Dexamethasone, Pregnancy
Conditions
Brief summary
Pregnant women with a gestational age of 38 weeks and older admitted to Labor Of Kamali Hospital, for termination of pregnancy, by accident and based on the a statistician did coding to identify groups of users of pill A or pill B, 14 pills are used vaginally. The patients and the researcher is blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher.
Detailed description
Study design: This study was a clinical trial with the control group, blinded, randomized with a block method that was done at Kamali Hospital, Karaj, Iran. This study was carried out between October 2019 and June 2021. At first, the researchers registered this study on the RCT(randomized controlled trial) site with the following number: IR.ABZUMS.REC1399.067. A written consent form was obtained from all patients and the ethics committee of Alborz University of Medical Sciences confirmed the study protocol. Study selection: The sample size required to compare the mean of the two groups, with a 95% confidence interval and 90% test power, and considering the technical difference of 0.5 hours, was estimated to be 84 people. Then patients, randomly assigned using the block method with statistician help, were divided into two groups of 42 cases and control. The present study was performed on 82 full-term pregnant females (38 weeks or more).they had an indication for termination of pregnancy, by accident, and based on the coding done by a statistician to identify groups of users of pill A or pill B, 14 pills are used vaginally. The client and the researcher are blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher. Group A received 14 dexamethasone tablets with a dose of 0.5 mg for vaginal use and also group B received 14 placebo tablets for vaginal use. Patients who were Iranian, Prim gravid pregnancy with Normal Body Mass Index (BMI), Single Pregnancy presentation cephalic in Sonography, Aged 18 years old to 35 years old, Gestational age 38 weeks, Bishop score 2 and less, with Normal Non-Stress Test (NST), Estimate of Fetus Weight 2500-4000 gr and didn't take hormonal, herbal and chemical drugs and having a healthy water bag were enrolled to this Study. Patients who had Medicine and Midwifery Complications, Lack of Desire for Cooperation, Fetal Immobility, and Maternal Bleeding were excluded.
Interventions
Pregnant women with a gestational age of 38 weeks and older admitted to Labor Of Kamali Hospital, for termination of pregnancy, by accident and based on the coding done by a statistician to identify groups of users of pill A or pill B, 14 pills are used vaginally . The client and the researcher are blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher.
DRUGPlacebo
Pregnant women with a gestational age of 38 weeks and older admitted to Labor Of Kamali Hospital, for termination of pregnancy, by accident and based on the coding done by a statistician to identify groups of users of pill A or pill B, 14 pills are used vaginally . The client and the researcher are blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher.
Sponsors
Alborz Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Pregnant women with a gestational age of 38 weeks and older admitted to Labor Of Kamali Hospital, for termination of pregnancy, by accident and based on the coding done by a statistician to identify groups of users of pill A or pill B, 14 pills are used vaginally . The client and the researcher are blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher.
Intervention model description
Subjects are assigned to two groups by randomization block balanced method allocation and using quadruple blocks. In this case, there are 6 modes And in each case, 2 people will be in the control group and 2 people will be in the intervention group. Thus, by using the table of random numbers and assigning the numbers 1 to 6 to groups of 4 people, people are finally assigned to two groups of intervention and control.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Iranian Women * Primigravid pregnancy * Normal of Body Mass Index * Single Pregnancy * presentation cephalic in sonography * Gestational age 38 weeks * Bishop score 2 and less * Normal Non Stress * Test Estimate of Fetus Weight 2500-4000 gr * Didn't take hormonal, herbal and chemical drugs * having a healthy water bag
Exclusion criteria
* Have Medicine And Midwifery Complication * Lack of Desire for Cooperation * Fetal Immobility * Maternal Bleeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Bishop Score | at the beginning of the study | The total Bishop score is calculated by assessing the following five components of manual vaginal examination by a trained professional: Cervical dilation, Cervical effacement, Cervical consistency, Cervical position, and Fetal station. Dilation (score): closed(0), 1-2 cm (1), 3-4cm (2), 5\>= (3) Effacement (score): 0-30% (0), 40-50% (1), 60-70% (2), 80%\>= (3) Consistency (score): Firm (0), moderately firm (1), soft (2) Position (score): posterior (0), mid posterior (1), anterior(2) Station (score): -3 (0), -2 (1), -1 and 0 (2), +1 and +2 (3) The total Bishop's score which sums up all subscores can range from zero to 13, with zero meaning that the patient is not ready for induction and 13 indicating a better chance for successful induction for delivery (outcome). |
