Methods |
RCT. Randomisation from a random number table via sealed envelopes.
Blinding: not stated.
Losses to follow‐up: 22 women out of 113 (19.4%) were excluded after randomisation; 6 of these were for non‐compliance. |
Participants |
113 women who met the following inclusion criteria: singleton pregnancy; gestational age 20‐35 weeks; irregular uterine contractions with clear evidence of cervical dilatation and effacement; persistent, regular uterine contractions (min frequency 8/hr) with or without cervical change.
Exclusion criteria: known lethal fetal anomalies, chorioamnionitis, advanced cervical effacement and dilation (completely effaced and > 5 cm dilated). |
Interventions |
Parenteral tocolysis was given to all women (subcutaneous terbutaline and intravenous ritodrine) then women were randomly assigned to maintenance therapy with oral terbutaline (begun at 2.5 mg every 2 hours for 24 hours, then adjusted to 5 mg every 4 hours) or ritodrine (begun at 10 mg every 2 hours for 24 hours then adjusted to 20 mg every 4 hours). Terbutaline = 30 mg/day, ritodrine = 120 mg/ day. |
Outcomes |
Mean birthweight, perinatal deaths, hyperbilirubinaemia, tachycardia, tachypnoea, nausea/vomiting, antenatal readmission. |
Notes |
1 woman in each group was switched to the alternate drug because of intolerable side effects. In addition, there were 6 noncompliant women ‐ 4 from the ritodrine group and 2 from the terbutaline group. 2 of the 6 women chose to give birth elsewhere and the remaining 4 elected not to continue their medication because of side effects. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Random number table. |
Allocation concealment (selection bias) |
Low risk |
Sealed envelopes. |
Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Not stated. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
19% loss to follow‐up. |
Selective reporting (reporting bias) |
Unclear risk |
Unable to assess. |
Other bias |
Low risk |
|