inclusion and exclusion criteria
A woman with Gravid1pregnancy with a Bishop score of less than 4 Single pregnancyCephalic Presentation Gestational age greater than37 weeksNO entry: A woman with Gravid1pregnancy with a Bishop score of bigger than 4 multiple pregnancy breach PresentationGestational age less than37weeks
Intervention groups
This study has 3 intervention groups.Group1is injected with normal saline during labor.Group1is injected with1.3-2.3 during labor.Group3 is injected with ringer during labor.The injection rate for all groups is 125 cc per minute from the time of entry into the delivery room until the end of the birth.Control group: Not applicable
Main outcome variables
Cesarean rate
Serum bilirubin level
Baby umbilical cord blood pH
The duration of labor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200202046346N1
Registration date:2020-04-20, 1399/02/01
Registration timing:retrospective
Last update:2020-04-20, 1399/02/01
Update count:0
Registration date
2020-04-20, 1399/02/01
Registrant information
Name
Mina Momeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3625 6451
Email address
momeni.mi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-25, 1398/09/04
Expected recruitment end date
2020-02-29, 1398/12/10
Actual recruitment start date
2019-11-25, 1398/09/04
Actual recruitment end date
2020-02-29, 1398/12/10
Trial completion date
2020-02-29, 1398/12/10
Scientific title
Comparison of the effect of serum administration of 1.3 and 2.3% Ringer Lactate and Normal Saline on duration of labor, Cesarean section, Serum bilirubin and glucose level and PH of neonatal cord blood in neonatal women undergoing labor induction
Public title
The effect of different types of serum therapy on maternal and fetal outcomes during childbirth
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Gravid one
Bishop Score<4
Pregnancy single fetus
Cephalic presentations
Gestational age more than 37 weeks
Exclusion criteria:
Multiparity
Known heart disease that can't handle this fluid volume
Induction contraindications Such as Intrauterine growth restriction (IUGR); Suspicion of Cephalopelvic disproportion (CPD); Breech show member
Patients undergoing cervical ripening
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
450
Actual sample size reached:
450
Randomization (investigator's opinion)
Randomized
Randomization description
After consciously satisfying the individuals, they are randomized by the number table method and divided into three groups. In this method, a number of cards or letters are selected by the researcher as the first group and the same.The number of cards is considered for the next group; then by merging the tasks together(On playing cards) A card is taken out and its allocation is recorded, and that card is returned to the other cards after leaving. Then the cards are merged again and another card is taken out. This process continues until a random sequence is reached according to the sample size. Also, the number of cards or names is not necessarily equal to the total number of samples. For example, theIn a three-group study with a sample size of 300 people and a group ratio of 1: 1, 3 cards can be used He prepared for each group. the software and people are divided into three groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Thus, the subject and statistical analyst are unaware of the status of the allocation of the three groups to the study. The subject is not aware of the allocation status to the groups. The researcher who measures clinical and diagnostic measurements will not be aware of the individual's condition, and the statistical advisor will be unaware of the individual's allocation to the study groups. Only the supervisor, appointed by the university, was aware of the allocation of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Vice Chancellor for International affairs, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-11-24, 1398/09/03
Ethics committee reference number
IR.IUMS.FMD.REC.1398.368
Health conditions studied
1
Description of health condition studied
labor
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The duration of labor
Timepoint
At the beginning of labor and after delivery
Method of measurement
the watch
2
Description
Cesarean section
Timepoint
Postpartum
Method of measurement
Percent
3
Description
Serum bilirubin level
Timepoint
After labor
Method of measurement
Dedicated experiments
4
Description
Baby umbilical cord blood pH
Timepoint
After birth
Method of measurement
Dedicated experiments
Secondary outcomes
empty
Intervention groups
1
Description
intervention Group 1: In this study, an equal number of pregnant women G 1 with Bishop Score less than 4 who have a pregnancy termination indication are included in the study.The first group during delivery (when the patient is brought to the delivery room to induce labor and is ready to give birth on a special bed) is injected with 125 cc of normal saline per minute and continues until after delivery and the birth of the baby, then will be disconnected.
Category
Other
2
Description
intervention Group 2: In this study, an equal number of pregnant women G 1 with Bishop Score less than 4 who have a pregnancy termination indication are included in the study.The first group during delivery (when the patient is brought to the delivery room to induce labor and is ready to give birth on a special bed) is injected with 125 cc of 1/3-2/3 serum per minute and and continues until after delivery and the birth of the baby, then will be disconnected.
Category
Other
3
Description
intervention Group 2: In this study, an equal number of pregnant women G 1 with Bishop Score less than 4 who have a pregnancy termination indication are included in the study.The first group during delivery (when the patient is brought to the delivery room to induce labor and is ready to give birth on a special bed) is injected with 125 cc of ringer serum per minute and and continues until after delivery and the birth of the baby, then will be disconnected.