Evaluation of the effect of sildenafil on fetal heart rate patterns during labor in primiparous pregnant women
Design
Clinical trial with control group; With Parallel groups; Single blinded; randomized; design of 200 patients
Settings and conduct
Eligible patients entering the study referred to Imam Sajjad Hospital of Yasuj University of Medical Sciences will be divided into two groups of100 people and the fetal heart rate will be measured.
Participants/Inclusion and exclusion criteria
First and term pregnancy (gestational age over 37 weeks), Absence of pre-eclampsia, hypertension and gestational diabetes and absence of underlying disease in the mother, Not getting magnesium sulfate, Absence of fetal growth restriction, polyhydramnios and oligohydramnios of the fetus, Absence of prolonged rapture of membrane (more than 12 hours), singleton pregnancy
Absence of structural abnormalities, Cephalic display, Candidate for vaginal delivery, Cervical dilatation less than 4 cm at the time of admission, candidate for induction
Intervention groups
Group A: In addition to induction and routine interventions during labor, they will receive oral sildenafil at a dose of 50 mg every 8 hours up to a maximum of 150 mg, the first dose of which is prescribed at the beginning of the study.
Group B: Induction and routine interventions are performed.
Main outcome variables
Fetal heart rate patterns
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160524028038N19
Registration date:2024-02-27, 1402/12/08
Registration timing:prospective
Last update:2024-02-27, 1402/12/08
Update count:0
Registration date
2024-02-27, 1402/12/08
Registrant information
Name
Fatemeh Bazarganipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3366 6367
Email address
bazarganipour@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-04, 1403/01/16
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sildenafil on fetal heart rate patterns during labor in primiparous pregnant women
Public title
Sildenafil and fetal heart rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
First and term pregnancy (gestational age over 37 weeks)
Absence of pre-eclampsia, hypertension and gestational diabetes and absence of underlying disease in the mother
Not getting magnesium sulfate
Absence of fetal growth restriction, polyhydramnios and oligohydramnios of the fetus
Absence of prolonged rapture of membrane (more than 12 hours)
singleton pregnancy
Absence of structural abnormalities
Cephalic display
Candidate for vaginal delivery
Cervical dilatation less than 4 cm at the time of admission
candidate for induction
Exclusion criteria:
Dissatisfaction of the mother
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple. The random allocation sequence will be determined using the "computer Random generation" computer program. The sealed envelopes encoded and non-transparent ( A,B) for the allocation of subjects to intervention ( A) and control (B) groups will be used.
Blinding (investigator's opinion)
Single blinded
Blinding description
The blinding method is patients will not be aware of their allocation to study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, kohgiluyeh and boyer-ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Approval date
2023-05-24, 1402/03/03
Ethics committee reference number
IR.YUMS.REC.1402.037
Health conditions studied
1
Description of health condition studied
Fetal heart rate during labor
ICD-10 code
O76
ICD-10 code description
Abnormality in fetal heart rate and rhythm complicating labor and delivery
Primary outcomes
1
Description
Fetal heart rate patterns
Timepoint
Continuous fetal heart rate monitoring
Method of measurement
In this study, the normal fetal heart rate pattern based on the standard protocol means a heart rate between 110-160 beats per minute and a beat-to-beat variability of 5-25 beats per minute during labor and the pathological fetal heart rate pattern means a late deceleration in heart rate relative to to uterine contractions, early deceleration means a decrease in heart rate at the same time as uterine contractions, variable deceleration means a decrease in heart rate unrelated to uterine contractions, prolong deceleration means a deceleration in heart rate of more than 2 minutes in 10 minutes of continuous heart rate monitoring, tachycardia means a heart rate of more than 160 and bradycardia means a heart rate of less than 110 and reduced variability means changes of less than 5 beats per minute.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to induction and routine interventions during labor, they will receive oral sildenafil at a dose of 50 mg every 8 hours up to a maximum of 150 mg, the first dose of which is prescribed at the beginning of the study.
Category
Treatment - Drugs
2
Description
Control group: Induction and routine interventions are performed.