Evaluation of the effect of a complete course of betamethasone on neonatal and mothers with Premature rupture of membranes at 34 to 36 weeks of pregnancy
Assessing the efficacy of Betamethasone in pregnant women with PROM at 34 to 36 week of gestational age
Design
A randomized clinical trial with a parallel control group, phase 3, 100 patients in each group; Randomization using the random numbers table.
Settings and conduct
In Mahdieh hospital in Tehran, eligible pregnant women will be divided into intervention and control groups with simple randomization technique using a table of random numbers. In 100 women in the intervention group, 12 mg of betamethasone will be injected intramuscularly on the first day and another 12 mg 24 hours later.
Betamethasone will not be injected in 100 women the control group.
The outcomes related to mother and baby in these two groups will be followed up and recorded. Concealment is not possible for the patient and the researcher in terms of the type of intervention, and only the data collection and information analysis group will be unaware of the placement of the patient in the test or control group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
PROM at 34 to 36 week of GA; single gestation. Exclusion Criteria: Chorioamnionitis; 48 hours passed from the rupture of the membrane; maternal fever; maternal tachycardia; indication for emergency termination of pregnancy; maternal diabetes; no consent for being in this research.
Intervention groups
Intervention group: Pregnant women with PROM at 34 to 36 week of GA who will receive Betamethasone
Control group: Pregnant women with PROM at 34 to 36 week of GA who will not receive Betamethasone
Main outcome variables
Neonatal Respiratory Distress Score;
Need for surfactant;
Neonatal Mechanical Ventilation Days;
Days of hospitalization in neonates;
Neonatal mortality rates during 28 days after birth;
maternal infection.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221010056141N1
Registration date:2022-12-20, 1401/09/29
Registration timing:prospective
Last update:2022-12-20, 1401/09/29
Update count:0
Registration date
2022-12-20, 1401/09/29
Registrant information
Name
Zahra Fahmfam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 2628
Email address
zahra.fahmfam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of a complete course of betamethasone on neonatal and mothers with Premature rupture of membranes at 34 to 36 weeks of pregnancy
Public title
Effect of Betamethasone in mothers with PROM
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers with Premature rupture of membranes
At 34 to 36 weeks of pregnancy
Singleton pregnancy
Exclusion criteria:
Symptoms of chorioamnionitis in mother:fever, tachycardia
Infants small for gestational age
Infants large for gestational age
Any indication of emergency termination confirmed by fetal assessment
Maternal diabetes
Passing more than 48 hours from rupture of membrane
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization in such a way that the last digit of the patient file number is placed in the intervention group if it is even, and in the control group if it is odd.
Blinding (investigator's opinion)
Single blinded
Blinding description
data collection and information analysis group will be unaware of the placement of the patient in the test or control group.The primary data will be provided to the data analysis group without mentioning the name of the group in the form of group A, B
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics Committees of School of Medicine-Shahid Beheshti University of Medical Sciences
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419943471
Approval date
2022-06-07, 1401/03/17
Ethics committee reference number
IR.SBMU.MSP.REC.1401.135
Health conditions studied
1
Description of health condition studied
Premature Rupture of Membrane
ICD-10 code
O42
ICD-10 code description
Premature rupture of membranes
Primary outcomes
1
Description
RDS Score
Timepoint
after birth of neonate
Method of measurement
Completion of RDS Score with inspection and auscultation
2
Description
APGAR Score
Timepoint
1 and 5 minute after birth
Method of measurement
inspection of neonate
3
Description
need for Surfactant administration
Timepoint
during first 3 day of life
Method of measurement
medical record of neonate
4
Description
maternal chorioamniotitis
Timepoint
since rupture of membrane till 48 hours after delivery, every 6 hours
Method of measurement
existence of clinical signs : fever and tachycardia
Secondary outcomes
1
Description
local infection of mother
Timepoint
One week till one month after delivery. Daily during hospitalization and weekly after discharge
Method of measurement
Observation of c section incision and perineum of mother and assessment for infection signs
2
Description
neonatal death
Timepoint
28 days after birth
Method of measurement
neonatal medical record
Intervention groups
1
Description
Mothers with premature rupture of membrane between 34 to 36 weeks of gestational age, in which betamethasone ampoule with a dose of 12 mg (3 ampoules of 4 mg at once) is injected intramuscularly into the Gluteus muscle. 24 hours later, the second dose will be repeated in the same way. Betamethasone ampoule used is a product of Caspian Pharmaceutical Company.
Category
Treatment - Drugs
2
Description
Control group: Pregnant women with premature rupture of membrane that Betamethasone was not injected at 34 to 36 week of gestational age