| Second Bishop Score | 6 hours after vaginally tablets installment | The total Bishop score is calculated by assessing the following five components of manual vaginal examination by a trained professional: Cervical dilation, Cervical effacement, Cervical consistency, Cervical position, and Fetal station. Dilation (score): closed(0), 1-2 cm (1), 3-4cm (2), 5\>= (3) Effacement (score): 0-30% (0), 40-50% (1), 60-70% (2), 80%\>= (3) Consistency (score): Firm (0), moderately firm (1), soft (2) Position (score): posterior (0), mid posterior (1), anterior(2) Station (score): -3 (0), -2 (1), -1 and 0 (2), +1 and +2 (3) The total Bishop's score which sums up all subscores can range from zero to 13, with zero meaning that the patient is not ready for induction and 13 indicating a better chance for successful induction for delivery (outcome). |
| The Latent Phase of Labor | from the beginning of the study to the time of 6 cm dilation of cervix | measured by Vaginal Examination |
Countries
Iran
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A Prescribing Vaginally Dexamethasone tablets to the Group A
Dexamethasone 0.5mg: Pregnant women with a gestational age of 38 weeks and older admitted to Labor Of Kamali Hospital, for termination of pregnancy, by accident and based on the coding done by a statistician to identify groups of users of pill A or pill B, 14 pills are used vaginally . The client and the researcher are blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher. | 42 |
| Group B Prescribing Vaginally placebo tablets to the Group B
Placebo: Pregnant women with a gestational age of 38 weeks and older admitted to Labor Of Kamali Hospital, for termination of pregnancy, by accident and based on the coding done by a statistician to identify groups of users of pill A or pill B, 14 pills are used vaginally . The client and the researcher are blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher. | 42 |
| Total | 84 |
Baseline characteristics
| Characteristic | Total | Group A | Group B |
|---|---|---|---|
| Age, Continuous | 24 years | 25 years | 23 years |
| Education Associate's degree | 4 Participants | 2 Participants | 2 Participants |
| Education Bachelor's degree or higher | 7 Participants | 4 Participants | 3 Participants |
| Education High school | 35 Participants | 16 Participants | 19 Participants |
| Education Illiterate | 10 Participants | 4 Participants | 6 Participants |
| Education Junior school | 21 Participants | 14 Participants | 7 Participants |
| Education Primary school | 7 Participants | 2 Participants | 5 Participants |
| Gravidity and parity G1ab1 | 82 Participants | 42 Participants | 40 Participants |
| Gravidity and parity G1ab2 | 1 Participants | 0 Participants | 1 Participants |
| Gravidity and parity G1ab3 | 1 Participants | 0 Participants | 1 Participants |
| Job employed | 7 Participants | 5 Participants | 2 Participants |
| Job Unemployed | 77 Participants | 37 Participants | 40 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 84 Participants | 42 Participants | 42 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 |
| other Total, other adverse events | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
Primary
First Bishop Score
The total Bishop score is calculated by assessing the following five components of manual vaginal examination by a trained professional: Cervical dilation, Cervical effacement, Cervical consistency, Cervical position, and Fetal station. Dilation (score): closed(0), 1-2 cm (1), 3-4cm (2), 5\>= (3) Effacement (score): 0-30% (0), 40-50% (1), 60-70% (2), 80%\>= (3) Consistency (score): Firm (0), moderately firm (1), soft (2) Position (score): posterior (0), mid posterior (1), anterior(2) Station (score): -3 (0), -2 (1), -1 and 0 (2), +1 and +2 (3) The total Bishop's score which sums up all subscores can range from zero to 13, with zero meaning that the patient is not ready for induction and 13 indicating a better chance for successful induction for delivery (outcome).
Time frame: at the beginning of the study
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexamethasone | First Bishop Score | 1 score on a scale |
| Placebo | First Bishop Score | 1 score on a scale |
p-value: 0.618Wilcoxon (Mann-Whitney)
Primary
Second Bishop Score
The total Bishop score is calculated by assessing the following five components of manual vaginal examination by a trained professional: Cervical dilation, Cervical effacement, Cervical consistency, Cervical position, and Fetal station. Dilation (score): closed(0), 1-2 cm (1), 3-4cm (2), 5\>= (3) Effacement (score): 0-30% (0), 40-50% (1), 60-70% (2), 80%\>= (3) Consistency (score): Firm (0), moderately firm (1), soft (2) Position (score): posterior (0), mid posterior (1), anterior(2) Station (score): -3 (0), -2 (1), -1 and 0 (2), +1 and +2 (3) The total Bishop's score which sums up all subscores can range from zero to 13, with zero meaning that the patient is not ready for induction and 13 indicating a better chance for successful induction for delivery (outcome).
Time frame: 6 hours after vaginally tablets installment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexamethasone | Second Bishop Score | 3.5 score on a scale |
| Placebo | Second Bishop Score | 3 score on a scale |
p-value: 0.483Wilcoxon (Mann-Whitney)
Primary
The Latent Phase of Labor
measured by Vaginal Examination
Time frame: from the beginning of the study to the time of 6 cm dilation of cervix
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexamethasone | The Latent Phase of Labor | 4 hour |
| Placebo | The Latent Phase of Labor | 5 hour |
p-value: 0.571Wilcoxon (Mann-Whitney)