Preterm labour Pregnancy and Childbirth Preterm labour
Conditions
Interventions
Patients receive a intravenous bolus of saline (500 - 1000 ml) prior to randomisation. They have 1 study patch (drug or placebo) placed and a second additional patch placed after one hour if ongoing u
Sponsors
Queen's University (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Greater than or equal to 24 to less than or equal to 32 weeks gestational age based on menstrual dates or earliest ultrasound scan 2. Preterm labour: 2.1. At least four painful uterine contractions per 20 minutes 2.2. Change in the cervix (change in bishop score or bishop score greater than or equal to 6)
Exclusion criteria
Exclusion criteria: 1. Any maternal (e.g. significant antepartum haemorrhage) or foetal (e.g. non-reassuring heart rate pattern) condition necessitating immediate delivery 2. Multiple gestations (i.e. twins, triplets etc.) 3. Premature prelabour rupture of the membranes (PPROM) 4. Intrauterine foetal demise or lethal foetal anomalies 5. Cervix dilated greater than 8 cm 6. Treatment with another agent within 24 hours 7. Previous enrolment in this trial 8. Known sensitivity to GTN 9. Failure to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neonatal morbidity and prenatal mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Randomisation to delivery interval 2. Incidence of preterm delivery less than 48 hours after initiation of treatment 3. Incidence of delivery within 7 days of commencement of treatment 4. Incidence of delivery prior to 34 weeks gestation 5. Frequency of chorioamnionitis in preterm delivery 6. Frequency of completed course of antenatal corticosteroids 7. Frequency of side effects | — |
Countries
Canada
Outcome results
None listed