The effect of cervical Hyoscine on the length of the first and second stages of labor of nulliparous women referred to Niknafs maternity hospital in Rafsanjan: A clinical trial
The effect of cervical hyoscine on the first and second stages length of labor in primiparous women referring to Niknafs hospital
Design
Clinical trial, with control group, with parallel groups, one blind, by randomization method through computer software will be divided into experimental and control groups.
Settings and conduct
This one-blind clinical trial will performe in 2021 on 120 primiparous women referring to Niknfs hospital in Rafsanjan. After explaining the purpose and period of the study and obtaining informed consent from the samples, they will assign in the experimental and control groups. The control group give one milliliter of single-dose distilled water with cervicovaginal syringes. All people should have at least 4 cm of dilatation and regular uterine contractions when administering cervicovaginal medication, and their membranes should be intact. The contents of the syringes and vaginal examinations will be injected by one person.
Participants/Inclusion and exclusion criteria
eligibility criteria: primiparas, full-term pregnancy, alive singleton with cephaic presentation, intact membranes
people with a history of maternal medical diseases including cardiovascular diseases, tachycardia as well as vaginal bleeding, temperature above 38 ° C, history of conization and cervical resection by loop electric method will be excluded from the study.
Intervention groups
The experimental group give one milliliter dose of Hyoscine (equivalent to 20 mg) and the control group give one milliliter distilled water with needleless syringes (the drug will be poured on the upper edge of the cervix).
Main outcome variables
The length of the first and second stages of labor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181219042051N3
Registration date:2021-08-14, 1400/05/23
Registration timing:registered_while_recruiting
Last update:2021-08-14, 1400/05/23
Update count:0
Registration date
2021-08-14, 1400/05/23
Registrant information
Name
Zohreh Ghorashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
zghorashi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cervical Hyoscine on the length of the first and second stages of labor of nulliparous women referred to Niknafs maternity hospital in Rafsanjan: A clinical trial
Public title
The effect of cervical Hyoscine on the length of the first and second stages of labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Nulliparous
Term pregnancy
Single pregnancy
alive fetus
Cephalic presentation
Intact membranes
Exclusion criteria:
People with a history of maternal medical diseases, including cardiovascular disease
Tachycardia
Vaginal bleeding
Temperatures above 38 ° C
History of conization
History of cervical resection by loop method
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
random assignment by computerized method. 60 words of intervention and 60 words of control are given to the computer to randomly arrange them. This way we have a list in which 60 intervention words and 60 control words are randomly mixed.Then, eligible samples assign in intervention or control groups following this arrangement.
Blinding (investigator's opinion)
Single blinded
Blinding description
parturient are not going to be aware of the agents that be used in their vagina.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Rafsanjan university of medical sciences
Street address
school of nursing midwifery. parastar street. rafsanjan. Iran
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2021-04-20, 1400/01/31
Ethics committee reference number
IR.RUMS.REC.1400.095
Health conditions studied
1
Description of health condition studied
The length of second stages of labor of neonate
ICD-10 code
ICD-10 code description
2
Description of health condition studied
The length of the third stage of labor
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Apgar score of one and five minute
ICD-10 code
ICD-10 code description
4
Description of health condition studied
postpartum abnormal hemorrhage
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The length of the first stage of labor
Timepoint
once after delivery
Method of measurement
According to the contents of the patient file, the time interval between dilatation is 4 cm until complete dilatation
2
Description
Length of the second stage of labor
Timepoint
once after delivery
Method of measurement
According to the contents of the patient file, the interval between complete dilatation and complete departure of the fetus
Secondary outcomes
1
Description
The length of the third stage of labor
Timepoint
after placental delivery
Method of measurement
According to the contents of the patient file, the time interval between the complete departure of the fetus and the time of the departure of the placenta
2
Description
neonate Apgar score
Timepoint
first and fifth minute after delivery
Method of measurement
Apgar score in the first and fifth minutes after birth
3
Description
Postpartum hemorrhage
Timepoint
two hours postpartum
Method of measurement
Bleeding up to two hours after delivery and diagnosis based on the measures needed to manage postpartum hemorrhage and diagnose midwife
Intervention groups
1
Description
Intervention group: The test group is given a single dose of 1 ml hyoscine vial (equivalent to 20 mg) with needleless syringes cervicovaginally (the drug will be poured on the upper edge of the cervix). All people should have at least 4 cm of dilatation and regular uterine contractions when administering cervicovaginal medication, and their water bag should be healthy.
Category
Treatment - Other
2
Description
Control group: The control group is given 1 ml of single-dose distilled water with needleless syringes of the cervix (the drug is poured on the upper edge of the cervix). When using cervical medicine, all people should have at least 4 cm of regular uterine dilation and contraction, and their bladder should be healthy.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rafsanjan Niknafs Maternity Hospital
Full name of responsible person
zohreh ghorashi
Street address
Niknafs Maternity Hospital- Shohada Street - Rafsanjan