None listed
Conditions
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
Interventions
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 monit
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.
Sponsors
Minia University Maternity Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
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
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.
Outcome results
None listed