| Methods |
Computer‐generated randomization with stratification by cervical dilation ( <3 cm versus >= 3 cm) and previous indomethacin use. Research pharmacist prepared identical pump solutions. Participant, investigator and outcome assessor were masked. |
| Participants |
52 women with singleton gestations and intact membranes from 22 to 33 6/7 weeks' gestation with preterm labor, defined as > 4 uterine contractions/hour and at least one of: >= 1 cm cervical dilation; >= 80% cervical effacement; documented cervical change. Only women who received magnesium sulfate therapy and had arrested labor (i.e. < 4 contractions/hour for >= 24 hours) were eligible. Exclusions included contraindications to tocolysis, persistent maternal tachycardia, history of cardiac arrythmia, history of pulmonary edema, uncontrolled diabetes, suspected chorioamnionitis. |
| Interventions |
(1) Terbutaline pump group (n = 24) received 1 mg terbutaline/1 mL saline at 0.05 mL/hour with bolus injections 5 times daily. Participant could self‐administer 0.25 mL twice daily for increased uterine activity. (2) Saline pump group (n = 28) received identical regimen to terbutaline pump group except terbutaline replaced with saline. Both groups received intensive education. |
| Outcomes |
Primary outcome: mean interval time from initiation of maintenance therapy to delivery. Secondary outcomes: episodes of recurrent preterm labor; delivery < 37 weeks, delivery < 34 weeks; gestational age at delivery; mean birthweight; neonatal intensive care stay > 24 hours; respiratory distress syndrome; intraventricular hemorrhage; discontinuations from therapy. |
| Notes |
Sample size designed to have 80% power to detect a 2‐week difference in time to delivery. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
