Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000748415
Ethics application status
Approved
Date submitted
3/04/2016
Date registered
7/06/2016
Date last updated
30/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative study between Nifedipine, Progesterone and Ritodrine for maintenance tocolysis in management of preterm labour
Scientific title
Comparative study between Nifedipine, Progesterone and Ritodrine for maintenance tocolysis in management of preterm labour prospective randomized trial
Secondary ID [1] 288917 0
nil known
Universal Trial Number (UTN)
Trial acronym
MT OF PTL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
preterm labor 298249 0
Condition category
Condition code
Reproductive Health and Childbirth 298394 298394 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
patients with PTL are randomized into three groups
group(1) will receive CCB (calcium channel blockers) nifedipine oral epilate capsule 20 mg/8 hours till 37 weeks gestation or till delivery whichever occurs first
group two will receive progesterone pessaries containing 400 mg of natural progesterone per pessary one pessary per vaginum at bed time until 37 weeks or till delivery whichever occurs first, regular follow up in the OPD and return of empty packet is strategies will be used to monitor adherence.
Intervention code [1] 294379 0
Treatment: Drugs
Comparator / control treatment
group three will receive Beta sympathomemtic drug in the form of oral ritoderine 10 mg tablet will given every 12 hours till 37 weeks of pregnancy or till delivery whichever occurs first
Control group
Active

Outcomes
Primary outcome [1] 297871 0
the duration of pregnancy prolongation after treatment will be assessed by review of medical record
Timepoint [1] 297871 0
from start of treatment until onset of labour
Secondary outcome [1] 323385 0
Proportion of neonates that do not exhibit any medical conditions and can be taken home within four days of delivery, assessed by review of medical record
Timepoint [1] 323385 0
from time of delivery until patient will be discharged to home
Secondary outcome [2] 323386 0
Proportion of neonates that require placement in intensive care incubator assessed by review of medical records
Timepoint [2] 323386 0
from time of delivery until patient discharged to home
Secondary outcome [3] 323987 0
gestational age at time of delivery
Timepoint [3] 323987 0
gestational age calculated by LMP (1 st day of last menstrual period ) if patient sure of date .
or by Ultrasound if LMP not reliable

Eligibility
Key inclusion criteria
1-Painful, regular uterine contractions associated with boats of diarrhea or associated with menstrual like cramps.
2- Singleton pregnancy.
3- Intact membranes.
4- Cervical dilation of 3cm or less.
5- The dating of pregnancy confirmed through first trimester ultrasound scanning or last menstrual period.
6- all PTL less than 37 weeks
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute attack of preterm labor
Cervical dilatation > 3 cm.
Hypotension (less than 80 mmHg systolic or 50 mmHg diastolic).
Major fetal congenital anomalies.
Unreassuring traces of fetal cardiotocography.
Antepartum hemorrhage or history of recurrent vaginal bleeding
Rupture of membranes.
Multiple pregnancy.
Polyhydraminos.
Chorioamnionitis.
Unexplained pyrexia.
Medical disorders i.e. diabetes, cardiac disease.
Sensitivity or contraindication to nifedipine or beta-agonist.
Other tocolytic therapy during this pregnancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation by simple randomization method by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
serial generated numbers created by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will statistically described in terms of range, mean+/- standard deviation (+/-SD), frequencies (number of cases and percentages when appropriate. Comparisons of quantitative variables between the study groups was done using one way analysis variance (ANOVA) test with postoc multiple 2-group comparisons. Within group comparisons between pre and post treatment values will be done using paired t test. For comparing categorical data, Chi square test will performed. Exact test will be used instead when the expected . the power of significance will considered if P value at or less than 0.05 , level of attrition should not exceed 10-15%
1 2x (Z a +Z beta)2X px (1-p)
N= -------- x [------------------------------]
(1-f) (p0 - p1)2

In which

P0= proportion of participant in control treatment group who are expected to exhibit the outcome of interest.

P1=proportion of participant in treatment group who are expected to exhibit the outcome of interest.

a= the level of significance or probability of type I error
Z a= 1.96 at level of significance 0.05

beta= probability of type II error.

