Preterm Labor
Conditions
Keywords
preterm labor
Brief summary
RESEARCH HYPOTHESIS -Incidence of preterm delivery is lower in women treated with oral micronized progesterone (Utrogestan) as acute tocolysis agent compare to Nifedipine group with fewer maternal side effect
Interventions
DRUGutrogestan
Oral Tablet Utrogestan 400 mg daily for 2 days
DRUGNifedipine
Tablet Nifedipine 20 mg stat then 20 mg after 30 minutes if contraction persist and another 20mg after 30 minutes if contraction still persist followed by 10 mg three times daily for 2 days
Sponsors
nor zila hassan malek
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
• Singleton pregnancy women between 22 and 34 weeks of gestation who presented with threatened preterm labor.
Exclusion criteria
* Multiple pregnancies * Women with Preterm Prelabour Rupture of Membrane * Fetal death * Women with bad obstetric history * Women with history of cervical incompetence * Contraindication to Nifedipine such as cardiovascular disease, hyperthyroidism, severe pre eclampsia or to Utrogestan * Maternal or fetal indication for immediate delivery, such as fetal distress, bleeding placenta previa, abruption placenta * Contraindication for tocolysis, for example severe pre eclampsia, intrauterine growth restriction, fetal anomaly, chorioamnionitis, significant antepartum haemorrhage * Cervical dilatation of 3cm or more * Patients with previous tocolytic treatment during this pregnancy * Women who refuse to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| latency period interval between time of tocolysis and delivery | 24 hours up to 7 days | delivery less than 24 hours of tocolysis,delivery less than 48 hours of tocolysis, delivery less than 7 days of tocolysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy outcomes | 34 weeks of gestational age | delivery less than 34 weeks of gestation, delivery more than or at 34 weeks of gestation |
| Neonatal outcome | 24 hours | Birth weight (kg),cord blood acidity, need for neonatal intensive care unit admission |
| Maternal side effect | 30 minutes up to 48 hours | Palpitation,Headache, Nausea/Vomiting, Hypotension, Dyspnea, Jaundice, Pruritus |
Countries
Malaysia
Contacts
Primary Contactnor zila hassan malek
Outcome results
None listed