Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

The investigators current treatment for preterm labor has not been shown to be effective in
prolonging pregnancy sufficiently to improve neonatal outcomes and other treatment strategies
are needed. Multiple examples demonstrate that multi-agent treatments are routine clinical
practice in other fields of medicine including chemotherapeutics for cancer,
multi-therapeutics for myocardial infarction and broad spectrum antibiotics for pneumonia. At
this time, it is unclear if a combination of tocolytic medications for preterm labor is more
advantageous for women. If pregnancy is prolonged with combined tocolytic therapy, this could
directly influence the treatment of preterm labor and potentially improve neonatal outcomes.
There currently are no trials of combination regimens using widely used tocolytic agents,
such as nifedipine and indomethacin. Thus, we propose a comparative effective trial of
nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor

Inclusion Criteria:

- We will include pregnant women between 220/7 to 316/7 weeks gestation who present with
regular uterine contractions defined as at least one contraction every 10 minutes for
30 minutes with at least one of the following:

- cervical change or

- 2 cm dilated or

- positive fetal fibronectin or

- transvaginal cervical length <2.5 cm

Exclusion Criteria:

- We will exclude pregnant women with any contraindication to tocolysis:

- clinical chorioamnionitis (defined as a temperature of >100.4 F and any of the
following: fundal tenderness, maternal tachycardia, fetal tachycardia or purulent
vaginal discharge)

- non reassuring fetal heart tones

- suspected placental abruption

- preterm premature rupture of membranes

- prior tocolytic treatment during their pregnancy

- known adverse effect to indomethacin or nifedipine