Z beta=1.65 at level of significance 0.05
f= proportion of subjects who are expected to be dropout. Usually = 0
p= (p0+p1)/2.
frequent is less than 5. A probability value (p value) less than 0.05 will be considered statistically significant. All statistical calculations will be done using computer programs Microsoft Excel 2003 (Microsoft Corporation, USA) and SPSS (Statistical Package for the Social Science; SPPS Inc., Chicago, II, USA) version 15 for Microsoft windows.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/07/2016
Actual
16/07/2016
Date of last participant enrolment
Anticipated
29/07/2017
Actual
15/07/2017
Date of last data collection
Anticipated
31/07/2017
Actual
15/07/2017
Sample size
Target
300
Accrual to date
Final
300
Recruitment outside Australia
Country [1] 7766 0
Egypt
State/province [1] 7766 0
Minia

Funding & Sponsors
Funding source category [1] 293264 0
Hospital
Name [1] 293264 0
maternity hospital Minia university
Country [1] 293264 0
Egypt
Primary sponsor type
Hospital
Name
Minia University Maternity Hospital
Address
maternity hospital , Minia university campus,Minia Govern rate Egypt postal code 61519
Country
Egypt
Secondary sponsor category [1] 292067 0
University
Name [1] 292067 0
Minia university
Address [1] 292067 0
Minia university campus,Minia Govern rate Egypt postal code 61519
Country [1] 292067 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294745 0
ethical committee of obstetrics and Gynecology faculty of medicine Minia University
Ethics committee address [1] 294745 0
maternity hospital Minia university campus,Minia Govern rate Egypt postal code 61519
Ethics committee country [1] 294745 0
Egypt
Date submitted for ethics approval [1] 294745 0
03/04/2016
Approval date [1] 294745 0
09/07/2016
Ethics approval number [1] 294745 0

Summary
Brief summary
This is a comparative study that will performed in the period from July 2016 to July 2017. In total 300 patients will be recruited from the Obstetric department in Minia University Hospitals with preterm labor symptoms between 28 and 37 weeks gestation. Participants will be randomised into one of three groups: Group A: 100 patients will receive oral nifedipine (epilate capsules) Epico. Group b: 100 patients will receive progesterone vaginal suppository (prontogest 400 ) IBSA. Group C: 100 patients will receive oral ritodrine (yutopar) Pharco pharmaceuticals. Patients will be followed up weekly in the obstetric outpatient clinic until delivery to detect the date and mode of delivery and the fetal outcome. Repeated episodes of preterm labor that might occur will be recorded and treated with the same treatment group(1) will receive CCB (calcium channel blockers) nifedipine oral epilate capsule 20 mg/8 hours till 37 weeks gestation or till delivery whichever occurs first
group two will receive progesterone pessaries containing 400 mg of natural progesterone per pessary one pessary per vaginum at bed time until 37 weeks or till delivery whichever occurs first, regular follow up in the OPD and return of empty packet is strategies will be used to monitor adherence. Gestational age at delivery, proportion of neonates that not exhibit any medical condition at time of discharge (within 4 days after labour) and proportion of neonates that will need NICU admission will be recorded
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64902 0
Dr Reham Elkhateeb
Address 64902 0
Minia university campus , Minia Govern rate postal code 61519
Country 64902 0
Egypt
Phone 64902 0
+201011966648
Fax 64902 0
Email 64902 0
[email protected]
Contact person for public queries
Name 64903 0
Dr Reham Elkhateeb
Address 64903 0
Minia university campus Minia Govern rate postal code 61519
Country 64903 0
Egypt
Phone 64903 0
+201000222994
Fax 64903 0
Email 64903 0
[email protected]
Contact person for scientific queries
Name 64904 0
Dr Hashim Fares
Address 64904 0
minia university campus Minia , Minia Govern rate postal code 61519
Country 64904 0
Egypt
Phone 64904 0
+20109665924
Fax 64904 0
Email 64904 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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